NCT07328607 Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy
| NCT ID | NCT07328607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Minia University |
| Condition | Pancreatic Ductal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-01-17 |
| Primary Completion | 2028-01-15 |
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 2026-01-17 with a primary completion date of 2028-01-15.
⚠ 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
This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years. * Histologically confirmed or clinically suspected lesions of: Pancreatic head adenocarcinoma, Ampullary carcinoma, Distal cholangiocarcinoma, Duodenal adenocarcinoma, Pancreatic neuroendocrine tumors, or Intraductal Papillary Mucinous Neoplasm(IPMN) . * Resectable disease based on preoperative imaging. * Eastern Cooperative Oncology Group(ECOG) performance status 0-2. * American Society of Anesthesiologists(ASA )classification I-III. * Patients able to provide informed consent. Exclusion Criteria: * Emergency surgery. * Previous pancreatic surgery. * Concurrent major abdominal procedures . * ASA classification IV or higher. * Metastatic disease identified preoperatively. * Locally advanced unresectable disease. * Active infection or sepsis at time of surgery. * Severe cardiopulmonary comorbidities precluding major surgery. * Pregnancy. * Procedures requiring Total Pancreatectomy, Distal Pancreatectomy, or Enucleation .
Contact & Investigator
Saleh K Saleh, MD
PRINCIPAL INVESTIGATOR
Minia University
Frequently Asked Questions
Who can join the NCT07328607 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Ductal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07328607 currently recruiting?
Yes, NCT07328607 is actively recruiting participants. Contact the research team at salehkhairy@mu.edu.eg for enrollment information.
Where is the NCT07328607 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07328607 clinical trial?
NCT07328607 is sponsored by Minia University. The principal investigator is Saleh K Saleh, MD at Minia University. The trial plans to enroll 90 participants.