Phase 4
Completed N=214
CO2 Versus Air Insufflation for Single-balloon Enteroscopy
Intubation Depth
Source: ClinicalTrials.gov NCT01758900 ↗
Enrolled (actual)
214
Serious AEs
0.9%
Results posted
Jul 2016
Primary outcomePrimary: Intubation Depth — 323.8; 238.3 cm
◆ Published Evidence
Established
49citations · ~4 / year
Carbon dioxide insufflation improves the intubation depth and total enteroscopy rate in single-balloon enteroscopy: a randomised, controlled, double-blind trial.
Summary
Small-balloon enteroscopy is a novel endoscopy system for examination of the deep small intestine.Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP(endoscopic retrograde cholangiopancreatography) and DBE(double-balloon enteroscopy) examination, but it is still uncertain to the SBE(single-balloon enteroscopy) procedure.
Linked Publications
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Carbon dioxide insufflation improves the intubation depth and total enteroscopy rate in single-balloon enteroscopy: a randomised, controlled, double-blind trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intubation Depth |
323.8; 238.3 | — |
| SECONDARY Total Enteroscopy Rate |
37; 19 | — |
| SECONDARY Diagnostic Rate |
58.5; 47.2 | — |
| SECONDARY Patient's Acceptability |
105; 107 | — |
| SECONDARY Procedure Time |
77.9; 72.9; 86.4; 75.8; 166.5; 155.1 | — |
| SECONDARY Abdominal Circumference |
73.4; 70.3; 74.1; 73.6 | — |
| SECONDARY Complication Rate |
1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- patients referred for SBE at the trial centre
Exclusion Criteria
- Age under 18 years, over 75 years Refusal of participation GIST(gastrointestinal stromal tumor), apparent tumor, post surgery Crohn's disease, Intestinal obstruction, stenosis, radiation enteritis Severe cardiopulmonary dysfunction
Data sourced from ClinicalTrials.gov (NCT01758900) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.