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.
Distant metastasis, including peritoneal, hepatic, distant lymph node, or other organ metastasis.
Requirement for distal, central, or total pancreatectomy, or another palliative procedure.
Preoperative American Society of Anesthesiologists physical status classification of 4 or higher.
Concurrent malignancy other than the target cancer.
Parallel
Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy
Procedure/SurgeryA pancreaticoduodenectomy performed through a 60- to 80-mm periumbilical single-incision access platform containing three trocars, with one additional 12-mm laparoscopic port. Resection and reconstruction are performed according to the standardized multicenter operative protocol.
Conventional Laparoscopic Pancreaticoduodenectomy
Procedure/SurgeryA conventional laparoscopic pancreaticoduodenectomy performed using five trocar ports, followed by resection and reconstruction according to the standardized multicenter operative protocol.
Overall Survival Rate at 1 Year After Surgery
All-Cause Mortality Within 90 Days After Surgery
Overall Postoperative Complication Rate Within 30 Days
R0 Resection Rate
R0 resection rate, defined as the percentage of subjects without microscopic residual tumor on surgical margins based on final postoperative pathological assessment.
Operative Time
Disease-Free Survival Rate at 1 Year After Surgery
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