Single-operator Versus Two-operator Technique in Single-balloon Enteroscopy (SBE)

March 25, 2026 updated by: Shuhui Liang

Single-operator Versus Two-operator Technique in Single-balloon Enteroscopy: a Prospective, Multicenter, Non-inferiority Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Balloon-assisted enteroscopy (BAE) has been used for diagnosing and treating small bowel diseases for over two decades. Insertion depth is a key quality indicator for enteroscopy performance. Although several adjunctive techniques have been introduced to enhance insertion depth, including carbon dioxide insufflation, transparent cap attachment, and water exchange method, operator proficiency consistently remains the most critical determinant of procedural success.

Single-balloon enteroscopy (SBE), through design optimization, offers simplified operation and a shorter learning curve compared with the double-balloon enteroscopy (DBE). Nevertheless, its procedural approach has not been revised. Clinical practice guidelines recommend the conventional two-operator technique originally established for DBE. In this setting, suboptimal coordination between the endoscopist and assistant, particularly with respect to timing and force modulation during overtube advancement and withdrawal, may not only substantially compromise insertion depth but also increases the risk of procedural complications.

Single-operator enteroscopy technique has been previously described reported. Independent control of both the enteroscope and overtube by a single operator theoretically maximizes instrumental flexibility, potentially conferring significant advantages in technical maneuvers and loop reduction. Furthermore, this approach may reduce procedure duration and optimize endoscopy unit staffing efficiency. Nevertheless, whether the single-operator technique compromises enteroscopy performance-particularly insertion depth, a primary determinant of diagnostic yield-has not been rigorously evaluated.

We therefore designed a multicenter, randomized controlled non-inferiority trial to compare single-operator versus two-operator technique with respect to insertion depth and lesion detection rate during single-balloon enteroscopy.

Study Type

Interventional

Enrollment (Estimated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
      • Lanzhou, Gansu, China
        • Recruiting
        • The Second Hospital & Clinical Medical School, Lanzhou University
        • Contact:
    • Guangdong
      • Zhuhai, Guangdong, China
        • Recruiting
        • The Fifth Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Shannxi
      • Xi'an, Shannxi, China
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shannxi, China
        • Recruiting
        • Xi'an Honghui Hospital
        • Contact:
      • Xi'an, Shannxi, China
        • Recruiting
        • Xijing Hospital of Digestive Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single operator group
Enteroscope and splinting tube are operated by one endoscopist.
Procedure: Single-Balloon Enteroscopy
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.
Other Names:
  • SBE
Experimental: Two operator group
Enteroscope is operated by one endoscopist and splinting tube is operated by one assistant
Procedure: Single-Balloon Enteroscopy
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.
Other Names:
  • SBE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum insertion depth
Time Frame: From enrollment to the completion of enteroscopy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total enteroscopy
Time Frame: From enrollment to the completion of enteroscopy (oral, anal, or combined dual-route examination)
In patients with clinical indications for total enteroscopy, the procedure was defined as: (1) intubation to the ileocecal valve for oral single-balloon enteroscopy (SBE); (2) intubation to the pylorus for anal SBE; or (3) entire small-bowel visualization upon identification of the marker during the initial route via the second route.
From enrollment to the completion of enteroscopy (oral, anal, or combined dual-route examination)
Positive finding
Time Frame: From enrollment to the completion of enteroscopy
A positive finding was made only when the lesions found could clearly explain the clinical manifestations.
From enrollment to the completion of enteroscopy
Advent events
Time Frame: From enrollment to the completion of enteroscopy within 30 days
Adverse event was defined as any event that changed the health status of patient.
From enrollment to the completion of enteroscopy within 30 days
Procedural time
Time Frame: From enrollment to the completion of enteroscopy
including the full operative time, enteroscope insertion time, enteroscope exit time, and other relevant procedural time segments.
From enrollment to the completion of enteroscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shuhui Liang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232298-F-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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