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

NCT07744087 · tracked via the Priya Life Science China tracker

Sponsor

Nanfang Hospital, Southern Medical University

Phase

Not applicable

Started

2026-06-04

Last updated

2026-08-04

Condition(s) studied

Ampullary CarcinomaDuodenal AdenocarcinomaDistal Cholangiocarcinoma

Investigational drug(s) / intervention(s)

Modified Single Incision plus one-port Laparoscopic PancreaticoduodenectomyConventional Laparoscopic Pancreaticoduodenectomy

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.

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Pregnancy or breastfeeding. * Severe psychiatric disorder that would interfere with study participation. * Receipt of neoadjuvant chemotherapy or radiotherapy before surgery. * Vascular invasion requiring vascular resection, as determined by the multidisciplinary team based on preoperative abdominal imaging. * Body mass index greater than 35 kg/m². * Participation in another clinical trial within the previous 3 months.

Primary outcome measure(s)

Overall Survival Rate at 1 Year After Surgery — From the date of surgery to 1 year after surgery
All-Cause Mortality Within 90 Days After Surgery — From surgery through 90 days after surgery

Trial sites (4)

Facility	City	Region	Status
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)	Chongqing	Chongqing Municipality	Recruiting
Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	Recruiting
West China Hospital, Sichuan University	Chengdu	Sichuan	Recruiting
The People's Hospital of Jianyang City	Jiancheng	Sichuan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07744087 on ClinicalTrials.gov ↗ ← All trials in China