Per-operative Exploration of the Peri-pancreatic Lymphatic Pathways During Pancreatic Surgical Resection

NCT03597230 | Unknown

• 1 other identifier: PO18091
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) Pancreatic cancer has a poor prognosis. Surgical resection is the only curative treatment. Major pancreatectomies lead to high postoperative morbidity rate, up to 30%. For some tumors, limited resection are increasedly performed, but the rate of pancreatic fistula is even higher, up to 40%. No precise "anatomic" pancreatic segmentation currently exists. If such segmentation is described, pancreatic resections, major of minor, may have better outcomes. The aim of this study is to demonstrate the existence of independent pancreatic segments, following the lymphatic drainage of the gland.

Conditions

Pancreatic Resection

Outcome Measures

Primary Outcomes (1)

• Lymph node areas colored by the diffusion of the blue patent

  At the beginning of the surgical procedure, 1 ml of blue patent will be injected in the normal remaining part of the pancreas. The diffusion of the dye among all lymph node areas will be noticed by the surgeon.

  3 minutes after the injection

Study Arms (1)

patients operated on for pancreatic resection

EXPERIMENTAL

All consecutive patients operated on for pancreatic resection

Other: Dye

Interventions

Dye OTHER

Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study and/or among similar interventions At the beginning of the surgical procedure, 1 ml of blue patent will be injected in the normal remaining part of the pancreas. The diffusion of the dye among all lymph node areas will be noticed by the surgeon.

Also known as: The dye will be the blue patent, widely used for the detection of the sentinel lymph node for breast cancer

patients operated on for pancreatic resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patient operated on for pancreatic resection
• Patients consenting the protocol after clear and loyal explanations

You may not qualify if:

• history of first abdominal surgery in the upper part
• Patients with peritoneal carcinomatosis

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

Related Publications (1)

• Renard Y, Perrenot C, Labrousse M, Avisse C, Rhaiem R, Piardi T, Braun M, Perez M. Exploration of peripancreatic lymphatic pathways in a live porcine model. Ann Anat. 2019 Sep;225:57-64. doi: 10.1016/j.aanat.2019.06.003. Epub 2019 Jul 5.

  PMID: 31284072 DERIVED

MeSH Terms

Interventions

Coloring Agents

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Central Study Contacts

Yohann RENARD

CONTACT

3 26 78 71 23; yrenard@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 24, 2018
• Study Start: October 22, 2018
• Primary Completion: October 22, 2020
• Study Completion: October 22, 2020
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

FR (1)