Trial Outcomes & Findings for In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors (NCT NCT01236300)
NCT ID: NCT01236300
Last Updated: 2016-06-08
Results Overview
Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.
COMPLETED
NA
66 participants
October 2011
2016-06-08
Participant Flow
Participant milestones
| Measure |
nCLE System
Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors
Baseline characteristics by cohort
| Measure |
nCLE System
n=66 Participants
Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
|
|---|---|
|
Age, Continuous
|
63.1 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: October 2011Population: Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.
Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.
Outcome measures
| Measure |
nCLE System (Stage 2)
n=31 Participants
Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
|
|---|---|
|
Sensitivity
|
59 percentage of participants
Interval 36.0 to 79.0
|
PRIMARY outcome
Timeframe: October 2011Population: Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.
Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.
Outcome measures
| Measure |
nCLE System (Stage 2)
n=31 Participants
Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
|
|---|---|
|
Specificity
|
100 percentage of participants
Interval 66.0 to 100.0
|
PRIMARY outcome
Timeframe: October 2011Population: Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.
Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.
Outcome measures
| Measure |
nCLE System (Stage 2)
n=31 Participants
Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
|
|---|---|
|
PPV (Positive Predictive Value)
|
100 percentage of participants
Interval 75.0 to 100.0
|
PRIMARY outcome
Timeframe: October 2011Population: Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.
Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available.
Outcome measures
| Measure |
nCLE System (Stage 2)
n=31 Participants
Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
|
|---|---|
|
NPV (Negative Predictive Value)
|
50 percentage of participants
Interval 26.0 to 74.0
|
SECONDARY outcome
Timeframe: August 2011Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure
Outcome measures
| Measure |
nCLE System (Stage 2)
n=66 Participants
Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
|
|---|---|
|
Overall Complication Rate
|
9 percentage of participants
Interval 3.0 to 19.0
|
Adverse Events
nCLE System
Serious adverse events
| Measure |
nCLE System
n=66 participants at risk
Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
1.5%
1/66 • Patients were contacted one week after procedure by telephone.
|
Other adverse events
| Measure |
nCLE System
n=66 participants at risk
Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
1.5%
1/66 • Patients were contacted one week after procedure by telephone.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/66 • Patients were contacted one week after procedure by telephone.
|
|
Gastrointestinal disorders
Intracystic bleeding
|
4.5%
3/66 • Patients were contacted one week after procedure by telephone.
|
Additional Information
Dr. Vani J.A. Konda
University of Chicago Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place