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Active, not recruitingNCT06807372Updated Mar 10, 2026

Validation of a Model for Predicting Duodenal Stump Leakage After Gastrectomy

An observational study in Gastric Cancers, sponsored by Jichao Qin. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Jichao Qin · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,200
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This study aims to validate a machine learning model for predicting duodenal stump leakage after laparoscopic radical gastrectomy for gastric cancer.

Read the detailed description

Gastrectomy is an essential procedure in radical surgery for gastric cancer. Duodenal stump leakage (DSL) is one of the critical short-term complications after distal and total gastrectomy in gastric cancer patients. Identifying patients with high-risk of DSL will assist the surgeons' decision making to give efficient previous intervention, such as a more rigorous operation, placing dual-lumen flushable drainage catheter and decompression tube in afferent loop. Investigators have developed a high-performance machine learning model based on 4070 gastric cancer patients, which showed good discrimination of DSL. Hence, this multi-center prospective study will validate the reliability of this model for predicting DSL in gastric cancer patients who receive laparoscopic distal or total gastrectomy.

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Conditions studied

  • Gastric Cancers

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Keywords

  • artificial intelligence
  • gastric cancer
  • duodenal stump leakage
  • radical gastrectomy
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In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms 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
Probability sample

Study population

This study involves the population of the First Affiliated Hospital of School of Medicine, Zhejiang University, the Second Affiliated Hospital of School of Medicine, Zhejiang University and Jinhua Central Hospital.

Inclusion criteria

  1. Aged older than 18 years and younger than 85 years
  2. Primary gastric carcinoma confirmed by preoperative pathology result
  3. Expected curative resection via laparoscopic distal or total gastrectomy and reconstruction via Billroth-II or Roux-en-Y anastomosis
  4. American Society of Anesthesiologists (ASA) class I, II, or III
  5. With full documents of preoperative examinations such as blood test and abdominal CT scanning
  6. Written informed consent

Exclusion criteria

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
  6. Performed gastrectomy in the past
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,200 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Incidence of duodenal stump leakage

    Time frame: Within 30 days after operation

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Study locations

1 site
  • Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310000, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2026, 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
NCT06807372
Lead sponsor
Jichao Qin
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University, Jinhua Central Hospital, Second Affiliated Hospital of Nanchang University
Responsible party
Jichao Qin (Professor, First Affiliated Hospital of Zhejiang University) — Sponsor-investigator
First posted
Feb 4, 2025
Start date
Sep 11, 2024
Primary completion
Sep 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Mar 10, 2026

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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