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NCT Number: NCT06280469

Single-operator Versus Two-operator Technique in Single-balloon Enteroscopy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Lanzhou University, Lanzhou, Gansu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single-Balloon Enteroscopy

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shuhui Liang

Other

Registry information

Official study title

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

Acronym: SBE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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