CO2 Versus Air Insufflation for Single-balloon Enteroscopy

October 13, 2016 updated by: Zhizheng Ge

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Air insufflation regulator
Room air will be used for insufflation as the Active Comparator arm
Device: Air insufflation
The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.
EXPERIMENTAL: CO2 insufflation regulator
Device: CO2 insufflation regulator
Device: CO2 insufflation regulator
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intubation Depth
Time Frame: Within 5 minutes after the examination
Within 5 minutes after the examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Enteroscopy Rate
Time Frame: Within 1 week after all the examinations are finished
Within 1 week after all the examinations are finished
Diagnostic Rate
Time Frame: Within 1 week after all the examinations are finished
Within 1 week after all the examinations are finished
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.
6 hours after the examination
Procedure Time
Time Frame: Within 5 minutes after the examination
Within 5 minutes after the examination
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.
10 minutes before/after the examination
Complication Rate
Time Frame: Within 1 week after all the examinations are finished
Within 1 week after all the examinations are finished

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhizheng Ge

Investigators

  • Principal Investigator: Zhizheng Ge, Ph.D. MD., Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine Shanghai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 27, 2012

First Posted (ESTIMATE)

January 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • rjer2011-70k

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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