Validation of a Model for Predicting Anastomotic Leakage

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646290
• Other study ID #: TJ-IRB20211255
• Status: Recruiting
• Start date: January 6, 2022
• Est. completion date: April 6, 2024

Study information

• Verified date: December 2022
• Source: Tongji Hospital
• Contact: Jichao Qin, M.D./Ph.D
• Phone: +86-27-83665316
• Email: jcqin[@]tjh.thmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 880
• Est. completion date: April 6, 2024
• Est. primary completion date: January 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Gastric Cancer

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jichao Qin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of anastomotic leakage		Within 30 days after operation