Mesopancreas removal during Whipple surgery for pancreatic head cancer
Effect of Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma on Local Disease Control and Survival.
This will test whether adding mesopancreatic excision to the Whipple operation helps people with resectable pancreatic head cancer have fewer local recurrences and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Minya, Minya Governorate) |
| Trial ID | NCT07148830 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center surgical study enrolling adults with resectable pancreatic ductal adenocarcinoma of the pancreatic head who are planned for pancreaticoduodenectomy. Participants will undergo total mesopancreatic excision (TMpE) as part of their Whipple procedure, with standardized operative technique and detailed pathological assessment. The study will track perioperative outcomes, R0 resection rates, patterns of recurrence, disease-free survival, and overall survival. Results will be compared to historical benchmarks to determine the impact of TMpE on local control and long-term outcomes.
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 are the intended candidates.
Not a fit: Patients with metastatic, borderline or unresectable disease, non-pancreatic periampullary tumors, 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, reduce local recurrence, and potentially improve long-term survival for patients with resectable pancreatic head cancer.
How similar studies have performed: Retrospective series and meta-analyses have reported higher R0 rates and reduced locoregional recurrence with TMpE, but prospective randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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: * 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 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
- Email: salehkhairy@mu.edu.eg
- Phone: 01201765401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.