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

NCT07744087 | Recruiting DMC

• 1 other identifier: NFEC-2026-403
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Duodenal Adenocarcinoma; Distal Cholangiocarcinoma; Ampullary Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Overall Postoperative Complication Rate Within 30 Days

  From surgery through 30 days after surgery

• R0 Resection Rate

  At final postoperative pathological assessment, up to 30 days after surgery

• Operative Time

  During the index surgery

• Disease-Free Survival Rate at 1 Year After Surgery

  From the date of surgery to 1 year after surgery

• Conversion to Open Surgery Rate

  During the index surgery

Study Arms (2)

Modified Single-Incision Plus One-Port Laparoscopic Pancreaticoduodenectomy

EXPERIMENTAL

Procedure: Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy

Conventional Five-Port Laparoscopic Pancreaticoduodenectomy

ACTIVE COMPARATOR

Patients undergo conventional five-port laparoscopic pancreaticoduodenectomy. Standard laparoscopic technique with five abdominal trocars is adopted for pancreaticoduodenectomy and digestive tract reconstruction.

Procedure: Conventional Laparoscopic Pancreaticoduodenectomy

Interventions

Conventional Laparoscopic Pancreaticoduodenectomy PROCEDURE

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

Conventional Five-Port Laparoscopic Pancreaticoduodenectomy

Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy PROCEDURE

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.

Also known as: mSILPD+1

Modified Single-Incision Plus One-Port Laparoscopic Pancreaticoduodenectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (4)

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

Chongqing, Chongqing Municipality, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

The People's Hospital of Jianyang City

Jiancheng, Sichuan, 641400, China

RECRUITING

Central Study Contacts

Chenfenglin Yang

CONTACT

+86 18583065665; 15182546920@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 4, 2026
• Study Start: June 4, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)