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Effect of Predictive Model on Double-Balloon Enteroscopy

Effect of Predictive Model on Double-Balloon Enteroscopy

Recruiting
18-80 years
All
Phase N/A

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Overview

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

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.

Eligibility

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

Study details
    Double-balloon Enteroscopy

NCT07288346

Shandong University

31 January 2026

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