Colorectal CancerNCT01587872
Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate
A study testing Fujinon EC-450BI5 double-balloon colonoscope in people with Colorectal Cancer and Colorectal Adenomas, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors can make the procedure difficult, and sometimes a complete examination is not possible. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenomas, Inflammatory Bowel Disease
- What is being tested?
- Fujinon EC-450BI5 double-balloon colonoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Failed cecal intubation during conventional colonoscopy due to technical difficulties
Who cannot join
- Failed cecal intubation due to insufficient bowel preparation
- Stenotic colonic lesions
- Patients decline
- Pregnancy
- Persons younger than 18 years
- Persons unable to comprehend the information given
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-balloon Colonoscopy to Increase Cecal Intubation Rate in Technically Difficult Colonoscopies
The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors can make the procedure difficult, and sometimes a complete examination is not possible. Complicating factors include poor bowel preparation and technical challenges such as differences in anatomy (long, redundant colonic segments), post-surgical adhesions, strictures and diverticulosis. A special endoscope with two inflatable balloons, originally designed to examine the small bowel, has been used for several years with success in such technically difficult colonoscopies. More recently a modified double-balloon instrument was designed specifically for colonoscopy, but the documentation of the performance of this instrument is limited. The aim of the present study is to investigate the performance of the double-balloon colonoscope in cases where conventional colonoscopy have failed due to technical difficulties.
Read the detailed description
This is a prospective cohort study to investigate the performance of the test instrument. The test instrument consists of a slim, flexible colonoscope with an overtube and an inflatable balloon on the tip of the colonoscope and the tip of the overtube. Patients are eligible for inclusion if conventional colonoscopy fails due to technical difficulties such as loop formation, long colonic segments or suspected adhesions. Written informed consent is required. The study procedures will be performed immediately after the failed conventional colonoscopy, or on a rescheduled appointment within four weeks.
- Being tested
- Fujinon EC-450BI5 double-balloon colonoscope
- Keywords
- Colonoscopy, Colorectal cancer, Screening colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fujinon EC-450BI5 double-balloon colonoscopeProcedure or surgery
Colonoscopy with the test instrument
| Study group | Role | What they receive |
|---|---|---|
| DBC | Experimental | Double balloon colonoscopy will be attempted in cases where conventional colonoscopy failed due to technical difficulties such as looping or redundant colonic segments. Receives: Procedure: Fujinon EC-450BI5 double-balloon colonoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal intubation rate
The primary outcome measure is a complete or non-complete colonoscopy with the test instrument. Completion is assessed at the end of each procedure.
Measured: 2 hours
Secondary outcomes (1)
Detection of additional colonic pathology
To assess if additional pathology is detected in segments of the colon reached with the test instrument that was not reached with a conventional colonoscope.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Slow patient recruitment, not enough patients willing to participate within the prespecified time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- South-Eastern Norway Regional Health Authority, Fujifilm Europa
- Responsible party
- Sponsor
- Investigators
- Michael Bretthauer, PhD, Study chair, The Cancer Registry of Norway, Oslo University HospitalKjetil K Garborg, MD, Principal investigator, Sorlandet Hospital HF, Kristiansand, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587872
- Sponsor's protocol ID
- SSK_DBC
- Status last verified
- Apr 2012
- First submitted
- 12 Jan 2012
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009 Mar;104(3):739-50. doi: 10.1038/ajg.2009.104. Epub 2009 Feb 24.
PubMed 19240699Neerincx M, Terhaar sive Droste JS, Mulder CJ, Rakers M, Bartelsman JF, Loffeld RJ, Tuynman HA, Brohet RM, van der Hulst RW. Colonic work-up after incomplete colonoscopy: significant new findings during follow-up. Endoscopy. 2010 Sep;42(9):730-5. doi: 10.1055/s-0030-1255523. Epub 2010 Jul 28.
PubMed 20669092Yamamoto H, Kita H. Enteroscopy. J Gastroenterol. 2005 Jun;40(6):555-62. doi: 10.1007/s00535-005-1645-5.
PubMed 16007388Moreels TG, Macken EJ, Roth B, Van Outryve MJ, Pelckmans PA. Cecal intubation rate with the double-balloon endoscope after incomplete conventional colonoscopy: a study in 45 patients. J Gastroenterol Hepatol. 2010 Jan;25(1):80-3. doi: 10.1111/j.1440-1746.2009.05942.x. Epub 2009 Aug 3.
PubMed 19686405Monkemuller K, Knippig C, Rickes S, Fry LC, Schulze A, Malfertheiner P. Usefulness of the double-balloon enteroscope in colonoscopies performed in patients with previously failed colonoscopy. Scand J Gastroenterol. 2007 Feb;42(2):277-8. doi: 10.1080/00365520600802785. No abstract available.
PubMed 17327949Pasha SF, Harrison ME, Das A, Corrado CM, Arnell KN, Leighton JA. Utility of double-balloon colonoscopy for completion of colon examination after incomplete colonoscopy with conventional colonoscope. Gastrointest Endosc. 2007 May;65(6):848-53. doi: 10.1016/j.gie.2006.08.046. Epub 2007 Feb 26.
PubMed 17324408Kaltenbach T, Soetikno R, Friedland S. Use of a double balloon enteroscope facilitates caecal intubation after incomplete colonoscopy with a standard colonoscope. Dig Liver Dis. 2006 Dec;38(12):921-5. doi: 10.1016/j.dld.2006.08.003. Epub 2006 Sep 20.
PubMed 16990055Gay G, Delvaux M. Double-balloon colonoscopy after failed conventional colonoscopy: a pilot series with a new instrument. Endoscopy. 2007 Sep;39(9):788-92. doi: 10.1055/s-2007-966753.
PubMed 17703387
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-balloon Colonoscopy to Increase Cecal Intubation Rate in Technically Difficult Colonoscopies
- ClinicalTrials.gov ID
- NCT01587872
- Acronym / sponsor ID
- SSK_DBC
- Keywords
- Colonoscopy, Colorectal cancer, Screening colonoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow patient recruitment, not enough patients willing to participate within the prespecified time frame.
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- South-Eastern Norway Regional Health Authority, Fujifilm Europa
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors can make the procedure difficult, and sometimes a complete examination is not possible. Complicating factors include poor bowel preparation and technical challenges such as differences in anatomy (long, redundant colonic segments), post-surgical adhesions, strictures and diverticulosis. A special endoscope with two inflatable balloons, originally designed to examine the small bowel, has been used for several years with success in such technically difficult colonoscopies. More recently a modified double-balloon instrument was designed specifically for colonoscopy, but the documentation of the performance of this instrument is limited. The aim of the present study is to investigate the performance of the double-balloon colonoscope in cases where conventional colonoscopy have failed due to technical difficulties.
Detailed description
This is a prospective cohort study to investigate the performance of the test instrument. The test instrument consists of a slim, flexible colonoscope with an overtube and an inflatable balloon on the tip of the colonoscope and the tip of the overtube. Patients are eligible for inclusion if conventional colonoscopy fails due to technical difficulties such as loop formation, long colonic segments or suspected adhesions. Written informed consent is required. The study procedures will be performed immediately after the failed conventional colonoscopy, or on a rescheduled appointment within four weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBC | Experimental | Procedure: Fujinon EC-450BI5 double-balloon colonoscopeDouble balloon colonoscopy will be attempted in cases where conventional colonoscopy failed due to technical difficulties such as looping or redundant colonic segments. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Failed cecal intubation during conventional colonoscopy due to technical difficulties
Key exclusion criteria (6 listed)
- Failed cecal intubation due to insufficient bowel preparation
- Stenotic colonic lesions
- Patients decline
- Pregnancy
- Persons younger than 18 years
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 |
|---|---|---|
| Fujinon EC-450BI5 double-balloon colonoscopeColonoscopy with the test instrument | Procedure or surgery | DBC |
Primary outcome
Cecal intubation rate
Time frame: 2 hours
The primary outcome measure is a complete or non-complete colonoscopy with the test instrument. Completion is assessed at the end of each procedure.
1 secondary outcome
Detection of additional colonic pathology
Time frame: 2 hours
Results and safety
The study was stopped early (reason given: Slow patient recruitment, not enough patients willing to participate within the prespecified time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Background: PubMed 19240699Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009 Mar;104(3):739-50. doi: 10.1038/ajg.2009.104. Epub 2009 Feb 24.
- Background: PubMed 20669092Neerincx M, Terhaar sive Droste JS, Mulder CJ, Rakers M, Bartelsman JF, Loffeld RJ, Tuynman HA, Brohet RM, van der Hulst RW. Colonic work-up after incomplete colonoscopy: significant new findings during follow-up. Endoscopy. 2010 Sep;42(9):730-5. doi: 10.1055/s-0030-1255523. Epub 2010 Jul 28.
- Background: PubMed 16007388Yamamoto H, Kita H. Enteroscopy. J Gastroenterol. 2005 Jun;40(6):555-62. doi: 10.1007/s00535-005-1645-5.
- Background: PubMed 19686405Moreels TG, Macken EJ, Roth B, Van Outryve MJ, Pelckmans PA. Cecal intubation rate with the double-balloon endoscope after incomplete conventional colonoscopy: a study in 45 patients. J Gastroenterol Hepatol. 2010 Jan;25(1):80-3. doi: 10.1111/j.1440-1746.2009.05942.x. Epub 2009 Aug 3.
- Background: PubMed 17327949Monkemuller K, Knippig C, Rickes S, Fry LC, Schulze A, Malfertheiner P. Usefulness of the double-balloon enteroscope in colonoscopies performed in patients with previously failed colonoscopy. Scand J Gastroenterol. 2007 Feb;42(2):277-8. doi: 10.1080/00365520600802785. No abstract available.
- Background: PubMed 17324408Pasha SF, Harrison ME, Das A, Corrado CM, Arnell KN, Leighton JA. Utility of double-balloon colonoscopy for completion of colon examination after incomplete colonoscopy with conventional colonoscope. Gastrointest Endosc. 2007 May;65(6):848-53. doi: 10.1016/j.gie.2006.08.046. Epub 2007 Feb 26.
- Background: PubMed 16990055Kaltenbach T, Soetikno R, Friedland S. Use of a double balloon enteroscope facilitates caecal intubation after incomplete colonoscopy with a standard colonoscope. Dig Liver Dis. 2006 Dec;38(12):921-5. doi: 10.1016/j.dld.2006.08.003. Epub 2006 Sep 20.
- Background: PubMed 17703387Gay G, Delvaux M. Double-balloon colonoscopy after failed conventional colonoscopy: a pilot series with a new instrument. Endoscopy. 2007 Sep;39(9):788-92. doi: 10.1055/s-2007-966753.
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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.
Michael Bretthauer, PhD study chair
The Cancer Registry of Norway, Oslo University Hospital
Kjetil K Garborg, MD principal investigator
Sorlandet Hospital HF, Kristiansand, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fujinon EC-450BI5 double-balloon colonoscope in people with Colorectal Cancer and Colorectal Adenomas, run by Sorlandet Hospital HF at 1 site in Norway.
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 6 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: stopped early, as of the sponsor's last update on 14 Apr 2014. 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 Norway. 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.
Are results available for this study?
The study was stopped early (reason given: Slow patient recruitment, not enough patients willing to participate within the prespecified time frame.). Results are not available in the source record.
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?
Cecal intubation rate (time frame: 2 hours). 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 NCT01587872, which also lists 8 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 14 Apr 2014.