CO2 Insufflation During Single-Balloon-Enteroscopy

November 25, 2013 updated by: University Hospital Muenster

Double-balloon enteroscopy (DBE) was introduced 2001 for visualizing the entire small bowel. In 2008, a novel balloon-assisted enteroscope system has been developed using only a single balloon (single-balloon enteroscope, SBE). SBE was designed to facilitate diagnosis and treatment of the small bowel. The investigators could demonstrate the both endoscopic procedures are equally suitable in the clinical routine. In both balloon-assisted endoscopic procedures (balloon-assisted enteroscopy (BAE)) it is mandatory to insufflate gas into the bowel to secure good visualization. All endoscopes used for GI endoscopy provide a gas insufflation unit. Currently, many endoscopy units use air for this purpose. The use of air, however, is far from ideal for insufflation in GI endoscopy. During and after GI endoscopy, significant amounts of air are usually retained in the bowel segment inspected. This air has to pass the GI tract and exit physiologically through the rectum. Thus, abdominal pain and discomfort during and after the examination due to the retention of air have been shown to be very common during and after endoscopic procedures. Carbon dioxide gas (CO2), unlike air, is rapidly absorbed from the bowel. Within minutes, several liters of CO2 can be absorbed from the GI tract. The use of CO2 has been shown to result in more comfortable examinations in both colonoscopy and flexible sigmoidoscopy in several randomized trials. In these studies, CO2 insufflation had almost completely reduced procedure-related pain and discomfort.

In 2007, the investigators could demonstrate the advantages of CO2-Insufflation in DBE. Another group confirmed our findings. To our knowledge, no study has been performed investigating the use of CO2 in SBE.

The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in SBE patients. Furthermore, the investigators want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope, as shown for the DBE technique.

Study Overview

Detailed Description

Double-balloon enteroscopy (DBE) was introduced 2001 for visualizing the entire small bowel. 2008, a novel balloon enteroscope system has been developed using only a single balloon (single-balloon enteroscope, SBE). SBE was designed to facilitate diagnosis and treatment of the small bowel. We could demonstrate the both endoscopic procedures are equally suitable in the clinical routine. In both balloon-assisted endoscopic procedures (balloon-assisted enteroscopy (BAE)) it is mandatory to insufflate gas into the bowel to secure good visualization. All endoscopes used for GI endoscopy provide a gas insufflation unit. Currently, many endoscopy units use air for this purpose. The use of air, however, is far from ideal for insufflation in GI endoscopy. During and after GI endoscopy, significant amounts of air are usually retained in the bowel segment inspected. This air has to pass the GI tract and exit physiologically through the rectum. Thus, abdominal pain and discomfort during and after the examination due to the retention of air has been shown to be very common during and after endoscopic procedures. Carbon dioxide gas (CO2), unlike air, is rapidly absorbed from the bowel. Within minutes, several liters of CO2 can be absorbed from the GI tract. The use of CO2 has been shown to result in more comfortable examinations in both colonoscopy and flexible sigmoidoscopy in several randomized trials. In these studies, CO2 insufflation almost completely reduced procedure-related pain and discomfort.

In 2007, we could demonstrate the advantages of CO2-Insufflation in DBE. Another group confirmed our findings. To our knowledge, no research has been performed investigating the use of CO2 in SBE.

BAE is a long-lasting procedure. Large volumes of air are insufflated during the procedure, leading to significant distension of the small bowel during and after the examination.

One of the main technical difficulties in BAE is the formation of small bowel loops and sharp angels during deep intubation of the endoscope. These loops and angels are the major restriction to deep intubation of the endoscope. Loops and sharp angels are more pronounced in air-distended bowel segments.

The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in SBE patients. Furthermore, we want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope, as shown for the DBE technique.

Hypothesis

  1. The use of CO2 in SBE leads to a reduction in abdominal pain for the patient when compared with the use of air.
  2. The use of CO2 in SBE leads to deeper intubation when compared to air insufflation.

The study is designed as a two-center randomized controlled trial. Randomization to the two groups (CO2 vs. air insufflation) is performed of individual participant basis.

Randomization to the two groups (CO2 vs air insufflation) is performed on basis of the individual participant. Equally large groups are randomized, using block randomization (blocks of six patients) for each of the participating centers. Randomization (using SPSS statistical software package) is performed by an independent researcher, who is not part of the SBE team.

