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.
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
Allocation
RANDOMIZED
Purpose
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.
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGThe Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
RECRUITINGThe Fifth Affiliated Hospital of Zunyi Medical University
Zhuhai, Guangdong, China
Maximum insertion depth
The maximum insertion position was recognized as reached when the scope could not be advanced further after 30 minutes of attempts
Time frame: From enrollment to the completion of enteroscopy
Total enteroscopy
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.
Time frame: From enrollment to the completion of enteroscopy (oral, anal, or combined dual-route examination)
Positive finding
A positive finding was made only when the lesions found could clearly explain the clinical manifestations.
Time frame: From enrollment to the completion of enteroscopy
Advent events
Adverse event was defined as any event that changed the health status of patient.
Time frame: From enrollment to the completion of enteroscopy within 30 days
Procedural time
including the full operative time, enteroscope insertion time, enteroscope exit time, and other relevant procedural time segments.
Time frame: From enrollment to the completion of enteroscopy
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DIAGNOSTIC
Masking
TRIPLE
Enrollment
228
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, China
RECRUITINGXi'an Honghui Hospital
Xi'an, Shannxi, China
RECRUITINGXijing Hospital of Digestive Diseases
Xi'an, Shannxi, China
RECRUITING