Operation, Single-balloon Enteroscopy
Conditions
Keywords
single operator, two operator, enteroscopy
Brief 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.
Interventions
PROCEDURESingle-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.
Sponsors
Shuhui Liang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum insertion depth | 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
| Measure | Time frame | Description |
|---|---|---|
| Total enteroscopy | 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. |
| Positive finding | From enrollment to the completion of enteroscopy | A positive finding was made only when the lesions found could clearly explain the clinical manifestations. |
| Advent events | From enrollment to the completion of enteroscopy within 30 days | Adverse event was defined as any event that changed the health status of patient. |
| Procedural time | From enrollment to the completion of enteroscopy | including the full operative time, enteroscope insertion time, enteroscope exit time, and other relevant procedural time segments. |
Countries
China
Contacts
CONTACTShuhui Liang
CONTACTHui Luo
Outcome results
None listed