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