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CO2 Versus Air Insufflation for Single-balloon Enteroscopy

Z

Zhizheng Ge

Status and phase

Completed
Phase 4

Conditions

Intubation Depth

Treatments

Device: CO2 insufflation regulator
Device: Air insufflation

Study type

Interventional

Funder types

Other

Identifiers

NCT01758900
rjer2011-70k

Details and patient eligibility

About

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.

Full description

Currently, air is more frequently used to insufflate gas into the lumen to ensure the visualization of the mucosa. However, there're some limitations, for instance, significant amounts of air are usually retained in the small bowel, which will lead to the distention and the pain of the gastrointestinal tract during and after the procedure.

Carbon dioxide(CO2), comparing to the air, is rapidly absorbed from the intestine, which allows the bowel to decompress more quickly and potentially decreases intraprocedural and postprocedural pain, sedation medication requirements, procedure time, and recovery time. It is also to the benefit of deeper intubation depth so that higher total enteroscopy rate and diagnostic rate will be achieved.

Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP and DBE examination, but it is still uncertain to the SBE procedure

Enrollment

214 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

214 participants in 2 patient groups

Air insufflation regulator
Active Comparator group
Description:
Room air will be used for insufflation as the Active Comparator arm
Treatment:
Device: Air insufflation
CO2 insufflation regulator
Experimental group
Description:
Device: CO2 insufflation regulator
Treatment:
Device: CO2 insufflation regulator

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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