Effect of Predictive Model on Double-Balloon Enteroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2027-08-31

Brief Summary

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The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.

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Detailed Description

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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.

Conditions

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Double-balloon Enteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Predictive model group

Endoscopists will obtain the predictive model intervention.

Group Type EXPERIMENTAL

Predictive model

Intervention Type OTHER

Endoscopists obtain the patient's predictive model scores before double-balloon enteroscopy.

Control group

Endoscopists will not obtain the predictive model intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Predictive model

Endoscopists obtain the patient's predictive model scores before double-balloon enteroscopy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. patients aged between 18 and 80 years who were planned to undergo an attempt at total enteroscopy for suspected small-bowel disease
2. CT scan of the abdomen was performed within two weeks before enteroscopy

Exclusion Criteria

1. cases terminated upon the target lesion (strictures, masses, hemorrhagic or other lesions) and not the maximal insertion
2. poor quality of bowel preparation
3. high risk esophageal varices
4. the insertion route is not oral or anal because of changes in anatomical structure
5. unsuitable for general anesthesia
6. pregnant women
7. unable to provide informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No