Esophageal and Gastric VaricesNCT00475592
Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy
A study testing Esophageal Capsule Endoscopy and Upper Gastrointestinal Endoscopy in people with Esophageal and Gastric Varices, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal and Gastric Varices
- What is being tested?
- Esophageal Capsule Endoscopy and Upper Gastrointestinal Endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced cirrhosis with portal hypertension based on imaging, clinical suspicion, or liver biopsy
- Age greater than or equal to 18 years old
- Able to give consent
Who cannot join
- Current implantable cardioverter-defibrillators or pacemaker in place
- Suspected intestinal obstruction
- Esophageal swallowing disorder
- Esophageal stenosis
- Age less than 18 years old
- Pregnancy
- Known Zenker's diverticulum
- Patients with previous endoscopic or surgical esophageal treatment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis.
Read the detailed description
Up to 35% of patients with cirrhosis will develop esophageal varices, which carry with them a 1-year and 3-year bleeding rate of 33% and 41%, respectively. Screening for varices with a video endoscopy is limited by its cost, patient compliance, and the risks of sedating a patient with portal hypertension. Capsule endoscopy is a novel method that may reduce the costs and increase compliance for screening.
The investigators propose to screen 100 consecutive patients with advanced cirrhosis for esophageal varices. A capsule endoscopy and video endoscopy will be done on the same day. The varices seen on video endoscopy will be graded using a standard grading scale. Both capsule and video endoscopy images will be assessed in a blinded fashion by 4 independent investigators. Finally, the video endoscopic images will be compared to capsule endoscopy to develop a capsule endoscopy grading system that corresponds to video endoscopy.
The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. Secondary endpoints of the study include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance as assessed on a visual analogue scale; and a cost comparison (facility fees + professional fees) of the two screening methods.
- Conditions
- Esophageal and Gastric Varices
- Being tested
- Esophageal Capsule Endoscopy, Upper Gastrointestinal Endoscopy
- Keywords
- Esophageal Varices, Gastric Varices, Capsule Endoscopy, Portal Hypertension, Cirrhosis, Gastrointestinal Hemorrhage
- Medical subject headings
- Esophageal and Gastric Varices, Hypertension, Portal, Fibrosis, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal Capsule EndoscopyDevice
Upper Gastrointestinal EndoscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| Capsule Endoscopy | Experimental | Not described Receives: Device: Esophageal Capsule Endoscopy |
| Upper Gastrointestinal Endoscopy | Active comparator | Not described Receives: Device: Upper Gastrointestinal Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy.
Measured: Two years
Secondary outcomes (1)
Secondary endpoints include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance; and a cost comparison (facility + professional fees) of the two screening methods.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: study failed to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal and Gastric VaricesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Sponsor
- Investigators
- Paul J Thuluvath, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475592
- Sponsor's protocol ID
- VaricealGrading_EsoCapsule
- Status last verified
- Jul 2017
- First submitted
- 16 May 2007
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT00475592
- Acronym / sponsor ID
- VaricealGrading_EsoCapsule
- Conditions
- Esophageal and Gastric Varices
- Keywords
- Esophageal Varices, Gastric Varices, Capsule Endoscopy, Portal Hypertension, Cirrhosis, Gastrointestinal Hemorrhage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study failed to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- Jan 2007 (actual)
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 21 May 2007 (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 purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis.
Detailed description
Up to 35% of patients with cirrhosis will develop esophageal varices, which carry with them a 1-year and 3-year bleeding rate of 33% and 41%, respectively. Screening for varices with a video endoscopy is limited by its cost, patient compliance, and the risks of sedating a patient with portal hypertension. Capsule endoscopy is a novel method that may reduce the costs and increase compliance for screening.
The investigators propose to screen 100 consecutive patients with advanced cirrhosis for esophageal varices. A capsule endoscopy and video endoscopy will be done on the same day. The varices seen on video endoscopy will be graded using a standard grading scale. Both capsule and video endoscopy images will be assessed in a blinded fashion by 4 independent investigators. Finally, the video endoscopic images will be compared to capsule endoscopy to develop a capsule endoscopy grading system that corresponds to video endoscopy.
The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. Secondary endpoints of the study include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance as assessed on a visual analogue scale; and a cost comparison (facility fees + professional fees) of the two screening methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsule Endoscopy | Experimental | Device: Esophageal Capsule Endoscopy |
| Upper Gastrointestinal Endoscopy | Active comparator | Device: Upper Gastrointestinal Endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced cirrhosis with portal hypertension based on imaging, clinical suspicion, or liver biopsy
- Age greater than or equal to 18 years old
- Able to give consent
Key exclusion criteria (8 listed)
- Current implantable cardioverter-defibrillators or pacemaker in place
- Suspected intestinal obstruction
- Esophageal swallowing disorder
- Esophageal stenosis
- Age less than 18 years old
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 |
|---|---|---|
| Esophageal Capsule Endoscopy | Device | Capsule Endoscopy |
| Upper Gastrointestinal Endoscopy | Device | Upper Gastrointestinal Endoscopy |
Primary outcome
The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy.
Time frame: Two years
1 secondary outcome
Secondary endpoints include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance; and a cost comparison (facility + professional fees) of the two screening methods.
Time frame: Two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Click here for more information about Johns Hopkins Hepatology.Link provided by the sponsor.
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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.
Paul J Thuluvath, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal Capsule Endoscopy and Upper Gastrointestinal Endoscopy in people with Esophageal and Gastric Varices, run by Johns Hopkins University 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 24 Jul 2017. 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. 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 withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. (time frame: Two years). 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 24 Jul 2017.