Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07744087

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ampullary Carcinoma Distal Cholangiocarcinoma Duodenal Adenocarcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital), Chongqing, Chongqing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: mSILPD+1

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.

Primary outcomes

  1. Overall Survival Rate at 1 Year After Surgery

    Time frame: From the date of surgery to 1 year after surgery

  2. All-Cause Mortality Within 90 Days After Surgery

    Time frame: From surgery through 90 days after surgery

Secondary outcomes

  1. Overall Postoperative Complication Rate Within 30 Days

    Time frame: From surgery through 30 days after surgery

  2. R0 Resection Rate

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

    R0 resection rate, defined as the percentage of subjects without microscopic residual tumor on surgical margins based on final postoperative pathological assessment.

  3. Operative Time

    Time frame: During the index surgery

  4. Disease-Free Survival Rate at 1 Year After Surgery

    Time frame: From the date of surgery to 1 year after surgery

  5. Conversion to Open Surgery Rate

    Time frame: During the index surgery

  6. Postoperative Length of Hospital Stay

    Time frame: From surgery to hospital discharge, up to 30 days after surgery

    Duration of hospitalization from the date of surgery until hospital discharge, reported as number of days.

Study contacts

Contact information is provided by the study sponsor or research team.

Chenfenglin Yang

CONTACT

[email protected]

+86 18583065665

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.