Trial Outcomes & Findings for Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma (NCT NCT04276090)
NCT ID: NCT04276090
Last Updated: 2023-07-25
Results Overview
The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
approximately 4 weeks
Results posted on
2023-07-25
Participant Flow
Participant milestones
| Measure |
Colorectal Liver Metastases
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
4
|
|
Overall Study
COMPLETED
|
16
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Colorectal Liver Metastases
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Overall Study
Rapid disease progression after surgery led to liver dysfunction; prevented administration of HAI
|
1
|
0
|
Baseline Characteristics
Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma
Baseline characteristics by cohort
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40-70 years
|
17 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
4 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 4 weeksThe percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination.
Outcome measures
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy
|
16 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 daysTabulation of CTCAE serious adverse events attributed to pump implantation
Outcome measures
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
30-day Postoperative Serious Adverse Events Related to Pump Implantation
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysQuantify the percent of patients with inability to meet primary outcome due to catheter disconnects.
Outcome measures
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
30-day Catheter Malfunction Due to Tubing Disconnect
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysQuantify the percent of patients with inability to meet primary outcome due to inability to access pump.
Outcome measures
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
30-day Catheter Malfunction Due to Inability to Access Pump
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 4 weeksPercentage of patients who need secondary intervention (IR embolization, revision of pump or tubing) to achieve primary pump function.
Outcome measures
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediate, determined at screening visitPatients are screen using a psychosocial assessment tool for high risk of hepatic artery pump loss/failure, percent declined will be tabulated.
Outcome measures
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 6 monthsPercent of patients that experience pump loss/failure due to inability to attend scheduled followup appointments will be tabulated.
Outcome measures
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe number of staff contacts (phone calls) to assure patients keep their followup visits will be tabulated.
Outcome measures
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsThe percentage of patients who remain on pump chemotherapy at 3 months will be tabulated.
Outcome measures
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months.
|
14 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: At the 6 month time point for this outcome there were only 14 evaluable participants for response rate due to attrition, death, or sub-RECIST threshold disease.
RECIST v1.1 will be used to assess overall response rate at 6 months.
Outcome measures
| Measure |
Colorectal Liver Metastases
n=11 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=3 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Overall Response Rate at 6 Months
Progressive Disease
|
4 Participants
|
2 Participants
|
|
Overall Response Rate at 6 Months
Stable Disease
|
6 Participants
|
1 Participants
|
|
Overall Response Rate at 6 Months
Partial Response
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe percent of patients who are downstaged and undergo surgery will be tabulated.
Outcome measures
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Percent of Patients Who Are Downstaged and Undergo Surgery
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe percentage of patients who remain on pump chemotherapy at 6months will be tabulated.
Outcome measures
| Measure |
Colorectal Liver Metastases
n=17 Participants
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 Participants
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 6 Months.
