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WithdrawnNCT03348319Updated Aug 23, 2024

Is There a Pancreatic Segmentation Based on the Pancreatic Duct Branching?

An observational study in Pancreas, sponsored by CHU de Reims. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by CHU de Reims · Observational

Why this study was withdrawn
logistics problems
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Pancreas
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

exclusion criteria :

  • Cadavers not usable due to learning necessity, to failure of conservation, dissection difficulties.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Cadaver organs

    Other: radiation

Interventions

  • Otherradiation

    Scanning cadaver organs

05

What researchers measure

Primary outcomes

  1. Size of the ducts

    The anatomic specimens will be scanned. The images will be analysed

    Time frame: baseline

  2. Number of branching

    The anatomic specimens will be scanned. The images will be analysed

    Time frame: baseline

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03348319
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Nov 20, 2017
Start date
Oct 22, 2018
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021
Last update
Aug 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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