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NCT Number: NCT06807372

Validation of a Model for Predicting Duodenal Stump Leakage After Gastrectomy

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Incidence of duodenal stump leakage

    Time frame: Within 30 days after operation

Sponsors and collaborators

Lead sponsor

Jichao Qin

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2025
Registry last updated
Mar 10, 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.

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