CO2 Versus Air Insufflation for Single-balloon Enteroscopy

Phase 4

Completed

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

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
CO2 insufflation regulator	CO2 insufflation regulator	Device: CO2 insufflation regulator
Air insufflation regulator	Air insufflation	Room air will be used for insufflation as the Active Comparator arm

Primary Outcome Measures

Name	Time	Method
Intubation Depth	Within 5 minutes after the examination

Secondary Outcome Measures

Name	Time	Method
Diagnostic Rate	Within 1 week after all the examinations are finished
Total Enteroscopy Rate	Within 1 week after all the examinations are finished
Abdominal Circumference	10 minutes before/after the examination	To measure abdominal circumference, a tape was placed horizontally around the abdomen at the level of the middle location between the level of anterior superior iliac spine and the lower edge of costal arch, and the measurement was made at the end of a normal expiration before and after the procedure.
Procedure Time	Within 5 minutes after the examination
Complication Rate	Within 1 week after all the examinations are finished
Patient's Acceptability	6 hours after the examination	Acceptability was recorded on a questionnaire given to patients after the examination. Patients assessed the degree of abdominal pain/distention along a 10-cm line of the VAS(visual analogue scale), with the 0-cm point labeled "no pain/distention" on left end and the 10-cm point labeled "very severe pain/distention that cannot be tolerated" on the right end. Patients were asked to score the severity of pain/distention experienced at 1, 2, 3 and 6 hours after the completion of the entire examination.

Locations (1): Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
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Shanghai, Shanghai, China