RecruitingNot Applicable

Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy

Egypt90 participantsStarted 2026-01-17

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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 .

What they're measuring

Overall Morbidity (Clavien-Dindo Classification)

Timeframe: 90 days postoperative.

Trial details

NCT IDNCT07328607

SponsorMinia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-15

Contact for this trial

Saleh K Saleh, MD

01201765401 salehkhairy@mu.edu.eg