Laparoscopic versus open pancreaticoduodenectomy outcomes
Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial
This trial will test whether laparoscopic (keyhole) pancreaticoduodenectomy leads to fewer complications and faster recovery than open pancreaticoduodenectomy in adults with resectable pancreatic or periampullary tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya, Minya Governorate) |
| Trial ID | NCT07328607 on ClinicalTrials.gov |
What this trial studies
This monocentric, prospective, randomized controlled trial will enroll 90 adults with resectable pancreatic head or periampullary lesions and randomize them 1:1 to laparoscopic pancreaticoduodenectomy (LPD) or open pancreaticoduodenectomy (OPD). The primary outcome is overall morbidity measured by the Clavien–Dindo classification at 90 days postoperatively. Secondary outcomes include oncologic measures (lymph node harvest, margin status), perioperative metrics (operative time, blood loss), and postoperative recovery (length of stay, readmissions). The trial uses a prospectively maintained database and follows CONSORT reporting standards.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) with resectable pancreatic or periampullary tumors who are fit for major surgery (ECOG 0–2, ASA I–III) and can provide informed consent.
Not a fit: Patients with metastatic or locally unresectable disease, prior pancreatic surgery, emergency indications, severe cardiopulmonary comorbidity (ASA IV+), or who require different pancreatic procedures are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the laparoscopic approach could lower complication rates and shorten recovery time compared with the open approach.
How similar studies have performed: Previous cohort studies and some randomized data have suggested LPD can be feasible with comparable oncologic results, but randomized evidence is limited and outcomes across trials have been mixed.
Eligibility criteria
Show full inclusion / exclusion 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 .
Where this trial is running
Minya, Minya Governorate
- Liver and GIT hospital , Minia University — Minya, Minya Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Saleh K Saleh, MD — Minia University
- Study coordinator: Saleh K Saleh, MD
- Email: salehkhairy@mu.edu.eg
- Phone: 01201765401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.