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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Resection
• Intervention / Treatment: Other: Dye

Detailed Description

Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters) The prognosis and life expectancy for people with pancreatic cancer remain very low (3rd cause of mortality among all cancer). Surgical resection is the only curative treatment, whenever possible. Nevertheless, major pancreatectomies lead to high postoperative morbidity rate, in particular up to 30% fistula rate. In case of parenchyma-sparing procedures, this rate is even higher, up to 40%.

One of the reasons of these high rates might be explained by the fact that pancreatic transections are currently not performed following pancreatic segmentation. If possible, resection following vascular segmentation would prevent necrosis of the transection, resection following lymphatic segmentation would improve the lymph-node dissection, and resection following pancreatic-duct segmentation would prevent leakage from pancreatic duct stump. Nevertheless, no precise "anatomic" pancreatic segmentation currently exists.

On the other hand, the lymphatic system of the pancreas is highly complex, but the quality of the lymphadenectomy during pancreatectomy is essential since the recurrences almost always occur on the lymphatic transections. A better knowledge of the peri-pancreatic lymphatic vessels is still required.

The aim of this study is to demonstrate the existence of independent pancreatic segments, following the lymphatic drainage of the gland.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yohann RENARD; Phone Number: 0033 3 26 78 71 23; Email: yrenard@chu-reims.fr

Study Locations

• France
  • Reims, France, 51092
    • Recruiting
    • CHU Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: patients operated on for pancreatic resection; All consecutive patients operated on for pancreatic resection

Other: Dye; 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.; Other Names: The dye will be the blue patent, widely used for the detection of the sentinel lymph node for breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CHU de Reims

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Anticipated): October 22, 2020
• Study Completion (Anticipated): October 22, 2020

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PO18091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No