CO2 Insufflation During Single-Balloon-Enteroscopy - Full Text View

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:

MedlinePlus related topics: Abdominal Pain Endoscopy Gas

Drug Information available for: Carbon dioxide

U.S. FDA Resources

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.

Estimated Enrollment:	66
Study Start Date:	December 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (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

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524055

Contacts

Contact: Dirk Domagk, M.D., PhD	+492518347559	domagkd@uni-muenster.de
Contact: Philipp Lenz, M.D.	+492518345089	Lenz.Philipp@ukmuenster.de

Locations

Germany
University Hopstial of Muenster, Department of Medicine B	Recruiting
Muenster, Germany, 48149
Contact: Dirk Domagk, M.D., PhD +492518347559 domagkd@uni-muenster.de
Contact: Philipp Lenz, M.D. +492518345089 Lenz.Philipp@ukmuenster.de
Principal Investigator: Dirk Domagk, M.D., PhD
Sub-Investigator: Philipp Lenz, M.D.
HELIOS Albert-Schweitzer-Hospital	Recruiting
Northeim, Germany, 37154
Contact: Tobias Meister, M.D. +4915127570032 tobiasmeister@gmx.de
Sub-Investigator: Tobias Meister, M.D.
Italy
Gastroenterology and Digestive Endoscopy Unit, Nuovo Ospedale Civile S.Agostino-Estense	Recruiting
Baggiovara di Modena, Italy, 41126
Contact: Manno Mauro, MD +39 059 3962215 mauromanno75@gmail.com
Sub-Investigator: Mauro Manno, MD
San Giovanni Battista University Teaching Hospital, Department of Medicine, Division of Gastroenterology 2	Recruiting
Torino, Italy, 10123
Contact: Marco Pennazio, MD +39 011 6333918 pennazio.marco@gmail.com
Sub-Investigator: Marco Pennazio, MD

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:

Yamamoto H, Sekine Y, Sato Y, Higashizawa T, Miyata T, Iino S, Ido K, Sugano K. Total enteroscopy with a nonsurgical steerable double-balloon method. Gastrointest Endosc. 2001 Feb;53(2):216-20.

Hartmann D, Eickhoff A, Tamm R, Riemann JF. Balloon-assisted enteroscopy using a single-balloon technique. Endoscopy. 2007 Feb;39 Suppl 1:E276. Epub 2007 Oct 24. No abstract available.

Tsujikawa T, Saitoh Y, Andoh A, Imaeda H, Hata K, Minematsu H, Senoh K, Hayafuji K, Ogawa A, Nakahara T, Sasaki M, Fujiyama Y. Novel single-balloon enteroscopy for diagnosis and treatment of the small intestine: preliminary experiences. Endoscopy. 2008 Jan;40(1):11-5. Epub 2007 Dec 4.

Domagk D, Mensink P, Aktas H, Lenz P, Meister T, Luegering A, Ullerich H, Aabakken L, Heinecke A, Domschke W, Kuipers E, Bretthauer M. Single- vs. double-balloon enteroscopy in small-bowel diagnostics: a randomized multicenter trial. Endoscopy. 2011 Jun;43(6):472-6. Epub 2011 Mar 7. Erratum in: Endoscopy. 2011 Dec;43(12):1089.

Hussein AM, Bartram CI, Williams CB. Carbon dioxide insufflation for more comfortable colonoscopy. Gastrointest Endosc. 1984 Apr;30(2):68-70.

Bretthauer M, Thiis-Evensen E, Huppertz-Hauss G, Gisselsson L, Grotmol T, Skovlund E, Hoff G. NORCCAP (Norwegian colorectal cancer prevention): a randomised trial to assess the safety and efficacy of carbon dioxide versus air insufflation in colonoscopy. Gut. 2002 May;50(5):604-7.

Stevenson GW, Wilson JA, Wilkinson J, Norman G, Goodacre RL. Pain following colonoscopy: elimination with carbon dioxide. Gastrointest Endosc. 1992 Sep-Oct;38(5):564-7.

Sumanac K, Zealley I, Fox BM, Rawlinson J, Salena B, Marshall JK, Stevenson GW, Hunt RH. Minimizing postcolonoscopy abdominal pain by using CO(2) insufflation: a prospective, randomized, double blind, controlled trial evaluating a new commercially available CO(2) delivery system. Gastrointest Endosc. 2002 Aug;56(2):190-4.

Domagk D, Bretthauer M, Lenz P, Aabakken L, Ullerich H, Maaser C, Domschke W, Kucharzik T. Carbon dioxide insufflation improves intubation depth in double-balloon enteroscopy: a randomized, controlled, double-blind trial. Endoscopy. 2007 Dec;39(12):1064-7.

Hirai F, Beppu T, Nishimura T, Takatsu N, Ashizuka S, Seki T, Hisabe T, Nagahama T, Yao K, Matsui T, Beppu T, Nakashima R, Inada N, Tajiri E, Mitsuru H, Shigematsu H. Carbon dioxide insufflation compared with air insufflation in double-balloon enteroscopy: a prospective, randomized, double-blind trial. Gastrointest Endosc. 2011 Apr;73(4):743-9. Epub 2011 Jan 14.

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:	September 26, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 23, 2013