Validation of a Model for Predicting Duodenal Stump Leakage After Gastrectomy

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06807372

Enrollment

1200

Registered

2025-02-04

Start date

2024-09-11

Completion date

2026-12-01

Last updated

2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancers

Keywords

artificial intelligence, gastric cancer, duodenal stump leakage, radical gastrectomy

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of duodenal stump leakage	Within 30 days after operation

Countries

China

Outcome results