Total mesopancreas removal to improve outcomes after pancreatic head surgery

Prognostic Outcomes of Total Mesopancreas Excision During Pancreaticoduodenectomy for Pancreatic Head Cancer

This project will try a standardized total mesopancreas excision during pancreaticoduodenectomy to see if it reduces recurrence and increases disease-free survival in adults with resectable pancreatic head cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Minia University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Minya, Minya Governorate)
• Trial ID: NCT07232810 on ClinicalTrials.gov

What this trial studies

Pancreatic ductal adenocarcinoma has high rates of local recurrence after standard pancreaticoduodenectomy, in part from residual retroperitoneal tissues around peripancreatic vessels. Total mesopancreas excision (TMpE) is a surgical technique designed to remove that tissue en bloc to increase R0 resection rates. This single-arm prospective study will apply a standardized TMpE technique in 90 consecutive patients with resectable pancreatic head cancer and follow them for disease-free survival at 24 months as the primary endpoint. Secondary endpoints include overall survival, R0 resection rates, recurrence patterns, and perioperative morbidity.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed, resectable pancreatic ductal adenocarcinoma of the pancreatic head, ECOG 0–2, adequate organ function, and planned pancreaticoduodenectomy without prior neoadjuvant therapy are ideal candidates.

Not a fit: Patients with unresectable disease, distant metastases, major arterial involvement, prior neoadjuvant therapy, or severe comorbidities that preclude surgery are unlikely to benefit from this surgical approach.

Why it matters

Potential benefit: If successful, TMpE could increase complete (R0) resections and lower local recurrence, leading to longer disease-free intervals for patients.

How similar studies have performed: Retrospective series and meta-analyses have reported higher R0 rates and reduced locoregional recurrence with TMpE, but prospective data are limited and no large randomized trials have confirmed benefit.

Eligibility criteria

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:

* Irresectable 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 this trial is running

Minya, Minya Governorate

• Liver and GIT hospital , Minia University — Minya, Minya Governorate, Egypt (RECRUITING)

Study contacts

• Principal investigator: Saleh K Saleh, MD — Minia University
• Study coordinator: Saleh K Saleh, MD

Conditions: Pancreatic Head Cancer, Pancreatic Ductal Adenocarcinoma, Total Mesopancreas Excision, TMpE, Pancreaticoduodenectomy, Pancreatic Cancer, DFS, R0 Resection