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NCT Number: NCT07288346

Effect of Predictive Model on Double-Balloon Enteroscopy

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dezhou People's Hospital, Dezhou, Shandong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Predictive model

Other

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

Primary outcomes

  1. Total enteroscopy rate

    Time frame: 8 months

    Total enteroscopy rate was defined as the number of patients with complete visualization of the small bowel divided by the total number of patients.

Secondary outcomes

  1. Diagnostic yield

    Time frame: 8 months

    Positive findings included vascular malformation, ulcer, polyp, diverticulum and others.

  2. Procedural time

    Time frame: 8 months

    The total time of antegrade and retrograde insertions

  3. Adverse events

    Time frame: 8 months

    Adverse reactions refer to bleeding, perforation, aspiration pneumonia, acute pancreatitis and other conditions related to double-balloon enteroscopy.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Dezhou People's Hospital
  • Qilu Hospital of Shandong University (Qingdao)
  • Yantai Affiliated Hospital of Binzhou Medical University
  • Zaozhuang Municipal Hospital

Registry information

Official study title

Effect of Predictive Model on Total Double-Balloon Enteroscopy Rate: a Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.