Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer

NCT07232810 · tracked via the Priya Life Science Egypt tracker

Sponsor

Minia University

Phase

Not applicable

Started

2025-12-01

Last updated

2025-12-02

Condition(s) studied

Pancreatic Head CancerPancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

Total Mesopancreas Excision (TMpE)

Total 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Age ≥18 years. * Patients scheduled to undergo pancreaticoduodenectomy with planned mesopancreatic excision. * Histologically confirmed PDAC of the pancreatic head (via endoscopic ultrasound-guided biopsy). * Resectable disease per National Comprehensive Cancer Network(NCCN) guidelines (no distant metastases, no arterial involvement \>180°, venous involvement reconstructable). * Eastern Cooperative Oncology Group(ECOG) performance status 0-2. * Adequate organ function (e.g., bilirubin \<1.5x upper limit of normal(ULN), creatinine clearance \>50 mL/min). * Informed consent. Exclusion Criteria: * Irresectable PDAC. * Distant metastases. * Periampullary tumors other than pancreatic adenocarcinoma * Prior neoadjuvant chemotherapy or radiotherapy (to isolate TMpE effect;may be amended for subgroups). * Active second malignancy. * Severe comorbidities precluding surgery (e.g., uncontrolled cardiac disease). * Pregnancy or lactation. * Patients who have received prior radiotherapy to the abdomen. * Patients unwilling or unable to provide informed consent.

Primary outcome measure(s)

Disease-Free Survival (DFS) — 24 months post-surgery
Time from surgery to first evidence of local recurrence, distant metastases, or death from any cause, whichever occurs first.

Trial sites (1)

Facility	City	Region	Status
Liver and GIT hospital , Minia University	Minya	Minya Governorate	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07232810 on ClinicalTrials.gov ↗ ← All trials in Egypt