CO2 Insufflation During Single-Balloon-Enteroscopy

This study has been completed.
Sponsor:
Collaborators:
Albert Schweitzer Hospital
Nuovo Ospedale Civile S.Agostino Estense
Azienda Ospedaliera San Giovanni Battista
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01524055
First received: December 14, 2011
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Pain
Device: Single-Balloon-Enteroscopy with Air as insufflation gas.
Device: Single-Balloon-Enteroscopy with CO2 as insufflation gas.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: CO2 Insufflation During Single-Balloon-Enteroscopy

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Intubation depth [ Time Frame: 2h ] [ Designated as safety issue: No ]
    The endoscopists estimate the depth of intubation during each examination using a recently described and validated technique.


Secondary Outcome Measures:
  • Number of participants with severe adverse events related to the endoscopic procedure [ Time Frame: 48h ] [ Designated as safety issue: Yes ]
    SAE related to the endoscopic procedure: number of participants with severe adverse events as a measure of safety and tolerability.

  • Abdominal pain on on the visual analog scale [ Time Frame: 24h ] [ Designated as safety issue: No ]
    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.


Enrollment: 107
Study Start Date: December 2011
Study Completion Date: April 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Air
Air as insufflation gas during single-balloon enteroscopy.
Device: Single-Balloon-Enteroscopy with Air as insufflation gas.
Single-Balloon-Enteroscopy will be performed using Air as insufflation gas to inflate the intestine for complete examination.
Other Name: SIF-Q180, Olympus Optical, Tokyo, Japan
CO2
CO2 as insufflation gas during single-balloon enteroscopy.
Device: Single-Balloon-Enteroscopy with CO2 as insufflation gas.
Single-Balloon-Enteroscopy will be performed using CO2 as insufflation gas to inflate the intestine for complete examination.
Other Name: SIF-Q180, Olympus Optical, Tokyo, Japan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Indication for Single-Balloon-Enteroscopy

Exclusion Criteria:

  • Age under 16 years
  • Inability to understand information for participation
  • Refusal of participation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01524055

Locations
Germany
University Hopstial of Muenster, Department of Medicine B
Muenster, Germany, 48149
HELIOS Albert-Schweitzer-Hospital
Northeim, Germany, 37154
Italy
Gastroenterology and Digestive Endoscopy Unit, Nuovo Ospedale Civile S.Agostino-Estense
Baggiovara di Modena, Italy, 41126
San Giovanni Battista University Teaching Hospital, Department of Medicine, Division of Gastroenterology 2
Torino, Italy, 10123
Sponsors and Collaborators
University Hospital Muenster
Albert Schweitzer Hospital
Nuovo Ospedale Civile S.Agostino Estense
Azienda Ospedaliera San Giovanni Battista
Investigators
Principal Investigator: Dirk Domagk, M.D., PhD Department of Medicine B
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01524055     History of Changes
Other Study ID Numbers: 18052011, CO2 Insufflation During SBE
Study First Received: December 14, 2011
Last Updated: November 25, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on October 01, 2014