Using a prediction tool to improve complete small-bowel exams with double-balloon enteroscopy
Official title: Effect of Predictive Model on Total Double-Balloon Enteroscopy Rate: a Randomized Controlled Trial
Run by Shandong University · NCT07288346 · Data updated 2026-11-12
This trial will test whether a preoperative prediction model helps doctors achieve complete small-bowel examination during double-balloon enteroscopy in adults being evaluated for suspected small-bowel disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 338 (estimated) |
| Sponsor | Shandong University Academic / other |
| Locations | 5 sites (Dezhou, Shandong and 4 other locations) |
| Status | Recruiting |
| Started | January 12, 2026 |
| Main results expected | May 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT07288346 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 who are scheduled for an attempt at total enteroscopy for suspected small-bowel disease and who have had an abdominal CT within two weeks are the intended participants.
✕Probably not a fit
Patients with poor bowel preparation, high-risk esophageal varices, non-oral/anal altered anatomy, those unable to undergo general anesthesia, pregnant patients, or cases terminated at a target lesion are unlikely to benefit from the prediction model.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Investigators will run a multicenter randomized trial comparing use of a preoperative predictive model to usual planning for double-balloon enteroscopy across three hospitals in Shandong, China. The model, previously developed and externally validated by the Department of Gastroenterology at Qilu Hospital, provides an individualized estimate of how difficult achieving total enteroscopy may be. Primary and secondary outcomes include total enteroscopy rate, detection of positive findings, procedure time, and adverse events. Eligible adults scheduled for an attempt at total enteroscopy must have a recent abdominal CT and meet standard anesthesia and consent criteria.
Why it matters
Potential benefit: If successful, the model could increase the rate of complete small-bowel exams and improve lesion detection while helping tailor procedure planning to lower procedure time and complications.
How similar studies have gone: This is the first prediction model developed specifically for double-balloon enteroscopy and it has undergone external validation, but randomized multicenter testing of its clinical impact is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Dezhou People's Hospital
Dezhou, Shandong, China Recruiting -
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, China Recruiting -
Yantai Affiliated Hospital of Binzhou Medical University
Yantai, Shandong, China Recruiting -
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China Recruiting -
Qilu Hospital of Shandong University
Jinan, Shangdong, China Recruiting
Study contacts
- Study coordinator: Xiuli Zuo
- Email: xiulizuo@sdu.edu.cn
- Phone: 86-0531-82165292
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.