Endoscopic Drainage of Collections After Pancreatic Surgery (COLLECTOR)

September 16, 2016 updated by: Institut Paoli-Calmettes

The pancreatic surgery causing some pancreatic collections. And in a number of case, this surgery can require a surgical resumption, a percutaneous drainage or an endoscopic drainage.

The endoscopic care of the treatment of pancreatic collections post-surgery is not yet standardized.

After failure of the medical treatment, the drainage of collections by echo-endoscopy was described.

There are not much series on this specific subject. Only 2 series contain more than 20 patients with 31 patients for the most important.

The timing and the technical choice of the endoscopic treatment as well as the long-term follow-up are not clear.

The purpose of this study is to estimate the success and the complications of the endoscopic drainage by echo-endoscopy according to the techniques of drainage and the timing of the endoscopic treatment.

The not estimated long-term follow-up will be also considered.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient having a pancreatic surgery complicated with a post-operative collection drained endoscopically

Description

Inclusion Criteria:

  • Age > 18 years
  • Patient having a pancreatic surgery complicated with a post-operative collection drained endoscopically

Exclusion Criteria:

  • Contraindication surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Long-term evaluation of the risk of relapse
Time Frame: Up to 6 month
Up to 6 month
Timing of endoscopic drainage
Time Frame: Up to 3 month
Up to 3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Immediate efficiency
Time Frame: Immediate post operative intervention
Immediate post operative intervention

Other Outcome Measures

Outcome Measure
Time Frame
Post surgery complications
Time Frame: Up to 1 month
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: CAILLOL Fabrice, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Estimate)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 16, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • COLLECTOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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