Individuals eligible for inclusion are patients referred for SBE at the trial centers who do not fulfill one of the following exclusion criteria:

  • Age under 16 years
  • Inability to understand information for participation
  • Refusal of participation

All eligible individuals are informed about the nature of the study. All individuals provide written informed consent before entering the trial. Patients who do not wish to participate in the present trial are treated according to standard procedures (using air insufflation).

All procedures are performed by experienced endoscopists. Both patients and endoscopists are blinded with regard to type of gas used for any particular patient.

Sedation is performed according to current standards at the centers. Single-balloon procedure SBE is performed using the SBE endoscope system (SIF-Q180, Olympus Optical, Tokyo, Japan), as described in the literature 2-4.

Gas insufflation CO2 is insufflated using EZEM equipment (or other, to be specified). Air is insufflated using the ordinary air inlet system of the endoscope rack. The air inlet button is hidden from the view of the endoscopist to prevent unblinding (technical details to be specified in cooperation with company).

For evaluation of pain and discomfort, a questionnaire is used to classify patient pain during and after the procedure. Visual analogue scales (100-mm) are used to quantify abdominal pain during the examination and at 1, 3, 6, and 24 hours after the procedure, as validated in recent studies7,8. The questionnaire is given to every participant after the procedure, to be filled in the next day.

All procedure parameters of interest (e.g. duration, depth of insertion, use of sedatives) are registered by the endoscopist immediately after the examination using the existing GI lab databases.

Ethics The regional ethics committees of the participating centers will be asked for approval of the study protocol.

Power analysis: a 25% improvement of intubation depth is considered to be clinically important to detect. On the basis of our DBE-CO2-study9, power calculation was conducted determining the size of the study (n=66).

Ownership data are owned by the respective centers. Publication of the study results is planned in a peer-reviewed journal. Philipp Lenz and Dirk Domagk will co-ordinate study design, data generation and analysis and a first manuscript draft.

Budget: All procedures in the present study are performed in ordinary patients, with ordinary staff and endoscopists. Therefore, no extra costs occur for personal.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 3

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

      • Muenster, Germany, 48149
        • University Hopstial of Muenster, Department of Medicine B
      • Northeim, Germany, 37154
        • Helios Albert-Schweitzer-Hospital
      • Baggiovara di Modena, Italy, 41126
        • Gastroenterology and Digestive Endoscopy Unit, Nuovo Ospedale Civile S.Agostino-Estense
      • Torino, Italy, 10123
        • San Giovanni Battista University Teaching Hospital, Department of Medicine, Division of Gastroenterology 2

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

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Indication for Single-Balloon-Enteroscopy

Exclusion Criteria:

  • Age under 16 years
  • Inability to understand information for participation
  • Refusal of participation

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Air
Air as insufflation gas during single-balloon enteroscopy.
Single-Balloon-Enteroscopy will be performed using Air as insufflation gas to inflate the intestine for complete examination.
Other Names:
  • SIF-Q180, Olympus Optical, Tokyo, Japan
OTHER: CO2
CO2 as insufflation gas during single-balloon enteroscopy.
Single-Balloon-Enteroscopy will be performed using CO2 as insufflation gas to inflate the intestine for complete examination.
Other Names:
  • SIF-Q180, Olympus Optical, Tokyo, Japan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation depth
Time Frame: 2h
The endoscopists estimate the depth of intubation during each examination using a recently described and validated technique.
2h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with severe adverse events related to the endoscopic procedure
Time Frame: 48h
SAE related to the endoscopic procedure: number of participants with severe adverse events as a measure of safety and tolerability.
48h
Abdominal pain on on the visual analog scale
Time Frame: 24h
For evaluation of pain and discomfort, a questionnaire (Pain scores on the visual analog scale) is used to classify patient pain during and after the procedure.
24h

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Dirk Domagk, M.D., PhD, Department of Medicine B

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

December 1, 2011

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

December 14, 2011

First Submitted That Met QC Criteria

January 27, 2012

First Posted (ESTIMATE)

February 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 18052011
  • CO2 Insufflation During SBE (OTHER: University Hospital of Muenster)

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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