Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer
Recruiting · NCT07232810 · 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) has poor prognosis due to high recurrence rates after standard pancreaticoduodenectomy (PD). The concept of Total Mesopancreas Excision (TMpE), analogous to total mesorectal excision, aims to improve oncological outcomes by achieving higher R0 resection rates through the comprehensive removal of retroperitoneal connective tissue surrounding major peripancreatic vessels. This single arm prospective study will evaluate the prognostic outcomes, primarily Disease- Free Survival (DFS) at 24 months, of a standardized TMpE technique performed during pancreaticoduodenectomy for resectable pancreatic head cancer. Secondary objectives include assessing Overall Survival (OS), R0 resection rates, recurrence patterns, and perioperative outcomes in 90 consecutive patients.
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
- 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 is running
1 location listed.
- Liver and GIT hospital , Minia University - Minya, Minya Governorate, Egypt