Modified Single-Incision Plus One Versus Conventional Five-Port Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas: Study Protocol for A Multicentre Randomised Controlled Trial
This multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic periampullary carcinoma who are candidates for pancreaticoduodenectomy. A total of 232 participants will be randomly assigned in a 1:1 ratio. Outcome assessors who adjudicate complications and interpret imaging will be masked to treatment assignment. The primary outcomes are all-cause mortality within 90 days after surgery and overall survival at 1 year after surgery. Secondary outcomes will assess postoperative complications, surgical performance, postoperative recovery, disease-free survival, quality of life, and health-care costs.
• Age 18 years or older and younger than 75 years.
• Histopathologically confirmed non-pancreatic periampullary carcinoma, or a high clinical suspicion of non-pancreatic periampullary carcinoma when preoperative pathological confirmation is unavailable.
• Determined by preoperative multidisciplinary team evaluation to require pancreaticoduodenectomy.
• Able to understand and comply with study procedures.
• Able and willing to provide written informed consent before any study-specific screening procedure.
• Expected to benefit from therapeutic pancreaticoduodenectomy according to applicable clinical guidelines.