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Clinical Trials in Egypt / NCT07148830
Recruiting Not applicable

Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma.

NCT07148830 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2024-04-01
Last updated
2026-09-11

Condition(s) studied

Pancreatic Ductal AdenocarcinomaPancreatic Cancer

Investigational drug(s) / intervention(s)

Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)

Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy): * 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) is an aggressive cancer with high rates of local recurrence and distant metastasis.

Recent evidence suggests that mesopancreatic excision (TMpE) may improve R0 resection rates, reduce local recurrence, and enhance overall survival compared to standard pancreatoduodenectomy. However, most existing studies are retrospective with heterogeneous patient populations and surgical techniques.

This prospective study aims to evaluate the impact of mesopancreatic excision, a surgical technique involving the meticulous removal of retroperitoneal tissue surrounding major peripancreatic vessels, on local disease control and overall survival in patients undergoing pancreaticoduodenectomy for resectable PDAC. The study will also assess R0 resection rates, disease-free survival, recurrence patterns and perioperative outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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: * Borderline resectable or unresectable 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)

Trial sites (1)

FacilityCityRegionStatus
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 NCT07148830 on ClinicalTrials.gov ↗ ← All trials in Egypt