CO2 Versus Air Insufflation for Single-balloon Enteroscopy

Study Overview
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Brief Summary
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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
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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

Official Title
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CO2 Versus Air Insufflation for Single-balloon Enteroscopy: a Randomized, Controlled Trial

Conditions
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Intubation Depth

Intervention / Treatment
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* Device: CO2 insufflation regulator
* Device: Air insufflation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Air insufflation regulator<br>Room air will be used for insufflation as the Active Comparator arm | Device: Air insufflation<br>* The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.<br>|
| Experimental: CO2 insufflation regulator<br>Device: CO2 insufflation regulator | Device: CO2 insufflation regulator<br>* The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Depth |  | Within 5 minutes after the examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Acceptability | 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. | 6 hours after the examination | 
| Procedure Time |  | Within 5 minutes after the examination | 
| Abdominal Circumference | 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. | 10 minutes before/after the examination | 
| Complication Rate |  | Within 1 week after all the examinations are finished | 
| Total Enteroscopy Rate |  | Within 1 week after all the examinations are finished | 
| Diagnostic Rate |  | Within 1 week after all the examinations are finished | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single-Balloon Enteroscopy