- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03348319
Is There a Pancreatic Segmentation Based on the Pancreatic Duct Branching?
August 21, 2024 updated by: CHU de Reims
The Pancreas and the Bilio-pancreatic Junction: Is There a Pancreatic Segmentation Based on the Pancreatic Duct Branching?
Limited pancreatic resections are increasingly performed, but the rate of postoperative fistula is higher than after classical resections.
Pancreatic segmentation, anatomically and radiologically identifiable, may theoretically help the surgeon removing selected anatomical portions with their own segmental pancreatic duct and thus might decrease the postoperative fistula rate.
Current pancreatic segmentation theories do not enable defining anatomical-surgical pancreatic segments.
To our knowledge, no study has tried to describe pancreatic segmentation from the divisions of the pancreatic ducts to date.
Hence, we hypothesize to explore the possibility of pancreatic segmentation following pancreatic ducts, using extensive reconstructions of pancreatic duct using micro-scanner on injected human pancreas.
Study Overview
Detailed Description
- In a first step, the injection technique will be developed (dilution, stability, hardening of the contrast mixture).
- In a second step, we will inject the mixture in human pancreas: into the duct tree, the vein and arteries. After hardening, the human pancreas will be removed from cadavers following the organ donation technique. The anatomic specimens will be scanned in the laboratory UMR CNRS 7369 MEDyC, Reims (Pr X. MAQUART, Dr J. DEVY).
- The images obtained (Dicom format) are very big in term of file size. Analysis of the images will be performed using a supercomputer of the laboratory CReSTIC - ROMEO EA 3804, Reims (Dr A. RENARD, Pr M. KRAJEKI). 3D reconstructions will be performed.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Reims, France, 51092
- Recruiting
- CHU Reims
-
-
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
Yes
Sampling Method
Non-Probability Sample
Study Population
consecutive cadavers donated to the Department of Anatomy, Faculty of Medicine and University Hospital, Champagne-Ardenne University
Description
inclusion criteria :
- All consecutive cadavers donated to the Department of Anatomy, Faculty of Medicine and University Hospital, Champagne-Ardenne University for anatomical education and research will be studied. These cadavers will be studied following all the ethical rules of work on cadaver material in our institution.
exclusion criteria :
- Cadavers not usable due to learning necessity, to failure of conservation, dissection difficulties.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cadaver organs
|
Scanning cadaver organs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Size of the ducts
Time Frame: baseline
|
The anatomic specimens will be scanned.
The images will be analysed
|
baseline
|
|
Number of branching
Time Frame: baseline
|
The anatomic specimens will be scanned.
The images will be analysed
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
October 22, 2018
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
October 20, 2017
First Submitted That Met QC Criteria
November 16, 2017
First Posted (Actual)
November 20, 2017
Study Record Updates
Last Update Posted (Actual)
August 23, 2024
Last Update Submitted That Met QC Criteria
August 21, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- PA16146*
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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