CO2 Versus Air Insufflation for Single-balloon Enteroscopy

NCT01758900 | Completed Phase 4 Results

• 1 other identifier: rjer2011-70k
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation Depth

Keywords

Single-Balloon Enteroscopy

Outcome Measures

Primary Outcomes (1)

• Intubation Depth

  Within 5 minutes after the examination

Secondary Outcomes (6)

• Total Enteroscopy Rate

  Within 1 week after all the examinations are finished

• Diagnostic Rate

  Within 1 week after all the examinations are finished

• Patient's Acceptability

  6 hours after the examination

• Procedure Time

  Within 5 minutes after the examination

• Abdominal Circumference

  10 minutes before/after the examination

Study Arms (2)

Air insufflation regulator

ACTIVE COMPARATOR

Room air will be used for insufflation as the Active Comparator arm

Device: Air insufflation

CO2 insufflation regulator

EXPERIMENTAL

Device: CO2 insufflation regulator

Device: CO2 insufflation regulator

Interventions

CO2 insufflation regulator DEVICE

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.

CO2 insufflation regulator

Air insufflation DEVICE

The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.

Air insufflation regulator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients referred for SBE at the trial centre

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhizheng Ge: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (13)

• 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

• Kawamura T, Yasuda K, Tanaka K, Uno K, Ueda M, Sanada K, Nakajima M. Clinical evaluation of a newly developed single-balloon enteroscope. Gastrointest Endosc. 2008 Dec;68(6):1112-6. doi: 10.1016/j.gie.2008.03.1063. Epub 2008 Jul 2.

  PMID: 18599052 BACKGROUND

• Frantz DJ, Dellon ES, Grimm IS, Morgan DR. Single-balloon enteroscopy: results from an initial experience at a U.S. tertiary-care center. Gastrointest Endosc. 2010 Aug;72(2):422-6. doi: 10.1016/j.gie.2010.03.1117. Epub 2010 Jun 11.

  PMID: 20541189 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

• Dellon ES, Hawk JS, Grimm IS, Shaheen NJ. The use of carbon dioxide for insufflation during GI endoscopy: a systematic review. Gastrointest Endosc. 2009 Apr;69(4):843-9. doi: 10.1016/j.gie.2008.05.067. Epub 2009 Jan 18.

  PMID: 19152906 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

• May A, Farber M, Aschmoneit I, Pohl J, Manner H, Lotterer E, Moschler O, Kunz J, Gossner L, Monkemuller K, Ell C. Prospective multicenter trial comparing push-and-pull enteroscopy with the single- and double-balloon techniques in patients with small-bowel disorders. Am J Gastroenterol. 2010 Mar;105(3):575-81. doi: 10.1038/ajg.2009.712. Epub 2010 Jan 5.

  PMID: 20051942 BACKGROUND

• Iddan G, Meron G, Glukhovsky A, Swain P. Wireless capsule endoscopy. Nature. 2000 May 25;405(6785):417. doi: 10.1038/35013140. No abstract available.

  PMID: 10839527 BACKGROUND

• 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

• Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Rao GV, Darisetty S. Diagnostic yield and therapeutic impact of single-balloon enteroscopy: series of 106 cases. J Gastroenterol Hepatol. 2009 Oct;24(10):1631-8. doi: 10.1111/j.1440-1746.2009.05936.x. Epub 2009 Aug 3.

  PMID: 19686408 BACKGROUND

• Aktas H, de Ridder L, Haringsma J, Kuipers EJ, Mensink PB. Complications of single-balloon enteroscopy: a prospective evaluation of 166 procedures. Endoscopy. 2010 May;42(5):365-8. doi: 10.1055/s-0029-1243931. Epub 2010 Feb 22.

  PMID: 20178072 BACKGROUND

• Upchurch BR, Sanaka MR, Lopez AR, Vargo JJ. The clinical utility of single-balloon enteroscopy: a single-center experience of 172 procedures. Gastrointest Endosc. 2010 Jun;71(7):1218-23. doi: 10.1016/j.gie.2010.01.012. Epub 2010 Apr 20.

  PMID: 20409544 BACKGROUND

• Li X, Zhao YJ, Dai J, Li XB, Xue HB, Zhang Y, Xiong GS, Ohtsuka K, Gao YJ, Liu Q, Song Y, Fang JY, Ge ZZ. Carbon dioxide insufflation improves the intubation depth and total enteroscopy rate in single-balloon enteroscopy: a randomised, controlled, double-blind trial. Gut. 2014 Oct;63(10):1560-5. doi: 10.1136/gutjnl-2013-306069. Epub 2014 Mar 13.

  PMID: 24626435 DERIVED

MeSH Terms

Interventions

Pneumoradiography

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Zhizheng Ge, MD. Ph.D. Director of the Clinical Trials
• Organization: Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

zhizhengge@yahoo.com.cn

86-21-68383015

Study Officials

• Zhizheng Ge, Ph.D. MD.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: January 1, 2013
• Study Start: July 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 25, 2016
• Results First Posted: July 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)