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

ConditionsSingle-balloon EnteroscopyOperation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShuhui Liang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age greater than eighteen years;

suspected small bowel disease with planned enteroscopy

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Single-Balloon Enteroscopy

    Procedure/Surgery

    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.

Treatment groups

228 Participants
are divided into 2 treatment groups
Group A: Single operator groupExperimental treatment 1 intervention
Group B: Two operator groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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)
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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Shuhui Liang

Lead sponsor

Xijing Hospital of Digestive Diseases

Sponsor institution

Source ClinicalTrials.gov
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