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Validation of a Model for Predicting Anastomotic Leakage

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ClinicalTrials.gov Identifier: NCT05646290
Recruitment Status : Recruiting
First Posted : December 12, 2022
Last Update Posted : December 12, 2022
Sponsor:
Information provided by (Responsible Party):
Jichao Qin, Tongji Hospital

Tracking Information
First Submitted Date December 1, 2022
First Posted Date December 12, 2022
Last Update Posted Date December 12, 2022
Actual Study Start Date January 6, 2022
Estimated Primary Completion Date January 6, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2022)		 Incidence of anastomotic leakage [ Time Frame: Within 30 days after operation ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of a Model for Predicting Anastomotic Leakage
Official Title Validation of a Machine Learning Model for Predicting Anastomotic Leakage of Esophagogastrostomy and Esophagojejunostomy: A Multicenter Prospective Study
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Gastric Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 9, 2022)		 880
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 6, 2024
Estimated Primary Completion Date January 6, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jichao Qin, M.D./Ph.D +86-27-83665316 jcqin@tjh.thmu.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT05646290
Other Study ID Numbers TJ-IRB20211255
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Jichao Qin, Tongji Hospital
Original Responsible Party Same as current
Current Study Sponsor Jichao Qin
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Tongji Hospital
Verification Date December 2022