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Completed

NCT Number: NCT01758900

CO2 Versus Air Insufflation for Single-balloon Enteroscopy

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.

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Key information

Conditions

Intubation Depth

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO2 insufflation regulator

Device

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.

Air insufflation

Device

The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.

Primary outcomes

  1. Intubation Depth

    Time frame: Within 5 minutes after the examination

Secondary outcomes

  1. Total Enteroscopy Rate

    Time frame: Within 1 week after all the examinations are finished

  2. Diagnostic Rate

    Time frame: Within 1 week after all the examinations are finished

  3. Patient's Acceptability

    Time frame: 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.

  4. Procedure Time

    Time frame: Within 5 minutes after the examination

  5. Abdominal Circumference

    Time frame: 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.

  6. Complication Rate

    Time frame: Within 1 week after all the examinations are finished

Sponsors and collaborators

Lead sponsor

Zhizheng Ge

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 1, 2013
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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