Trial Outcomes & Findings for Pancreas Resection With and Without Drains (NCT NCT01441492)

NCT ID: NCT01441492

Last Updated: 2020-08-31

Results Overview

The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 399 participants
• Primary outcome timeframe: 60 days
• Results posted on: 2020-08-31

Participant Flow

Participant milestones

Measure	No Drains Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
Overall Study STARTED	197	202
Overall Study COMPLETED	170	174
Overall Study NOT COMPLETED	27	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pancreas Resection With and Without Drains

Baseline characteristics by cohort

Measure	No Drains n=170 Participants Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 Participants Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).	Total n=344 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	61 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	102 Participants n=7 Participants	205 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	72 Participants n=7 Participants	139 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	4 Participants n=5 Participants	5 Participants n=7 Participants	9 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	17 Participants n=5 Participants	25 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) White	126 Participants n=5 Participants	123 Participants n=7 Participants	249 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	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days

The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.

Outcome measures

Measure	No Drains n=170 Participants Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 Participants Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
60-day ≥ Grade II Complication Rate	72 Participants	76 Participants

SECONDARY outcome

Timeframe: 60 days

This secondary outcome measure was defined as the number of patients with one or more complications with grade 3 or higher grade within 60 days of the date of surgery. Complications will be graded in severity suing the Common Terminology Criteria for Adverse Events, CTCAE(v4.0) (Grade 1-5). For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.

Outcome measures

Measure	No Drains n=170 Participants Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 Participants Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
60-day ≥ Grade III Complication Rate	44 Participants	51 Participants

SECONDARY outcome

Timeframe: 60 days

This secondary outcome measure is the number of patients with one or more SAE within 60 days of the date of surgery. This outcome will be presented in the Adverse Event Module. The total number of patients affected were 344 (# of no drain=170 vs # of drain=174) and two patients were experienced the serious adverse event (SAE) defined by the protocol. Refer to the Adverse events tables for specifics.

Outcome measures

Measure	No Drains n=170 Participants Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 Participants Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
Serious Adverse Event (SAE) Rate	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 60 days

This will be calculated for all patients and among just the patients who experienced complications. The complication will be graded in severity using the Common Terminology Criteria for Adverse Events, CTCAE (v4.0) and the severity grade is from 1 to 5. The outcome measure is the median of the Sum of the complication grades of each complication experienced by the patient/# of complications experienced

Outcome measures

Measure	No Drains n=170 Participants Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 Participants Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
Median Complication Severity Grade All patients	1 severity grade Interval 0.0 to 4.0	1 severity grade Interval 0.0 to 4.0
Median Complication Severity Grade For just the patients with complications	4 severity grade Interval 2.0 to 7.0	3 severity grade Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: 60 days

This is the median number of complications per patients.

Outcome measures

Measure	No Drains n=170 Participants Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 Participants Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
60-day Frequency of Complications	1 Complications per patient Interval 0.0 to 2.0	1 Complications per patient Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Measure	No Drains n=170 Participants Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 Participants Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
90-day Mortality Rate	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 60 days

The outcome measure is the number of patients with each particular complication but not including serious adverse events. The complication is using using the Common Terminology Criteria for Adverse Events CTCAE (v4.0).

Outcome measures

Measure	No Drains n=170 Participants Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 Participants Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
Rate of Specific Complications Pancreatic_leak_fistula	20 Participants	88 Participants
Rate of Specific Complications Postoperative_Abdominal_FluidCollection	38 Participants	15 Participants
Rate of Specific Complications Biliary_leak	1 Participants	1 Participants
Rate of Specific Complications Enteric_leak	2 Participants	1 Participants
Rate of Specific Complications Lymph_Leak	1 Participants	1 Participants
Rate of Specific Complications Diarrhea	17 Participants	9 Participants
Rate of Specific Complications Gastroparesis_DelayedGastricEmptying	9 Participants	10 Participants
Rate of Specific Complications SmallBowelObstruction	1 Participants	3 Participants
Rate of Specific Complications Seroma	3 Participants	3 Participants
Rate of Specific Complications Intra_abd_abscess	13 Participants	15 Participants
Rate of Specific Complications Wound_Dehiscence	6 Participants	4 Participants
Rate of Specific Complications Wound_Infection	5 Participants	8 Participants
Rate of Specific Complications Fever	36 Participants	30 Participants

SECONDARY outcome

Timeframe: 60 days

This is the median of length of stay for the index admission. An index admission is an admission in a hospital with a principal diagnosis of a specified condition that meets the inclusion and exclusion criteria for that measure. Total days in the hospital within 60 days of surgery was not collected for analysis. Only length of stay for the index admission was reported.

Outcome measures

Measure	No Drains n=170 Participants Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 Participants Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
Length of Stay for the Index Admission	5 days Interval 4.0 to 6.0	5 days Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: 60 days

Population: Data were not collected for analysis

This is the crude cost of subsequent procedures (CT scan, paracentesis, percutaneous drainage, reoperation) and the length of the index admission and any subsequent readmission. Data were not collected for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days and 60 days

Population: The result is the quality of score at 30 days.

