Clinical trial NCT01758900: CO2 Versus Air Insufflation for Single-balloon Enteroscopy
Official title: CO2 Versus Air Insufflation for Single-balloon Enteroscopy: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation Depth
Keywords: Single-Balloon Enteroscopy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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

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

Primary outcomes:
measure: Intubation Depth
timeFrame: Within 5 minutes after the examination
Secondary outcomes:
measure: Total Enteroscopy Rate
timeFrame: Within 1 week after all the examinations are finished
measure: Diagnostic Rate
timeFrame: Within 1 week after all the examinations are finished
measure: Patient's Acceptability
timeFrame: 6 hours after the examination
measure: Procedure Time
timeFrame: Within 5 minutes after the examination
measure: Abdominal Circumference
timeFrame: 10 minutes before/after the examination
measure: Complication Rate
timeFrame: Within 1 week after all the examinations are finished
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine Shanghai
name: Zhizheng Ge, Ph.D. MD.
role: PRINCIPAL_INVESTIGATOR
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