Validation of a Model for Predicting Duodenal Stump Leakage After Gastrectomy

March 8, 2026 updated by: Jichao Qin

A Multicenter Prospective Study of Artificial Intelligence Predicting Duodenal Stump Leakage After Laparoscopic Radical Gastrectomy for Gastric Cancer

This study aims to validate a machine learning model for predicting duodenal stump leakage after laparoscopic radical gastrectomy for gastric cancer.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Gastrectomy is an essential procedure in radical surgery for gastric cancer. Duodenal stump leakage (DSL) is one of the critical short-term complications after distal and total gastrectomy in gastric cancer patients. Identifying patients with high-risk of DSL will assist the surgeons' decision making to give efficient previous intervention, such as a more rigorous operation, placing dual-lumen flushable drainage catheter and decompression tube in afferent loop. Investigators have developed a high-performance machine learning model based on 4070 gastric cancer patients, which showed good discrimination of DSL. Hence, this multi-center prospective study will validate the reliability of this model for predicting DSL in gastric cancer patients who receive laparoscopic distal or total gastrectomy.

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study involves the population of the First Affiliated Hospital of School of Medicine, Zhejiang University, the Second Affiliated Hospital of School of Medicine, Zhejiang University and Jinhua Central Hospital.

Description

Inclusion Criteria:

  1. Aged older than 18 years and younger than 85 years
  2. Primary gastric carcinoma confirmed by preoperative pathology result
  3. Expected curative resection via laparoscopic distal or total gastrectomy and reconstruction via Billroth-II or Roux-en-Y anastomosis
  4. American Society of Anesthesiologists (ASA) class I, II, or III
  5. With full documents of preoperative examinations such as blood test and abdominal CT scanning
  6. Written informed consent

Exclusion Criteria:

  1. Pregnant or breastfeeding women.
  2. Severe mental disorder or language communication disorder.
  3. Other surgical procedures of gastrectomy is performed.
  4. Interrupted of surgery for more than 30 minutes due to any cause.
  5. Malignant tumors with other organs
  6. Performed gastrectomy in the past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of duodenal stump leakage
Time Frame: Within 30 days after operation
Within 30 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jichao Qin

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
Jinhua Central Hospital
Second Affiliated Hospital of Nanchang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 4, 2025

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0856

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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