NCT06280469

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Shuhui Liang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Single-balloon Enteroscopy
• Operation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-02-28
• Last updated: 2026-03-31

Locations

6 sites across 1 country: China