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

Pancreatic Resection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03597230
• Other study ID #: PO18091
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: October 22, 2020

Study information

• Verified date: December 2019
• Source: CHU de Reims
• Contact: Yohann RENARD
• Phone: 3 26 78 71 23
• Email: yrenard[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 22, 2020
• Est. primary completion date: October 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Resection

Intervention

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.

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	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