Validation of a Model for Predicting Anastomotic Leakage

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT05646290
• Lead Sponsor: Jichao Qin

Brief Summary

This study will validate a machine learning model for predicting anastomotic leakage of esophagogastrostomy and esophagojejunostomy.

Detailed Description

Anastomotic leakage is a fatal complication after total and proximal gastrectomy in gastric cancer patients. Identifying patients with high-risk of AL is important for guiding the surgeons' decision making, such as a more rigorous anastomotic operation， placing a jejunal feeding tube and dual-lumen flushable drainage catheter. We have developed a high-performance machine learning model based on 1660 gastric cancer patients, which showed good discrimination of anastomotic leakage. Hence, this multi-center prospective study will validiate the usability of the model for predicting anastomotic leakage in gastric cancer patients who receive total and proximal gastrectomy.

Study Timeline

• Study Start: 2022-01-06
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-09
• Study First Posted: 2022-12-12
• Primary Completion: 2024-03-15
• Study Completion: 2024-05-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 512

Inclusion Criteria

Inclusion Criteria:

1. Aged older than 18 years and younger than 85 years.
2. Primary gastric adenocarcinoma confirmed by preoperative pathology.
3. Expected curative resection via total or proximal gastrectomy.
4. American Society of Anesthesiologists (ASA) class I, II, or III.
5. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of anastomotic leakage	Within 30 days after operation

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology; 🇨🇳 Wuhan, Hubei, China