Validation of a Model for Predicting Anastomotic Leakage

Validation of a Machine Learning Model for Predicting Anastomotic Leakage of Esophagogastrostomy and Esophagojejunostomy: A Multicenter Prospective Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05646290

Enrollment

512

Registered

2022-12-12

Start date

2022-01-06

Completion date

2024-05-06

Last updated

2024-11-21

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

Conditions

Gastric Cancer

Keywords

machine learning, anastomotic leakage, total and proximal gastrectomy

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.

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

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

Design outcomes

Primary

Measure	Time frame
Incidence of anastomotic leakage	Within 30 days after operation

Countries

China

Outcome results