Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy
Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial
Minia University
90 participants
Jan 17, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria10
- 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 .
Interventions
Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.
Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.
Locations(1)
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NCT07328607