CO2 Insufflation During Single-Balloon-Enteroscopy

NCT01524055 | Completed Phase 3

• 2 other identifiers: 18052011CO2 Insufflation During SBE
• Study Type: interventional
• Target: 107
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Intubation depth

  The endoscopists estimate the depth of intubation during each examination using a recently described and validated technique.

  2h

Secondary Outcomes (2)

• Number of participants with severe adverse events related to the endoscopic procedure

  48h

• Abdominal pain on on the visual analog scale

  24h

Study Arms (2)

Air

OTHER

Air as insufflation gas during single-balloon enteroscopy.

Device: Single-Balloon-Enteroscopy with Air as insufflation gas.

CO2

OTHER

CO2 as insufflation gas during single-balloon enteroscopy.

Device: Single-Balloon-Enteroscopy with CO2 as insufflation gas.

Interventions

Single-Balloon-Enteroscopy with Air as insufflation gas. DEVICE

Single-Balloon-Enteroscopy will be performed using Air as insufflation gas to inflate the intestine for complete examination.

Also known as: SIF-Q180, Olympus Optical, Tokyo, Japan

Air

Single-Balloon-Enteroscopy with CO2 as insufflation gas. DEVICE

Single-Balloon-Enteroscopy will be performed using CO2 as insufflation gas to inflate the intestine for complete examination.

Also known as: SIF-Q180, Olympus Optical, Tokyo, Japan

CO2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for Single-Balloon-Enteroscopy

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Albert Schweitzer Hospital: collaborator
• Nuovo Ospedale Civile S.Agostino Estense: collaborator
• Azienda Ospedaliera San Giovanni Battista: collaborator

Study Sites (4)

University Hopstial of Muenster, Department of Medicine B

Münster, 48149, Germany

Location

HELIOS Albert-Schweitzer-Hospital

Northeim, 37154, Germany

Location

Gastroenterology and Digestive Endoscopy Unit, Nuovo Ospedale Civile S.Agostino-Estense

Baggiovara Di Modena, 41126, Italy

Location

San Giovanni Battista University Teaching Hospital, Department of Medicine, Division of Gastroenterology 2

Torino, 10123, Italy

Location

Related Publications (11)

• 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. doi: 10.1067/mge.2001.112181.

  PMID: 11174299 BACKGROUND

• Hartmann D, Eickhoff A, Tamm R, Riemann JF. Balloon-assisted enteroscopy using a single-balloon technique. Endoscopy. 2007 Feb;39 Suppl 1:E276. doi: 10.1055/s-2007-966616. Epub 2007 Oct 24. No abstract available.

  PMID: 17957636 BACKGROUND

• 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. doi: 10.1055/s-2007-966976. Epub 2007 Dec 4.

  PMID: 18058613 BACKGROUND

• 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. doi: 10.1055/s-0030-1256247. Epub 2011 Mar 7.

  PMID: 21384320 BACKGROUND

• Hussein AM, Bartram CI, Williams CB. Carbon dioxide insufflation for more comfortable colonoscopy. Gastrointest Endosc. 1984 Apr;30(2):68-70. doi: 10.1016/s0016-5107(84)72319-4.

  PMID: 6425108 BACKGROUND

• 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. doi: 10.1136/gut.50.5.604.

  PMID: 11950803 BACKGROUND

• 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. doi: 10.1016/s0016-5107(92)70517-3.

  PMID: 1397911 BACKGROUND

• 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. doi: 10.1016/s0016-5107(02)70176-4.

  PMID: 12145595 BACKGROUND

• 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. doi: 10.1055/s-2007-966990.

  PMID: 18072057 BACKGROUND

• 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. doi: 10.1016/j.gie.2010.10.003. Epub 2011 Jan 14.

  PMID: 21237455 BACKGROUND

• Lenz P, Meister T, Manno M, Pennazio M, Conigliaro R, Lebkucher S, Ullerich H, Schmedt A, Floer M, Beyna T, Lenze F, Domagk D. CO2 insufflation during single-balloon enteroscopy: a multicenter randomized controlled trial. Endoscopy. 2014 Jan;46(1):53-8. doi: 10.1055/s-0033-1359041. Epub 2013 Dec 18.

  PMID: 24353124 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Single-Balloon Enteroscopy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Balloon Enteroscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Dirk Domagk, M.D., PhD

  Department of Medicine B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: February 1, 2012
• Study Start: December 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

DE (2); IT (2)