Subjects will complete the FACT-PA quality of life instrument and the results will be recorded. The quality of life scores at 30 days was collected for analysis.

The Functional Assessment of Cancer Therapy-Pancreatic Cancer (FACT-PA), is a self-administered pancreas-specific health status survey. The instrument is scored on a scale of 0-28 for Physical well-being subscale(PWB), Social/Family well-being subscale(SWB), Functional well-being subscale(FWB), and on a scale of 0-24 for Emotional well-being subscale(EWB), and on a scale of 0-36 for additional condition of FACT-PA (FACT-PA subscale). The total FACT-G score is the sum of PWB, SWB, FWB, and EWB and the range of 0~108. The total FACT-PA score is the sum of the total FACT-G score and FACT-Pa subscale and the range of 0~144. A lower score represents the worst quality of life.

Outcome measures

Measure	No Drains n=170 Participants Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 Participants Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
Composite Quality of Life Scores Physical well-being subscale	21 score on a scale Interval 14.0 to 27.0	21 score on a scale Interval 16.0 to 24.0
Composite Quality of Life Scores Social/Family well-being subscale	21 score on a scale Interval 12.0 to 22.0	21 score on a scale Interval 18.0 to 22.0
Composite Quality of Life Scores Emotional well-being subscale	20 score on a scale Interval 18.0 to 23.0	20 score on a scale Interval 17.0 to 23.0
Composite Quality of Life Scores Functional well-being subscale	17 score on a scale Interval 12.0 to 22.0	17 score on a scale Interval 12.0 to 21.0
Composite Quality of Life Scores Total FACT-G score	79 score on a scale Interval 63.0 to 88.0	79 score on a scale Interval 66.0 to 87.0
Composite Quality of Life Scores FACT-Pa subscale	25 score on a scale Interval 21.0 to 28.0	26 score on a scale Interval 21.0 to 29.0
Composite Quality of Life Scores Total FACT-Pa score	104 score on a scale Interval 84.0 to 114.0	105 score on a scale Interval 87.0 to 116.0

Adverse Events

No Drains

Serious events: 2 serious events

Other events: 99 other events

Deaths: 0 deaths

Drains

Serious events: 0 serious events

Other events: 130 other events

Deaths: 0 deaths

Serious adverse events

Measure	No Drains n=170 participants at risk Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 participants at risk Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
Surgical and medical procedures Grade 3 intra-abdominal infection and pancreatic leak/fistula	1.2% 2/170 • Number of events 2 • 30 days and 60 days	0.00% 0/174 • 30 days and 60 days

Other adverse events

Measure	No Drains n=170 participants at risk Patients did not receive intraperitoneal drainage following pancreas resection. No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.	Drains n=174 participants at risk Patients did receive drain(s), the standard of care treatment, following pancreas resection. Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).
Gastrointestinal disorders Pancreatic_leak_fistula	11.8% 20/170 • 30 days and 60 days	50.6% 88/174 • 30 days and 60 days
Gastrointestinal disorders Postoperative_Abdominal_FluidCollection	22.4% 38/170 • 30 days and 60 days	8.6% 15/174 • 30 days and 60 days
Gastrointestinal disorders Biliary_leak	0.59% 1/170 • 30 days and 60 days	0.57% 1/174 • 30 days and 60 days
Gastrointestinal disorders Enteric_leak	1.2% 2/170 • 30 days and 60 days	0.57% 1/174 • 30 days and 60 days
Gastrointestinal disorders Lymph_Leak	0.59% 1/170 • 30 days and 60 days	0.57% 1/174 • 30 days and 60 days
Gastrointestinal disorders Diarrhea	10.0% 17/170 • 30 days and 60 days	5.2% 9/174 • 30 days and 60 days
Gastrointestinal disorders Gastroparesis_DelayedGastricEmptying	5.3% 9/170 • 30 days and 60 days	5.7% 10/174 • 30 days and 60 days
Gastrointestinal disorders SmallBowelObstruction	0.59% 1/170 • 30 days and 60 days	1.7% 3/174 • 30 days and 60 days
Infections and infestations Seroma	1.8% 3/170 • 30 days and 60 days	1.7% 3/174 • 30 days and 60 days
Infections and infestations Intra_abd_abscess	7.6% 13/170 • 30 days and 60 days	8.6% 15/174 • 30 days and 60 days
Infections and infestations Wound_Dehiscence	3.5% 6/170 • 30 days and 60 days	2.3% 4/174 • 30 days and 60 days
Infections and infestations Wound_Infection	2.9% 5/170 • 30 days and 60 days	4.6% 8/174 • 30 days and 60 days
Infections and infestations Fever	21.2% 36/170 • 30 days and 60 days	17.2% 30/174 • 30 days and 60 days

Additional Information

Amy McElhany, Clinical Research Manager

Baylor College of Medicine

Phone: 7137981016

Email: pancreas@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place