- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05646290
Validation of a Model for Predicting Anastomotic Leakage
December 9, 2022 updated by: Jichao Qin
Validation of a Machine Learning Model for Predicting Anastomotic Leakage of Esophagogastrostomy and Esophagojejunostomy: A Multicenter Prospective Study
This study will validate a machine learning model for predicting anastomotic leakage of esophagogastrostomy and esophagojejunostomy.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
880
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jichao Qin, M.D./Ph.D
- Phone Number: +86-27-83665316
- Email: jcqin@tjh.thmu.edu.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Recruiting
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
-
Contact:
- Jichao Qin, M.D./Ph.D
- Phone Number: +86-27-83665316
- Email: jcqin@tjh.tjmu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Gastric cancer patients undergoing total or proximal gastrectomy in five medical centers (Tongji Hospital, Wuhan No. 1 Hospital, Xianning Central Hospital, Huanggang Central Hospital and Jingzhou Central Hospital) are included in this perspective study.
Description
Inclusion Criteria:
Inclusion Criteria:
- Aged older than 18 years and younger than 85 years.
- Primary gastric adenocarcinoma confirmed by preoperative pathology.
- Expected curative resection via total or proximal gastrectomy.
- American Society of Anesthesiologists (ASA) class I, II, or III.
- Written informed consent.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of anastomotic leakage
Time Frame: Within 30 days after operation
|
Within 30 days after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2022
Primary Completion (Anticipated)
January 6, 2024
Study Completion (Anticipated)
April 6, 2024
Study Registration Dates
First Submitted
December 1, 2022
First Submitted That Met QC Criteria
December 9, 2022
First Posted (Estimate)
December 12, 2022
Study Record Updates
Last Update Posted (Estimate)
December 12, 2022
Last Update Submitted That Met QC Criteria
December 9, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJ-IRB20211255
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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