CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 107 enrolled
Drug / intervention
Single-Balloon-Enteroscopy with Air as insufflation gas. +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01524055
NCT01524055Phase 3Completed

CO2 Insufflation During Single-Balloon-Enteroscopy

University Hospital Muenster·interventional·Posted Feb 1, 2012·Updated Nov 26, 2013

In Brief

A Phase 3 clinical trial evaluating Single-Balloon-Enteroscopy with Air as insufflation gas. and Single-Balloon-Enteroscopy with CO2 as insufflation gas. for Pain. Completed, enrolled 107 participants across 4 sites in 2 countries.

Detailed Summary

Double-balloon enteroscopy (DBE) was introduced 2001 for visualizing the entire small bowel. In 2008, a novel balloon-assisted enteroscope system has been developed using only a single balloon (single-balloon enteroscope, SBE). SBE was designed to facilitate diagnosis and treatment of the small bowel. The investigators could demonstrate the both endoscopic procedures are equally suitable in the clinical routine. In both balloon-assisted endoscopic procedures (balloon-assisted enteroscopy (BAE)) it is mandatory to insufflate gas into the bowel to secure good visualization. All endoscopes used for GI endoscopy provide a gas insufflation unit. Currently, many endoscopy units use air for this purpose. The use of air, however, is far from ideal for insufflation in GI endoscopy. During and after GI endoscopy, significant amounts of air are usually retained in the bowel segment inspected. This air has to pass the GI tract and exit physiologically through the rectum. Thus, abdominal pain and discomfort during and after the examination due to the retention of air have been shown to be very common during and after endoscopic procedures. Carbon dioxide gas (CO2), unlike air, is rapidly absorbed from the bowel. Within minutes, several liters of CO2 can be absorbed from the GI tract. The use of CO2 has been shown to result in more comfortable examinations in both colonoscopy and flexible sigmoidoscopy in several randomized trials. In these studies, CO2 insufflation had almost completely reduced procedure-related pain and discomfort. In 2007, the investigators could demonstrate the advantages of CO2-Insufflation in DBE. Another group confirmed our findings. To our knowledge, no study has been performed investigating the use of CO2 in SBE. The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in SBE patients. Furthermore, the investigators want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope, as shown for the DBE technique.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesGermany, Italy

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2012
Enrollment StartDec 1, 2011
Primary CompletionFeb 1, 2013
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.4 years ago

Interventions

Single-Balloon-Enteroscopy with Air as insufflation gas.device

Single-Balloon-Enteroscopy will be performed using Air as insufflation gas to inflate the intestine for complete examination.

Single-Balloon-Enteroscopy with CO2 as insufflation gas.device

Single-Balloon-Enteroscopy will be performed using CO2 as insufflation gas to inflate the intestine for complete examination.