RecruitingNot ApplicableNCT07148830

Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma.

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

Sponsor

Minia University

Enrollment

100 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Pancreatic Ductal Adenocarcinoma

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria9

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.

Interventions

PROCEDURETotal 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.