Small-Bowel DisordersPhase 4DBE;SBENCT01176864
Double- Versus Single-balloon Enteroscopy for Obscure Small-bowel Bleeding
A Phase 4 study testing Double-balloon enteroscopy and Single-balloon enteroscopy in people with Small-Bowel Disorders, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
Double-balloon enteroscopy (DBE) is now an established method for diagnostic and therapeutic small-bowel endoscopy. Single-balloon enteroscopy (SBE) has been introduced to simplify the technique. A prospective randomized study was carried out to compare the two methods in obscure small bowel bleeding Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Small-Bowel Disorders
- What is being tested?
- Double-balloon enteroscopy and Single-balloon enteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Jul 2012
- Phase
- Phase 4
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- suspected or known small-bowel bleeding
- age: 16-70
Who cannot join
- pregnancy
- coagulation disorders
- prior surgery of the small bowel and colon
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai changzheng Hospital
Shanghai, Shanghai Municipality, 200003
About this study
Official title: Prospective Trial Comparing Push-and-Pull Enteroscopy With the Single- and Double-Balloon Techniques in Patients With Obscure Small-Bowel Bleeding
Double-balloon enteroscopy (DBE) is now an established method for diagnostic and therapeutic small-bowel endoscopy. Single-balloon enteroscopy (SBE) has been introduced to simplify the technique. A prospective randomized study was carried out to compare the two methods in obscure small bowel bleeding
Read the detailed description
Th e double-balloon enteroscopy (DBE) system, developed by Dr Yamamoto, was presented for the fi rst time in Japan in 2001. The system has become established throughout the world for diagnostic and therapeutic small-bowel examinations, and it is now used universally in routine clinical work.
Another balloon enteroscopy system was recently introduced in which only one balloon is attached at the tip of the overtube; the method is therefore known as SBE. SBE is a simplification of the double balloon method, and its value has already been confirmed for difficult colonoscopies. The question of whether similar results can be achieved with the single balloon method in the more complex situation of the small bowel has not yet been answered.
- Conditions
- Small-Bowel Disorders
- Being tested
- Double-balloon enteroscopy, Single-balloon enteroscopy
- Keywords
- Small-Bowel Disorders, Double-balloon enteroscopy, Single-balloon enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-balloon enteroscopyProcedure or surgery
Double-balloon enteroscopy
Single-balloon enteroscopyProcedure or surgery
Single-balloon enteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Double-balloon enteroscopy | Active comparator | DBE for suspected or known small-bowel bleeding Receives: Procedure: Double-balloon enteroscopy |
| Single-balloon enteroscopy | Active comparator | SBE for suspected or known small-bowel bleeding Receives: Procedure: Single-balloon enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
whether the complete enteroscopy is achieved?
the rate of complete enteroscopy in both groups.
Measured: 2 hours
Secondary outcomes (4)
Preparation time
Measured: 2 hours
Investigation time
Measured: 2 hours
side effects
Measured: 2 days
Diagnostic yield
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 posted6 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Small-Bowel DisordersStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jian Shi, MD, Principal investigator, Shanghai Changzheng HospitalBin Shi, MD, Principal investigator, Shanghai Changzheng HospitalWei-Fen Xie, MD, Study director, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176864
- Sponsor's protocol ID
- ERK-2
- Acronym
- DBE;SBE
- Status last verified
- Jul 2010
- First submitted
- 28 Jul 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 20541189May 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial Comparing Push-and-Pull Enteroscopy With the Single- and Double-Balloon Techniques in Patients With Obscure Small-Bowel Bleeding
- ClinicalTrials.gov ID
- NCT01176864
- Acronym / sponsor ID
- DBE;SBE / ERK-2
- Conditions
- Small-Bowel Disorders
- Keywords
- Small-Bowel Disorders, Double-balloon enteroscopy, Single-balloon enteroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 6 Aug 2010 (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.
Double-balloon enteroscopy (DBE) is now an established method for diagnostic and therapeutic small-bowel endoscopy. Single-balloon enteroscopy (SBE) has been introduced to simplify the technique. A prospective randomized study was carried out to compare the two methods in obscure small bowel bleeding
Detailed description
Th e double-balloon enteroscopy (DBE) system, developed by Dr Yamamoto, was presented for the fi rst time in Japan in 2001. The system has become established throughout the world for diagnostic and therapeutic small-bowel examinations, and it is now used universally in routine clinical work.
Another balloon enteroscopy system was recently introduced in which only one balloon is attached at the tip of the overtube; the method is therefore known as SBE. SBE is a simplification of the double balloon method, and its value has already been confirmed for difficult colonoscopies. The question of whether similar results can be achieved with the single balloon method in the more complex situation of the small bowel has not yet been answered.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-balloon enteroscopy | Active comparator | Procedure: Double-balloon enteroscopyDBE for suspected or known small-bowel bleeding |
| Single-balloon enteroscopy | Active comparator | Procedure: Single-balloon enteroscopySBE for suspected or known small-bowel bleeding |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- suspected or known small-bowel bleeding
- age: 16-70
Key exclusion criteria (3 listed)
- pregnancy
- coagulation disorders
- prior surgery of the small bowel and colon
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 |
|---|---|---|
| Double-balloon enteroscopyDouble-balloon enteroscopy | Procedure or surgery | Double-balloon enteroscopy |
| Single-balloon enteroscopySingle-balloon enteroscopy | Procedure or surgery | Single-balloon enteroscopy |
Primary outcome
whether the complete enteroscopy is achieved?
Time frame: 2 hours
the rate of complete enteroscopy in both groups.
4 secondary outcomes
Preparation time
Time frame: 2 hours
Investigation time
Time frame: 2 hours
side effects
Time frame: 2 days
Diagnostic yield
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2010.
- 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.
- Results publication: 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.
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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.
Jian Shi, MD principal investigator
Shanghai Changzheng Hospital
Bin Shi, MD principal investigator
Shanghai Changzheng Hospital
Wei-Fen Xie, MD study director
Shanghai Changzheng Hospital
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 Double-balloon enteroscopy and Single-balloon enteroscopy in people with Small-Bowel Disorders, run by Shanghai Changzheng Hospital 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Aug 2010. 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?
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?
whether the complete enteroscopy is achieved? (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 NCT01176864, which also lists 2 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 6 Aug 2010; AzTrials last refreshed its copy on 29 Oct 2026.