Comparing Safety and Outcomes of Laparoscopic Versus Open Pancreaticoduodenectomy in Adults with Pancreatic or Periampullary Tumors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of laparoscopic pancreaticoduodenectomy LPD compared to the traditional open pancreaticoduodenectomy OPD in adults with pancreatic or periampullary lesions. This prospective, randomized controlled trial aims to determine the morbimortality differences between these two surgical approaches, focusing on outcomes in patients with pancreatic ductal adenocarcinoma, ampullary carcinoma, distal cholangiocarcinoma, duodenal adenocarcinoma, and pancreatic neuroendocrine tumors. In this study, 90 eligible patients will be randomly assigned to receive either the standard open pancreaticoduodenectomy through a bilateral subcostal incision or the total laparoscopic pancreaticoduodenectomy using a standardized six-port technique. The laparoscopic procedure involves a minimally invasive Whipple operation with six trocars and specimen extraction via a Pfannenstiel incision. Both approaches include lymphadenectomy and reconstruction. The study follows CONSORT guidelines and uses a prospectively maintained database. Participants will be monitored for overall morbidity using the Clavien-Dindo Classification at 90 days after surgery as the primary outcome. Secondary outcomes include lymph node harvest, resection margin status, operative time, blood loss, length of hospital stay, and readmissions. Assessments occur intraoperatively and postoperatively up to 90 days. The trial ensures careful evaluation of recovery and oncologic results in adult patients aged 18 to 75 years with resectable disease.

Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy