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Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy
RECRUITINGN/ASponsored by Minia University
Actively Recruiting
PhaseN/A
SponsorMinia University
Started2026-01-17
Est. completion2028-01-15
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07328607
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
Age: 18 Years – 75 YearsHealthy volunteers accepted
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 .
Conditions6
Ampullary CarcinomaCancerDistal CholangiocarcinomaDuodenal AdenocarcinomaPancreatic Ductal AdenocarcinomaPancreatic Neuroendocrine Tumor
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Actively Recruiting
PhaseN/A
SponsorMinia University
Started2026-01-17
Est. completion2028-01-15
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07328607