An interventional study of Predictive model in Double-balloon Enteroscopy, sponsored by Shandong University. Recruiting at 5 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Shandong University · Not applicable, Interventional, and Diagnostic
The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.
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.
Exclusion Criteria:
Endoscopists will obtain the predictive model intervention.
Other: Predictive model
Endoscopists will not obtain the predictive model intervention.
Endoscopists obtain the patient's predictive model scores before double-balloon enteroscopy.
Total enteroscopy rate
Total enteroscopy rate was defined as the number of patients with complete visualization of the small bowel divided by the total number of patients.
Time frame: 8 months
Diagnostic yield
Positive findings included vascular malformation, ulcer, polyp, diverticulum and others.
Time frame: 8 months
Procedural time
The total time of antegrade and retrograde insertions
Time frame: 8 months
Adverse events
Adverse reactions refer to bleeding, perforation, aspiration pneumonia, acute pancreatitis and other conditions related to double-balloon enteroscopy.
Time frame: 8 months
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Shandong University