Clinical trial NCT06807372: Validation of a Model for Predicting Duodenal Stump Leakage After Gastrectomy
Official title: A Multicenter Prospective Study of Artificial Intelligence Predicting Duodenal Stump Leakage After Laparoscopic Radical Gastrectomy for Gastric Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastric Cancers
Keywords: artificial intelligence
gastric cancer
duodenal stump leakage
radical gastrectomy
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jinhua Central Hospital
First posted: 2025-02-04
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Incidence of duodenal stump leakage
timeFrame: Within 30 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: