Intubation DepthPhase 4NCT01758900

CO2 Versus Air Insufflation for Single-balloon Enteroscopy

A Phase 4 study testing CO2 insufflation regulator and Air insufflation in people with Intubation Depth, run by Zhizheng Ge at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Intubation Depth
What is being tested?: CO2 insufflation regulator and Air insufflation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 214 participants
Where: 1 siteChina
Study dates: Jul 2011to May 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients referred for SBE at the trial centre

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127

Other trials in China

About this study

Official title: CO2 Versus Air Insufflation for Single-balloon Enteroscopy: a Randomized, Controlled Trial

Read the detailed description

Currently, air is more frequently used to insufflate gas into the lumen to ensure the visualization of the mucosa. However, there're some limitations, for instance, significant amounts of air are usually retained in the small bowel, which will lead to the distention and the pain of the gastrointestinal tract during and after the procedure.

Carbon dioxide(CO2), comparing to the air, is rapidly absorbed from the intestine, which allows the bowel to decompress more quickly and potentially decreases intraprocedural and postprocedural pain, sedation medication requirements, procedure time, and recovery time. It is also to the benefit of deeper intubation depth so that higher total enteroscopy rate and diagnostic rate will be achieved.

Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP and DBE examination, but it is still uncertain to the SBE procedure

Conditions: Intubation Depth
Being tested: CO2 insufflation regulator, Air insufflation
Keywords: Single-Balloon Enteroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CO2 insufflation regulatorDevice
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.
Air insufflationDevice
The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.

Study groups in NCT01758900
Study group	Role	What they receive
Air insufflation regulator	Active comparator	Room air will be used for insufflation as the Active Comparator arm Receives: Device: Air insufflation
CO2 insufflation regulator	Experimental	Device: CO2 insufflation regulator Receives: Device: CO2 insufflation regulator

What is being measured

The primary outcome is the main question the study is designed to answer.

Intubation Depth
Measured: Within 5 minutes after the examination

Secondary outcomes (6)

Total Enteroscopy Rate
Measured: Within 1 week after all the examinations are finished
Diagnostic Rate
Measured: Within 1 week after all the examinations are finished
Patient's Acceptability
Acceptability was recorded on a questionnaire given to patients after the examination. Patients assessed the degree of abdominal pain/distention along a 10-cm line of the VAS(visual analogue scale), with the 0-cm point labeled "no pain/distention" on left end and the 10-cm point labeled "very severe pain/distention that cannot be tolerated" on the right end. Patients were asked to score the severity of pain/distention experienced at 1, 2, 3 and 6 hours after the completion of the entire examination.
Measured: 6 hours after the examination
Procedure Time
Measured: Within 5 minutes after the examination
Abdominal Circumference
To measure abdominal circumference, a tape was placed horizontally around the abdomen at the level of the middle location between the level of anterior superior iliac spine and the lower edge of costal arch, and the measurement was made at the end of a normal expiration before and after the procedure.
Measured: 10 minutes before/after the examination
Complication Rate
Measured: Within 1 week after all the examinations are finished

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011May 2013

First posted1 Jan 2013 (estimated)
Study startJul 2011
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Intubation DepthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 214 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01758900
Sponsor's protocol ID: rjer2011-70k
Status last verified: Oct 2016
First submitted: 18 Dec 2012
Last updated: 25 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 18058613
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.
PubMed 18599052
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.
PubMed 20541189
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.
PubMed 18072057
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.
PubMed 19152906
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.
PubMed 21237455
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.
PubMed 20051942
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.
PubMed 10839527
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.
PubMed 11174299
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.
PubMed 19686408
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.
PubMed 20178072
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.
PubMed 20409544
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.
PubMed 24626435

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intubation Depth trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CO2 Versus Air Insufflation for Single-balloon Enteroscopy: a Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT01758900
Acronym / sponsor ID: rjer2011-70k
Conditions: Intubation Depth
Keywords: Single-Balloon Enteroscopy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 214 participants (actual)
Lead sponsor: Zhizheng GeUniversity, hospital or other
Study start: Jul 2011
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 1 Jan 2013 (estimated)
Results: Posted 14 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP and DBE examination, but it is still uncertain to the SBE procedure

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Air insufflation regulator	Active comparator	Device: Air insufflationRoom air will be used for insufflation as the Active Comparator arm
CO2 insufflation regulator	Experimental	Device: CO2 insufflation regulatorDevice: CO2 insufflation regulator

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

patients referred for SBE at the trial centre

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CO2 insufflation regulatorThe 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.	Device	CO2 insufflation regulator
Air insufflationThe air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.	Device	Air insufflation regulator

Primary outcome

Intubation Depth
Time frame: Within 5 minutes after the examination

6 secondary outcomes

Total Enteroscopy Rate
Time frame: Within 1 week after all the examinations are finished
Diagnostic Rate
Time frame: Within 1 week after all the examinations are finished
Patient's Acceptability
Time frame: 6 hours after the examination
Procedure Time
Time frame: Within 5 minutes after the examination
Abdominal Circumference
Time frame: 10 minutes before/after the examination
Complication Rate
Time frame: Within 1 week after all the examinations are finished

Results and safety

Results posted to the registry on 14 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CO2(Carbon Dioxide) Insufflation Regulator	106	99
Air Insufflation Regulator	108	100

Primary outcome: Intubation Depth

Time frame: Within 5 minutes after the examination. Mean (Standard Deviation). Unit: cm

Measure	CO2 Insufflation Regulator n = 106	Air Insufflation Regulator n = 108
Value	323.8 (64.2)	238.3 (68.6)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event was defined as any event that changed the health status of a patient, occurring within 30 days after enteroscopy examination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CO2 Insufflation Regulator	1 of 106 (0.9%)	0 of 106 (0%)	Not reported
Air Insufflation Regulator	1 of 108 (0.9%)	0 of 108 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18058613Tsujikawa 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.
Background: PubMed 18599052Kawamura 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.
Background: PubMed 20541189Frantz 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.
Background: PubMed 18072057Domagk 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.
Background: PubMed 19152906Dellon 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.
Background: PubMed 21237455Hirai 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.
Background: PubMed 20051942May 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.
Background: PubMed 10839527Iddan G, Meron G, Glukhovsky A, Swain P. Wireless capsule endoscopy. Nature. 2000 May 25;405(6785):417. doi: 10.1038/35013140. No abstract available.
Background: PubMed 11174299Yamamoto 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.
Background: PubMed 19686408Ramchandani 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.
Background: PubMed 20178072Aktas 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.
Background: PubMed 20409544Upchurch 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhizheng Ge, Ph.D. MD. principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CO2 insufflation regulator and Air insufflation in people with Intubation Depth, run by Zhizheng Ge at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intubation Depth (time frame: Within 5 minutes after the examination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01758900, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.