Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma.
Recruiting · NCT07148830 · Interventional (participants receive a specific treatment) · Lead sponsor: Minia University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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.
Where it is running
1 location listed.
- Liver and GIT hospital , Minia University - Minya, Minya Governorate, Egypt