Gastrointestinal HemorrhageNCT00153686
Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding (GIB) of Obscure Origin
A study testing capsule endoscopy and Mesenteric Angiogram in people with Gastrointestinal Hemorrhage, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To compare the diagnostic yield of mesenteric angiogram with CE in patients with active obscure GIB. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- capsule endoscopy and Mesenteric Angiogram
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- Jun 2005to Mar 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to PWH medical or surgical wards with melena or hematochezia in whom OGD and colonoscopy fail to identify site of bleeding.
- Normal or non-diagnostic OGD and colonoscopy
- Informed consent
- Patients presented with shock will be resuscitated for urgent endoscopy
Who cannot join
- Patients remained in shock despite resuscitation.
- Moribund patients
- Terminal malignancy
- Presence of pacemaker or ICD
- Suspected or confirmed intestinal obstruction
- Swallowing difficulties
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- Renal failure that preclude angiographic examination
- Pregnancy
- Age <18
- Refused consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding of Obscure Origin: A Randomized Study
To compare the diagnostic yield of mesenteric angiogram with CE in patients with active obscure GIB.
Read the detailed description
Gastrointestinal bleeding (GIB) of obscure origin is a common conditions resulting in recurrent hospitalization and extensive investigations. Mesenteric angiogram is one of the standard radiological investigations for GIB of obscure origin, and its diagnostic yield ranged from 40-80%. Capsule endoscopy (CE) is a newly available investigation for small bowel examination, especially in bleeding of obscure origin. The diagnostic yield is particularly high in patients with ongoing bleeding. This is a prospective randomized study to compare the diagnostic yield of mesenteric angiogram with CE in patients with overt GIB of obscure origin. The results will help to define the optimal management strategy for this group of patients.
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- capsule endoscopy, Mesenteric Angiogram
- Keywords
- Capsule Endoscopy, Mesenteric angiogram
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsule endoscopyProcedure or surgery
capsule endoscopy of small intestine
Mesenteric AngiogramProcedure or surgery
Mesenteric Angiogram
| Study group | Role | What they receive |
|---|---|---|
| Capsule Endoscopy | Experimental | Capsule Endoscopy examination of small intestine Receives: Procedure: capsule endoscopy |
| Mesenteric Angiogram | Other | Mesenteric Angiogram of the small intestine Receives: Procedure: Mesenteric Angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.
Measured: 12 months
Secondary outcomes (1)
Percentage of patients with definitive diagnoses achieved;Length of stay (days) ;Transfusion requirements;No. of additional investigations (endoscopies, radiological investigation, CE etc);No. of patients requiring surgery ;12-month rebleeding rate
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 posted12 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionNov 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Wai K Leung, MD, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153686
- Sponsor's protocol ID
- CE_Ang
- Status last verified
- May 2008
- First submitted
- 8 Sep 2005
- Last updated
- 13 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding of Obscure Origin: A Randomized Study
- ClinicalTrials.gov ID
- NCT00153686
- Acronym / sponsor ID
- CE_Ang
- Conditions
- Gastrointestinal Hemorrhage
- Keywords
- Capsule Endoscopy, Mesenteric angiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Sep 2005 (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.
To compare the diagnostic yield of mesenteric angiogram with CE in patients with active obscure GIB.
Detailed description
Gastrointestinal bleeding (GIB) of obscure origin is a common conditions resulting in recurrent hospitalization and extensive investigations. Mesenteric angiogram is one of the standard radiological investigations for GIB of obscure origin, and its diagnostic yield ranged from 40-80%. Capsule endoscopy (CE) is a newly available investigation for small bowel examination, especially in bleeding of obscure origin. The diagnostic yield is particularly high in patients with ongoing bleeding. This is a prospective randomized study to compare the diagnostic yield of mesenteric angiogram with CE in patients with overt GIB of obscure origin. The results will help to define the optimal management strategy for this group of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsule Endoscopy | Experimental | Procedure: capsule endoscopyCapsule Endoscopy examination of small intestine |
| Mesenteric Angiogram | Other | Procedure: Mesenteric AngiogramMesenteric Angiogram of the small intestine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients admitted to PWH medical or surgical wards with melena or hematochezia in whom OGD and colonoscopy fail to identify site of bleeding.
- Normal or non-diagnostic OGD and colonoscopy
- Informed consent
- Patients presented with shock will be resuscitated for urgent endoscopy
Key exclusion criteria (10 listed)
- Patients remained in shock despite resuscitation.
- Moribund patients
- Terminal malignancy
- Presence of pacemaker or ICD
- Suspected or confirmed intestinal obstruction
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 |
|---|---|---|
| capsule endoscopycapsule endoscopy of small intestine | Procedure or surgery | Capsule Endoscopy |
| Mesenteric AngiogramMesenteric Angiogram | Procedure or surgery | Mesenteric Angiogram |
Primary outcome
Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.
Time frame: 12 months
1 secondary outcome
Percentage of patients with definitive diagnoses achieved;Length of stay (days) ;Transfusion requirements;No. of additional investigations (endoscopies, radiological investigation, CE etc);No. of patients requiring surgery ;12-month rebleeding rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2008.
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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.
Wai K Leung, MD principal investigator
CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capsule endoscopy and Mesenteric Angiogram in people with Gastrointestinal Hemorrhage, run by Chinese University of Hong Kong 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 4 inclusion and 10 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 13 May 2008. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy. (time frame: 12 months). 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 13 May 2008.