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CompletedNCT05646290Updated Nov 21, 2024

Validation of a Model for Predicting Anastomotic Leakage

An observational study in Gastric Cancer, sponsored by Jichao Qin. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Jichao Qin · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
512
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Gastric Cancer

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Keywords

  • machine learning
  • anastomotic leakage
  • total and proximal gastrectomy
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In context

Anastomotic Leak

209 studies on the registry are indexed under Anastomotic Leak; 60 are open to participants now.

This study's enrollment of 512 is above the median of 200 across 108 observational studies indexed under Anastomotic Leak.

Browse Anastomotic Leak studies →

Lead sponsor

Jichao Qin is the lead sponsor of 9 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
512 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Incidence of anastomotic leakage

    Time frame: Within 30 days after operation

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Study locations

1 site
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
    Wuhan, Hubei 430030, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05646290
Lead sponsor
Jichao Qin
Responsible party
Jichao Qin (Professor, Tongji Hospital) — Sponsor-investigator
First posted
Dec 12, 2022
Start date
Jan 6, 2022
Primary completion
Mar 15, 2024
Completion
May 6, 2024
Last update
Nov 21, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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