Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07232810

Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer

Led by Minia University · Updated on 2025-12-02

90

Participants Needed

1

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63 18 years.
  • Patients scheduled to undergo pancreaticoduodenectomy with planned mesopancreatic excision.
  • Histologically confirmed pancreatic ductal adenocarcinoma of the pancreatic head by endoscopic ultrasound-guided biopsy.
  • Resectable disease according to National Comprehensive Cancer Network guidelines (no distant metastases; no arterial involvement greater than 1806; venous involvement reconstructable).
  • Eastern Cooperative Oncology Group performance status 0 to 2.
  • Adequate organ function, including bilirubin less than 1.5 times the upper limit of normal and creatinine clearance greater than 50 mL/min.
  • Able and willing to provide informed consent.
Not Eligible

You will not qualify if you...

  • Unresectable pancreatic ductal adenocarcinoma.
  • Distant metastases.
  • Periampullary tumors other than pancreatic adenocarcinoma.
  • Prior neoadjuvant chemotherapy or radiotherapy.
  • Active second malignancy.
  • Severe comorbidities that prevent surgery, such as uncontrolled heart disease.
  • Pregnancy or breastfeeding.
  • Prior abdominal radiotherapy.
  • Unable or unwilling to provide informed consent.

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Trial Site Locations

Total: 1 location

1

Liver and GIT hospital , Minia University

Minya, Minya Governorate, Egypt, 61519

Actively Recruiting

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Research Team

S

Saleh K Saleh, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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