Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinia University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Emergency surgery.

Previous pancreatic surgery.

Concurrent major abdominal procedures .

ASA classification IV or higher.

Trial design

Treatments tested in this trial

  • Open Pancreaticoduodenectomy
  • Laparoscopic Pancreaticoduodenectomy

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators