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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
232
A 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.
A conventional laparoscopic pancreaticoduodenectomy performed using five trocar ports, followed by resection and reconstruction according to the standardized multicenter operative protocol.
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, Chongqing Municipality, China
RECRUITINGNanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGWest China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGThe People's Hospital of Jianyang City
Jiancheng, Sichuan, China
RECRUITINGOverall Survival Rate at 1 Year After Surgery
Time frame: From the date of surgery to 1 year after surgery
All-Cause Mortality Within 90 Days After Surgery
Time frame: From surgery through 90 days after surgery
Overall Postoperative Complication Rate Within 30 Days
Time frame: From surgery through 30 days after surgery
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.
Time frame: At final postoperative pathological assessment, up to 30 days after surgery
Operative Time
Time frame: During the index surgery
Disease-Free Survival Rate at 1 Year After Surgery
Time frame: From the date of surgery to 1 year after surgery
Conversion to Open Surgery Rate
Time frame: During the index surgery
Postoperative Length of Hospital Stay
Duration of hospitalization from the date of surgery until hospital discharge, reported as number of days.
Time frame: From surgery to hospital discharge, up to 30 days after surgery
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