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Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy

RecruitingNAAges 18 Years - 75 YearsAllMinia University
NCT07328607 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 .
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What it tests

  • Open Pancreaticoduodenectomy
  • Laparoscopic Pancreaticoduodenectomy
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Where

1 site
Liver and GIT hospital , Minia University
Minya, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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