Status:
RECRUITING
Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma.
Lead Sponsor:
Minia University
Conditions:
Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer with high rates of local recurrence and distant metastasis. Recent evidence suggests that mesopancreatic excision (TMpE) may improve R0...
Detailed Description
Pancreatic duct adenocarcinoma (PDAC) is one of the most aggressive malignancies, with a 5-year overall survival rate of approximately 20-25% even after curative resection. Standard pancreaticoduodene...
Eligibility Criteria
Inclusion
- 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
- Borderline resectable or unresectable 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07148830
Start Date
April 1 2024
End Date
May 1 2027
Last Update
August 29 2025
Active Locations (1)
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1
Liver and GIT hospital , Minia University
Minya, Minya Governorate, Egypt, 61519