|
13 Participants
|
3 Participants
|
Adverse Events
Colorectal Liver Metastases
Serious events: 15 serious events
Other events: 17 other events
Deaths: 3 deaths
Intrahepatic Cholangiocarcinoma
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Colorectal Liver Metastases
n=17 participants at risk
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 participants at risk
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/17 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Other
|
0.00%
0/17 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
Disease progression
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Infections and infestations
Other
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Immune system disorders
Sepsis
|
11.8%
2/17 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Investigations
Neutrophil count decreased
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Investigations
White blood cell count decreased
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Investigations
Lymphocyte count decreased
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Investigations
Creatinine increased
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
Other adverse events
| Measure |
Colorectal Liver Metastases
n=17 participants at risk
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
|
Intrahepatic Cholangiocarcinoma
n=4 participants at risk
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
88.2%
15/17 • Number of events 15 • 6 months
|
75.0%
3/4 • Number of events 3 • 6 months
|
|
Blood and lymphatic system disorders
Other
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
35.3%
6/17 • Number of events 6 • 6 months
|
0.00%
0/4 • 6 months
|
|
Cardiac disorders
Ventricular tachycardia
|
23.5%
4/17 • Number of events 4 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
41.2%
7/17 • Number of events 7 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
29.4%
5/17 • Number of events 5 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
64.7%
11/17 • Number of events 11 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Other
|
11.8%
2/17 • Number of events 2 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastroparesis
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Ileus
|
23.5%
4/17 • Number of events 4 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Mucisitis Oral
|
11.8%
2/17 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
82.4%
14/17 • Number of events 14 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Oral pain
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
35.3%
6/17 • Number of events 6 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
General disorders
Edema limbs
|
5.9%
1/17 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
Fatigue
|
70.6%
12/17 • Number of events 12 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
General disorders
Fever
|
17.6%
3/17 • Number of events 3 • 6 months
|
0.00%
0/4 • 6 months
|
|
General disorders
Pain
|
11.8%
2/17 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Injury, poisoning and procedural complications
Bruising
|
11.8%
2/17 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Injury, poisoning and procedural complications
Seroma
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
17/17 • Number of events 17 • 6 months
|
100.0%
4/4 • Number of events 4 • 6 months
|
|
Investigations
Alkaline phosphatase increased
|
82.4%
14/17 • Number of events 14 • 6 months
|
75.0%
3/4 • Number of events 3 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
17/17 • Number of events 17 • 6 months
|
100.0%
4/4 • Number of events 4 • 6 months
|
|
Investigations
Blood bilirubin increased
|
58.8%
10/17 • Number of events 10 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.8%
2/17 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Investigations
Creatinine increased
|
5.9%
1/17 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
INR increased
|
11.8%
2/17 • Number of events 2 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
Lipase increased
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Investigations
Lymphocyte count decreased
|
64.7%
11/17 • Number of events 11 • 6 months
|
75.0%
3/4 • Number of events 3 • 6 months
|
|
Investigations
Neutrophil count decreased
|
41.2%
7/17 • Number of events 7 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Investigations
Platelet count decreased
|
41.2%
7/17 • Number of events 7 • 6 months
|
100.0%
4/4 • Number of events 4 • 6 months
|
|
Investigations
White blood cell decreased
|
29.4%
5/17 • Number of events 5 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
17.6%
3/17 • Number of events 3 • 6 months
|
75.0%
3/4 • Number of events 3 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
47.1%
8/17 • Number of events 8 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
17.6%
3/17 • Number of events 3 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.8%
2/17 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
64.7%
11/17 • Number of events 11 • 6 months
|
75.0%
3/4 • Number of events 3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Nervous system disorders
Dysarthria
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Nervous system disorders
Hypersomnia
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Nervous system disorders
Other
|
5.9%
1/17 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Nervous system disorders
Paresthesia
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
35.3%
6/17 • Number of events 6 • 6 months
|
50.0%
2/4 • Number of events 2 • 6 months
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Psychiatric disorders
Delirium
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Renal and urinary disorders
Urinary retention
|
23.5%
4/17 • Number of events 4 • 6 months
|
0.00%
0/4 • 6 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Reproductive system and breast disorders
Genital edema
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.8%
2/17 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.6%
3/17 • Number of events 3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.6%
3/17 • Number of events 3 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Other
|
11.8%
2/17 • Number of events 2 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Vascular disorders
Hypotension
|
11.8%
2/17 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/17 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/17 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/17 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
Chills
|
0.00%
0/17 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
11.8%
2/17 • Number of events 2 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
64.7%
11/17 • Number of events 11 • 6 months
|
100.0%
4/4 • Number of events 4 • 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
82.4%
14/17 • Number of events 14 • 6 months
|
75.0%
3/4 • Number of events 3 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
76.5%
13/17 • Number of events 13 • 6 months
|
100.0%
4/4 • Number of events 4 • 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
70.6%
12/17 • Number of events 12 • 6 months
|
75.0%
3/4 • Number of events 3 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
58.8%
10/17 • Number of events 10 • 6 months
|
75.0%
3/4 • Number of events 3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/17 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • 6 months
|
100.0%
4/4 • Number of events 4 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place