NCT07288346

Effect of Predictive Model on Double-Balloon Enteroscopy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 338 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Double-balloon Enteroscopy

Interventions

Type	Name	Description
OTHER	Predictive model	Endoscopists obtain the patient's predictive model scores before double-balloon enteroscopy.

Timeline

• Start date: 2026-01-12
• Primary completion: 2027-05-31
• Completion: 2027-08-31
• First posted: 2025-12-17
• Last updated: 2026-01-13

Locations

5 sites across 1 country: China