Phase 4 N=214 Randomized Triple-blind Diagnostic

CO2 Versus Air Insufflation for Single-balloon Enteroscopy

Intubation Depth

Bottom Line

View on ClinicalTrials.gov: NCT01758900 ↗

Enrolled (actual)

214

Serious AEs

0.9%

Results posted

Jul 2016

Primary outcome: Primary: Intubation Depth — 323.8; 238.3 cm

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: CO2 insufflation regulator (Device); Air insufflation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Zhizheng Ge
Primary completion: May 2013

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	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT01758900). 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.