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NCT07232810Recruiting

Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer

Prognostic Outcomes of Total Mesopancreas Excision During Pancreaticoduodenectomy for Pancreatic Head Cancer

Source: ClinicalTrials.gov · Last updated 2 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
13 Nov 2025
Start date
1 Dec 2025
Primary completion date
1 Dec 2027
Lead sponsor
Minia University
NCT number
NCT07232810

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 1 Dec 2025 to the primary completion date, 1 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior neoadjuvant chemotherapy or radiotherapy (to isolate TMpE effect;may be amended for subgroups).
  • Patients who have received prior radiotherapy to the abdomen.

Other illness

  • Active second malignancy.
  • Severe comorbidities precluding surgery (e.g., uncontrolled cardiac disease).

Other

  • Irresectable PDAC.
  • Distant metastases.
  • Periampullary tumors other than pancreatic adenocarcinoma
  • Pregnancy or lactation.
  • Patients unwilling or unable to provide informed consent.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Liver and GIT hospital , Minia University
Coordinator of this site? Confirm its status
MinyaEgyptRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.