Total mesopancreas removal to improve outcomes after pancreatic head surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.