NCT07232810 Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer
| NCT ID | NCT07232810 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Minia University |
| Condition | Pancreatic Head Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-12-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Saleh K Saleh, MD
PRINCIPAL INVESTIGATOR
Minia University
Frequently Asked Questions
Who can join the NCT07232810 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pancreatic Head Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07232810 currently recruiting?
Yes, NCT07232810 is actively recruiting participants. Contact the research team at salehkhairy@mu.edu.eg for enrollment information.
Where is the NCT07232810 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07232810 clinical trial?
NCT07232810 is sponsored by Minia University. The principal investigator is Saleh K Saleh, MD at Minia University. The trial plans to enroll 90 participants.
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