Effect of Predictive Model on Double-Balloon Enteroscopy
1 other identifier
interventional
338
1 country
5
Brief Summary
The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2025
CompletedFirst Posted
Study publicly available on registry
December 17, 2025
CompletedStudy Start
First participant enrolled
January 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
January 13, 2026
December 1, 2025
1.4 years
December 4, 2025
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Total enteroscopy rate
Total enteroscopy rate was defined as the number of patients with complete visualization of the small bowel divided by the total number of patients.
8 months
Secondary Outcomes (3)
Diagnostic yield
8 months
Procedural time
8 months
Adverse events
8 months
Study Arms (2)
Predictive model group
EXPERIMENTALEndoscopists will obtain the predictive model intervention.
Control group
NO INTERVENTIONEndoscopists will not obtain the predictive model intervention.
Interventions
Endoscopists obtain the patient's predictive model scores before double-balloon enteroscopy.
Eligibility Criteria
You may qualify if:
- patients aged between 18 and 80 years who were planned to undergo an attempt at total enteroscopy for suspected small-bowel disease
- CT scan of the abdomen was performed within two weeks before enteroscopy
You may not qualify if:
- cases terminated upon the target lesion (strictures, masses, hemorrhagic or other lesions) and not the maximal insertion
- poor quality of bowel preparation
- high risk esophageal varices
- the insertion route is not oral or anal because of changes in anatomical structure
- unsuitable for general anesthesia
- pregnant women
- unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dezhou People's Hospitalcollaborator
- Shandong Universitylead
- Qilu Hospital of Shandong University (Qingdao)collaborator
- Yantai Affiliated Hospital of Binzhou Medical Universitycollaborator
- Zaozhuang Municipal Hospitalcollaborator
Study Sites (5)
Dezhou People's Hospital
Dezhou, Shandong, China
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, China
Yantai Affiliated Hospital of Binzhou Medical University
Yantai, Shandong, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shangdong, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Qilu Hospital Gastroenterology Department
Study Record Dates
First Submitted
December 4, 2025
First Posted
December 17, 2025
Study Start
January 12, 2026
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
January 13, 2026
Record last verified: 2025-12