Gastric CancersNCT06807372
Validation of a Model for Predicting Duodenal Stump Leakage After Gastrectomy
An observational study of Gastric Cancers, run by Jichao Qin at 1 site in China.
Trial summary
This study aims to validate a machine learning model for predicting duodenal stump leakage after laparoscopic radical gastrectomy for gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Cancers
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged older than 18 years and younger than 85 years
- Primary gastric carcinoma confirmed by preoperative pathology result
- Expected curative resection via laparoscopic distal or total gastrectomy and reconstruction via Billroth-II or Roux-en-Y anastomosis
- American Society of Anesthesiologists (ASA) class I, II, or III
- With full documents of preoperative examinations such as blood test and abdominal CT scanning
- Written informed consent
Who cannot join
- 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
- Performed gastrectomy in the past
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: A Multicenter Prospective Study of Artificial Intelligence Predicting Duodenal Stump Leakage After Laparoscopic Radical Gastrectomy for Gastric Cancer
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.
- Conditions
- Gastric Cancers
- Keywords
- artificial intelligence, gastric cancer, duodenal stump leakage, radical gastrectomy
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of duodenal stump leakage
Measured: Within 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start11 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jichao Qin
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Jinhua Central Hospital, Second Affiliated Hospital of Nanchang University
- Responsible party
- Sponsor-investigator, Jichao Qin, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807372
- Sponsor's protocol ID
- 2024-0856
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study of Artificial Intelligence Predicting Duodenal Stump Leakage After Laparoscopic Radical Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT06807372
- Acronym / sponsor ID
- 2024-0856
- Conditions
- Gastric Cancers
- Keywords
- artificial intelligence, gastric cancer, duodenal stump leakage, radical gastrectomy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Jichao QinUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Jinhua Central Hospital, Second Affiliated Hospital of Nanchang University
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Aged older than 18 years and younger than 85 years
- Primary gastric carcinoma confirmed by preoperative pathology result
- Expected curative resection via laparoscopic distal or total gastrectomy and reconstruction via Billroth-II or Roux-en-Y anastomosis
- American Society of Anesthesiologists (ASA) class I, II, or III
- With full documents of preoperative examinations such as blood test and abdominal CT scanning
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of duodenal stump leakage
Time frame: Within 30 days after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancers, run by Jichao Qin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of duodenal stump leakage (time frame: Within 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.