Effect of Predictive Model on Double-Balloon Enteroscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Predictive model.
- Who it may be relevant to
- Registry conditions: Double-balloon Enteroscopy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Predictive Model on Total Double-Balloon Enteroscopy Rate: a Randomized Controlled Trial
Overview
The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.
Detailed description
Double-balloon enteroscopy is a new and effective endoscopic technique used for the diagnosis and treatment of small intestinal diseases. Due to its deep intubation ability, it can achieve complete visualization of the small intestinal mucosa, that is, total enteroscopy. Theoretically, a higher total enteroscopy rate could be associated with a greater possibility of detecting positive lesions. However, a total enteroscopy is a challenging procedure for endoscopists. Endoscopists cannot accurately predict the operational difficulty of patients before the operation, which leads to the passivity of preoperative preparation and intraoperative strategy formulation.
Recently, the Department of Gastroenterology of Qilu Hospital of Shandong University has completed the development and external validation of the first double-balloon enteroscopy prediction model. A preoperative individualized assessment of the difficulty of total enteroscopy can be achieved using this model. Therefore, a multicenter randomized controlled study was designed to assess the performance of predictive model in double-balloon enteroscopy, including total enteroscopy rate, positive findings, procedural time, adverse events and other indicators.
Interventions
- Other Predictive model
Endoscopists obtain the patient's predictive model scores before double-balloon enteroscopy.
Primary outcome measures
- Total enteroscopy rate [Time frame: 8 months]
Secondary outcome measures (3)
- Diagnostic yield [Time frame: 8 months]
- Procedural time [Time frame: 8 months]
- Adverse events [Time frame: 8 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
China · 5 centers
- Dezhou People's Hospital — Dezhou
- Qilu Hospital of Shandong University (Qingdao) — Qingdao
- Yantai Affiliated Hospital of Binzhou Medical University — Yantai
- Zaozhuang Municipal Hospital — Zaozhuang
- Qilu Hospital of Shandong University — Jinan
Identifiers
NCT: NCT07288346 · QLCR20250630