Effect of Predictive Model on Double-Balloon Enteroscopy

Shandong University

Status: Enrolling

Conditions: Double-balloon Enteroscopy

Treatments: Other: Predictive model

Study type: Interventional

Funder types: Other

Identifiers

NCT07288346

QLCR20250630

Details and patient eligibility

About

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

Full 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.

Enrollment: 338 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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338 participants in 2 patient groups

Predictive model group

Experimental group

Description:

Endoscopists will obtain the predictive model intervention.

Treatment:

Other: Predictive model

Control group

No Intervention group

Description:

Endoscopists will not obtain the predictive model intervention.