RECRUITINGINTERVENTIONAL

Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma.

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years. - Patients scheduled to undergo pancreaticoduodenectomy with planned mesopancreatic excision. - diagnosed by tissue sample (biopsy-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. - your organs (liver, kidneys, etc.) are working well enough based on blood tests (e.g., bilirubin \<1.5x upper limit of normal(ULN), creatinine clearance \>50 mL/min). - willing to sign a consent form. Who Should NOT Join This Trial: - 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 willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

PROCEDURE

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.

Locations (1)

Liver and GIT hospital , Minia University

Minya, Minya Governorate, Egypt