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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03348319
Other study ID # PA16146
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 22, 2018
Est. completion date April 1, 2021

Study information

Verified date April 2019
Source CHU de Reims
Contact Yohann RENARD
Phone 326787123
Email yrenard@chu-reims.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date April 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
radiation
Scanning cadaver organs

Locations

Country Name City State
France Chu Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Size of the ducts The anatomic specimens will be scanned. The images will be analysed baseline
Primary Number of branching The anatomic specimens will be scanned. The images will be analysed baseline
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