RecruitingNot ApplicableNCT07232810

Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer

Prognostic Outcomes of Total Mesopancreas Excision During Pancreaticoduodenectomy for Pancreatic Head Cancer

Sponsor

Minia University

Enrollment

90 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma Pancreatic Head Cancer

Summary

Pancreatic ductal adenocarcinoma (PDAC) has poor prognosis due to high recurrence rates after standard pancreaticoduodenectomy (PD). The concept of Total Mesopancreas Excision (TMpE), analogous to total mesorectal excision, aims to improve oncological outcomes by achieving higher R0 resection rates through the comprehensive removal of retroperitoneal connective tissue surrounding major peripancreatic vessels. This single arm prospective study will evaluate the prognostic outcomes, primarily Disease- Free Survival (DFS) at 24 months, of a standardized TMpE technique performed during pancreaticoduodenectomy for resectable pancreatic head cancer. Secondary objectives include assessing Overall Survival (OS), R0 resection rates, recurrence patterns, and perioperative outcomes in 90 consecutive patients.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a more extensive surgical technique called total mesopancreas excision — removing extra tissue around the pancreas — improves survival and reduces cancer recurrence in people having surgery (a Whipple procedure) for pancreatic head cancer. **You may be eligible if...** - You are 18 or older - You have pancreatic ductal adenocarcinoma of the head of the pancreas confirmed by biopsy - Your tumor is surgically removable with no distant spread or major blood vessel involvement - You are in reasonably good health (ECOG score 0–2) - Your kidneys and liver are functioning adequately **You may NOT be eligible if...** - Your tumor cannot be surgically removed - Your cancer has spread to other parts of the body - You have a non-pancreatic cancer near the bile duct area - You have already received chemotherapy or radiation before surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETotal Mesopancreas Excision (TMpE)

All patients undergo pancreaticoduodenectomy with total mesopancreatic excision (TMpE) and Adjuvant chemotherapy. -Meticulous dissection and en bloc removal of the fatty tissue and perineural lymphatic layer located between the head of the pancreas and the superior mesenteric vessels (superior mesenteric artery and portal vein) and the celiac axis, performed during pancreaticoduodenectomy.