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

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Maximum insertion depth [Time frame: From enrollment to the completion of enteroscopy]

Secondary outcome measures (4)

• Total enteroscopy [Time frame: 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]
• Advent events [Time frame: From enrollment to the completion of enteroscopy within 30 days]
• Procedural time [Time frame: From enrollment to the completion of enteroscopy]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Diagnostic

Study locations

China · 6 centers

• The First Hospital of Lanzhou University — Lanzhou
• The Second Hospital & Clinical Medical School, Lanzhou University — Lanzhou
• The Fifth Affiliated Hospital of Zunyi Medical University — Zhuhai
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an
• Xi'an Honghui Hospital — Xi'an
• Xijing Hospital of Digestive Diseases — Xi'an

Publications

• 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 18819060
• Yamamoto 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 28370422

Identifiers

NCT: NCT06280469 · KY20232298-F-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