Single-operator Versus Two-operator Technique in Single-balloon Enteroscopy
SBE
1 other identifier
interventional
206
1 country
6
Brief Summary
Compared to two-operator single-balloon enteroscopy, single-operator procedure not only offer better maneuverability but may also prevent prolonged examination times and potential complications caused by poor coordination between operators. Additionally, it can optimize staffing in the endoscopy suite. However, there are no studies comparing the effects of single-operator and two-operator techniques on single-balloon enteroscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
March 31, 2026
July 1, 2025
2.1 years
February 19, 2024
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum insertion depth
The maximum insertion position was recognized as reached when the scope could not be advanced further after 30 minutes of attempts
From enrollment to the completion of enteroscopy
Secondary Outcomes (4)
Total enteroscopy
From enrollment to the completion of enteroscopy (oral, anal, or combined dual-route examination)
Positive finding
From enrollment to the completion of enteroscopy
Advent events
From enrollment to the completion of enteroscopy within 30 days
Procedural time
From enrollment to the completion of enteroscopy
Study Arms (2)
Single operator group
EXPERIMENTALEnteroscope and splinting tube are operated by one endoscopist.
Two operator group
EXPERIMENTALEnteroscope is operated by one endoscopist and splinting tube is operated by one assistant
Interventions
Insertion procedure of single-balloon enteroscopy. (1) Insert the scope. (2) Angulate the scope to hold the gut and deflate the balloon. (3) Advance the splinting tube. (4) Inflate the balloon. (5) Withdraw both the scope and splinting tube while releasing the angulation. (6) Withdraw both the scope and splinting tube to shorten the intestine. (7) Repeat these steps until the scope reaches the deep part of the small bowel.
Eligibility Criteria
You may qualify if:
- age greater than eighteen years;
- suspected small bowel disease with planned enteroscopy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shuhui Lianglead
Study Sites (6)
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
The Fifth Affiliated Hospital of Zunyi Medical University
Zhuhai, Guangdong, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, China
Xi'an Honghui Hospital
Xi'an, Shannxi, China
Xijing Hospital of Digestive Diseases
Xi'an, Shannxi, China
Related Publications (2)
Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Okamoto R, Kanai T, Watanabe M. Single-operator method for double-balloon endoscopy: a pilot study. Endoscopy. 2008 Nov;40(11):936-8. doi: 10.1055/s-2008-1077545. Epub 2008 Sep 25.
PMID: 18819060BACKGROUNDYamamoto H, Ogata H, Matsumoto T, Ohmiya N, Ohtsuka K, Watanabe K, Yano T, Matsui T, Higuchi K, Nakamura T, Fujimoto K. Clinical Practice Guideline for Enteroscopy. Dig Endosc. 2017 Jul;29(5):519-546. doi: 10.1111/den.12883. Epub 2017 Jun 9.
PMID: 28370422BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 19, 2024
First Posted
February 28, 2024
Study Start
May 1, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
March 31, 2026
Record last verified: 2025-07