Comparing one-person and two-person techniques in single-balloon enteroscopy
Single-operator Versus Two-operator Technique in Single-balloon Enteroscopy: a Prospective, Multicenter, Non-inferiority Randomized Controlled Trial
This study is testing whether one doctor can do a small bowel procedure more effectively and comfortably for patients than two doctors working together.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Locations | 6 sites (Lanzhou, Gansu and 5 other locations) |
| Trial ID | NCT06280469 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of single-operator versus double-operator techniques in single-balloon enteroscopy for diagnosing and treating small bowel diseases. It aims to evaluate whether a single operator can provide better observation and treatment of lesions, reduce examination time, and minimize postoperative discomfort compared to a two-person approach. The study will involve patients suspected of having small bowel disease and will assess the depth of insertion and overall examination quality. By focusing on a more efficient method, the study seeks to optimize resource use in endoscopy rooms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have suspected small bowel disease and are scheduled for enteroscopy.
Not a fit: Patients with a history of small bowel surgery or those who are not suitable for general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more efficient and comfortable procedures for patients with small bowel diseases.
How similar studies have performed: While there is limited comparative research on single versus double-operator techniques in single-balloon enteroscopy, the approach of optimizing procedural efficiency is gaining interest in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age greater than eighteen years; * suspected small bowel disease with planned enteroscopy Exclusion Criteria: * patients with a history of small bowel surgery; * patients who fail to perform bowel preparation as required; * patients with existing esophageal varices at high risk of bleeding; * patients not requiring a deep small-bowel examination, such as those with lesions clearly localized to the proximal jejunum, or terminal ileum; * patients who are in extremely poor physical condition and are not suitable for general anesthesia, as defined by an ASA score greater than 3; * pregnant or lactating women; * patients unable to provide written informed consent.
Where this trial is running
Lanzhou, Gansu and 5 other locations
- The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Recruiting)
- The Second Hospital & Clinical Medical School, Lanzhou University — Lanzhou, Gansu, China (Recruiting)
- The Fifth Affiliated Hospital of Zunyi Medical University — Zhuhai, Guangdong, China (Recruiting)
- The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shannxi, China (Recruiting)
- Xi'an Honghui Hospital — Xi'an, Shannxi, China (Recruiting)
- Xijing Hospital of Digestive Diseases — Xi'an, Shannxi, China (Recruiting)
Study contacts
- Study coordinator: Shuhui Liang
- Email: liangsh@fmmu.edu.cn
- Phone: 86-20-84771536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.