Obscure Gastrointestinal BleedingNCT02315404
Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial
A study testing CAP in people with Obscure Gastrointestinal Bleeding, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Obscure Gastrointestinal Bleeding
- What is being tested?
- CAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 31 May 2017
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years old) patients undergoing BAE for the evaluation of OGIB or iron deficiency anemia.
Who cannot join
- Unable to provide written informed consent.
- Pregnancy or lactation.
- Suspected bowel obstruction or GI perforation.
- Unable to tolerate sedation or general anesthesia due to medical co-morbidities.
- Uncorrected coagulopathy (platelet count <50,000, INR> 2, PTT> 2x upper limit of normal).
- Patient undergoing retrograde BAE.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St Louis
St Louis, Missouri, 63110
About this study
Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to limited visualization of the small bowel lining during conventional endoscopy. One way to improve visualization of the small bowel lining is by adding a transparent plastic cap to the end of the endoscope (camera), which allows the endoscope to see around sharp turned and behind folds in the small bowel.
The investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. The investigators will invite patients referred for BAE to participate in the study; the alternative to participating in the study is having standard BAE (without a cap). If patients choose to participate in the study they will be randomized to BAE with or without a cap on the end of the endoscope. Subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.
- Conditions
- Obscure Gastrointestinal Bleeding
- Being tested
- CAP
- Keywords
- Obscure gastrointestinal bleeding, Overt gastrointestinal bleeding, Occult gastrointestinal bleeding, Enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPProcedure or surgery
CAP fitted to the end of the endoscope
| Study group | Role | What they receive |
|---|---|---|
| No cap | Placebo comparator | enteroscopy performed without a cap Receives: Procedure: CAP |
| Enteroscopy with a cap | Active comparator | Enteroscopy performed with a CAP fitted to the end of the scope Receives: Procedure: CAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of BAE vs. Cap assisted BAE (C-BAE).
Diagnostic yield defined as proportion of enteroscopies in which clinically significant findings were identified.
- Clinically significant findings being defined as P2 lesion (lesion considered to have high potential for bleeding; such as typical angiomata, large ulceration, tumor or varices)
Measured: 1 day
Secondary outcomes (5)
Overall Diagnostic yield of BAE vs. C-BAE
Diagnostic yield defined as proportion of enteroscopies in which any abnormality is detected.
- Abnormalities classified as: i. P0: lesion with no bleeding potential, including visible submucosal veins, diverticula without the presence of blood or nodules without mucosal break. ii. P1: lesion considered as having uncertain bleeding potential, such as a red spot on the intestinal mucosa or small erosions. iii. P2: lesion considered to have high potential for bleeding; such as typical angiomata, large ulceration, tumor or varices
Measured: 1 day
Therapeutic yield BAE vs. Cap assisted BAE (C-BAE).
Therapeutic yield being defined as proportion of enteroscopies in which a therapeutic intervention was undertaken. Interventions included in this calculation were polypectomy, argon plasma coagulation, bipolar coagulation, dilation of strictures, and endoscopic clipping. Biopsy was considered to be a therapeutic intervention if histopathology results lead to the initiation of a medical or surgical therapy (i.e: resection of mass, medical therapy for Crohn's disease)
Measured: 1 day
iii. Depth of small bowel insertion: calculated according to the method of Efthymiou et al.
Fold counting method: The number of complete folds (valvulae conniventes) will be counted during withdrawal of the endoscope; with the assumption that the distance between folds is approximately 0.9 cm.
Measured: 1 day
vProcedure related adverse events.
Measured: 1 day
Recurrence of GI bleeding at 12 months, as evaluated by questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startJan 2014
- Primary completion31 May 2017
- Study completion31 May 2017
Why it stopped: Poor Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obscure Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315404
- Sponsor's protocol ID
- SBE CAP 1
- Status last verified
- Jun 2018
- First submitted
- 6 Jan 2014
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02315404
- Acronym / sponsor ID
- SBE CAP 1
- Conditions
- Obscure Gastrointestinal Bleeding
- Keywords
- Obscure gastrointestinal bleeding, Overt gastrointestinal bleeding, Occult gastrointestinal bleeding, Enteroscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor Enrollment
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 11 Dec 2014 (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.
Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to limited visualization of the small bowel lining during conventional endoscopy. One way to improve visualization of the small bowel lining is by adding a transparent plastic cap to the end of the endoscope (camera), which allows the endoscope to see around sharp turned and behind folds in the small bowel.
The investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. The investigators will invite patients referred for BAE to participate in the study; the alternative to participating in the study is having standard BAE (without a cap). If patients choose to participate in the study they will be randomized to BAE with or without a cap on the end of the endoscope. Subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No cap | Placebo comparator | Procedure: CAPenteroscopy performed without a cap |
| Enteroscopy with a cap | Active comparator | Procedure: CAPEnteroscopy performed with a CAP fitted to the end of the scope |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (≥18 years old) patients undergoing BAE for the evaluation of OGIB or iron deficiency anemia.
Key exclusion criteria (6 listed)
- Unable to provide written informed consent.
- Pregnancy or lactation.
- Suspected bowel obstruction or GI perforation.
- Unable to tolerate sedation or general anesthesia due to medical co-morbidities.
- Uncorrected coagulopathy (platelet count <50,000, INR> 2, PTT> 2x upper limit of normal).
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 |
|---|---|---|
| CAPCAP fitted to the end of the endoscope | Procedure or surgery | Enteroscopy with a cap, No cap |
Primary outcome
Diagnostic yield of BAE vs. Cap assisted BAE (C-BAE).
Time frame: 1 day
Diagnostic yield defined as proportion of enteroscopies in which clinically significant findings were identified. a. Clinically significant findings being defined as P2 lesion (lesion considered to have high potential for bleeding; such as typical angiomata, large ulceration, tumor or varices)
5 secondary outcomes
Overall Diagnostic yield of BAE vs. C-BAE
Time frame: 1 day
Therapeutic yield BAE vs. Cap assisted BAE (C-BAE).
Time frame: 1 day
iii. Depth of small bowel insertion: calculated according to the method of Efthymiou et al.
Time frame: 1 day
vProcedure related adverse events.
Time frame: 1 day
Recurrence of GI bleeding at 12 months, as evaluated by questionnaire
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Poor Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
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RecruitingObservational study
Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAP in people with Obscure Gastrointestinal Bleeding, run by Washington University School of Medicine at 1 site in United States.
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 25 Jun 2018. 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 United States. 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. Some participants in this study may receive a placebo. 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: Poor Enrollment). 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?
Diagnostic yield of BAE vs. Cap assisted BAE (C-BAE). (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2018.