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RECRUITING
NCT07744087
NA

Modified Single-Incision Plus One-Port Versus Conventional Five-Port Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: Modified "Single-Incision Plus One "Versus Conventional "Five-Port" Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas: Study Protocol for A Multicentre Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

232

Start Date

2026-06-04

Completion Date

2029-12

Last Updated

2026-08-04

Healthy Volunteers

No

Interventions

PROCEDURE

Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy

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.

PROCEDURE

Conventional Laparoscopic Pancreaticoduodenectomy

A conventional laparoscopic pancreaticoduodenectomy performed using five trocar ports, followed by resection and reconstruction according to the standardized multicenter operative protocol.

Locations (4)

The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

Chongqing, Chongqing Municipality, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

The People's Hospital of Jianyang City

Jiancheng, Sichuan, China