Effect of Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma on Local Disease Control and Survival.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Liver and GIT hospital , Minia University
RECRUITING
Minya
Contact Information
Primary
Saleh K Saleh, MD
salehkhairy@mu.edu.eg
01201765401
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 100
Treatments
Experimental: Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)
En bloc removal of the fatty tissue and perineural lymphatic layer located between the head of the pancreas and the superior mesenteric vessels and the celiac axis, performed during pancreaticoduodenectomy.
Sponsors
Leads: Minia University

This content was sourced from clinicaltrials.gov