Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMinia University
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Irresectable PDAC.
Distant metastases.
Periampullary tumors other than pancreatic adenocarcinoma
Prior neoadjuvant chemotherapy or radiotherapy (to isolate TMpE effect;may be amended for subgroups).
Trial design
Treatments tested in this trial
- Total Mesopancreas Excision (TMpE)
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov