Validation of a Model for Predicting Duodenal Stump Leakage After Gastrectomy

NCT06807372 | Active Not Recruiting

• 1 other identifier: 2024-0856
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of duodenal stump leakage

  Within 30 days after operation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jichao Qin: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Jinhua Central Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 4, 2025
• Study Start: September 11, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

CN (1)