Esophageal VaricesNCT01079416
Study of Capsule Endoscopy to Determine the Accuracy for Detection of Esophageal Varices
An observational study of Esophageal Varices, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Esophageal capsule endoscopy is sedation-less alternative to upper endoscopy for evaluating esophageal lesions and potentially other upper gastrointestinal lesions. The purpose of this study was to determine whether esophageal capsule endoscopy is convenient and accurate as upper endoscopy for detection of esophageal… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Varices
- What is being tested?
- Capsule endoscopy, Esophagogastroduodenoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Feb 2008
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhotic patients
Who may be able to join
- Age at least 18 years and less than 86 years at the time of consent.
- Clinically evident or biopsy proven cirrhosis.
- No previous documented UGI bleeding due to peptic ulcers, varices, portal hypertensive gastropathy, angiomas, or watermelon stomach.
- No previous endoscopic, radiological or surgical treatment for variceal bleeding or ascites.
- Probable life expectancy of at least 24 months without liver transplantation, as judged by the hepatologist and endoscopist-investigators, and have a Model for End-Stage Liver Disease (MELD) score ≤ 29.
- Signed a written informed consent.
Who cannot join
- Prior variceal bleeding- esophageal, gastric, or other site.
- Prior endoscopic (e.g. sclerotherapy, ligation, or combination therapy), radiological (e.g. transjugular intrahepatic portosystemic shunt-TIPS) or surgical (e.g. portocaval or splenorenal shunt) treatment of esophagogastric varices or ascites.
- Patient who was uncooperative or unable to give written consent.
- Severe co-morbid illness, e.g. end stage chronic renal disease (e.g. dialysis dependence, creatinine greater than 2 times normal) or respiratory failure (e.g. ventilator dependent, oxygen dependent, unstable asthma or chronic obstructive pulmonary disease- e.g. 2 or more hospitalizations for exacerbation in 1 year, asthma or obstructive pulmonary disease which required daily bronchodilators and/or oral/inhaled steroids), tense ascites requiring repeated therapeutic paracenteses, severe hepatic encephalopathy, peritonitis, or sepsis.
- Active cancer with less than a 24 month expected survival and/or cancer on active treatment with chemotherapy and/or radiation therapy.
- Esophageal motility disorder, esophageal stricture or esophageal diverticulum, causing dysphagia or requiring dilatation.
- GI obstruction or partial obstruction (by history or imaging), symptomatic GI stricture or pseudo-obstruction which may prevent passage of the capsule.
- Patients with potentially reversible portal hypertension such as alcoholic hepatitis, acute viral hepatitis, untreated autoimmune hepatitis, or chronic hepatitis B or C on viral therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Capsule Endoscopy Accurate and Cost-effective Enough to Screen Cirrhotic Patients for Varices & Other Lesions?
Esophageal capsule endoscopy is sedation-less alternative to upper endoscopy for evaluating esophageal lesions and potentially other upper gastrointestinal lesions. The purpose of this study was to determine whether esophageal capsule endoscopy is convenient and accurate as upper endoscopy for detection of esophageal varices and related lesions.
- Conditions
- Esophageal Varices
- Being tested
- Capsule endoscopy, Esophagogastroduodenoscopy
- Keywords
- Esophageal Capsule Endoscopy, Screening
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule endoscopy, EsophagogastroduodenoscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| Capsule endoscopy | Study device Receives: Device: Capsule endoscopy, Esophagogastroduodenoscopy | |
| Esophagogastroduodenoscopy | Gold standard Receives: Device: Capsule endoscopy, Esophagogastroduodenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of capsule endoscopy for detecting esophageal varices
Measured: June 2006-February 2008
Secondary outcomes (1)
Time to perform and interpret capsule endoscopy study
Measured: June 2006-February 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startJun 2006
- Primary completionFeb 2008
- Study completionFeb 2008
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 Esophageal VaricesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Disaya Chavalitdhamrong, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079416
- Sponsor's protocol ID
- 01-11-047-12
- Other IDs
- K24DK002650
- Status last verified
- Jan 2013
- First submitted
- 1 Mar 2010
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Jensen DM. Endoscopic screening for varices in cirrhosis: findings, implications, and outcomes. Gastroenterology. 2002 May;122(6):1620-30. doi: 10.1053/gast.2002.33419.
PubMed 12016427Jutabha R, Jensen DM, Martin P, Savides T, Han SH, Gornbein J. Randomized study comparing banding and propranolol to prevent initial variceal hemorrhage in cirrhotics with high-risk esophageal varices. Gastroenterology. 2005 Apr;128(4):870-81. doi: 10.1053/j.gastro.2005.01.047.
PubMed 15825071
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Capsule Endoscopy Accurate and Cost-effective Enough to Screen Cirrhotic Patients for Varices & Other Lesions?
- ClinicalTrials.gov ID
- NCT01079416
- Acronym / sponsor ID
- 01-11-047-12
- Conditions
- Esophageal Varices
- Keywords
- Esophageal Capsule Endoscopy, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 3 Mar 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.
Esophageal capsule endoscopy is sedation-less alternative to upper endoscopy for evaluating esophageal lesions and potentially other upper gastrointestinal lesions. The purpose of this study was to determine whether esophageal capsule endoscopy is convenient and accurate as upper endoscopy for detection of esophageal varices and related lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsule endoscopy | – | Device: Capsule endoscopy, EsophagogastroduodenoscopyStudy device |
| Esophagogastroduodenoscopy | – | Device: Capsule endoscopy, EsophagogastroduodenoscopyGold standard |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic patients
Key inclusion criteria (6 listed)
- Age at least 18 years and less than 86 years at the time of consent.
- Clinically evident or biopsy proven cirrhosis.
- No previous documented UGI bleeding due to peptic ulcers, varices, portal hypertensive gastropathy, angiomas, or watermelon stomach.
- No previous endoscopic, radiological or surgical treatment for variceal bleeding or ascites.
- Probable life expectancy of at least 24 months without liver transplantation, as judged by the hepatologist and endoscopist-investigators, and have a Model for End-Stage Liver Disease (MELD) score ≤ 29.
Key exclusion criteria (8 listed)
- Prior variceal bleeding- esophageal, gastric, or other site.
- Prior endoscopic (e.g. sclerotherapy, ligation, or combination therapy), radiological (e.g. transjugular intrahepatic portosystemic shunt-TIPS) or surgical (e.g. portocaval or splenorenal shunt) treatment of esophagogastric varices or ascites.
- Patient who was uncooperative or unable to give written consent.
- Severe co-morbid illness, e.g. end stage chronic renal disease (e.g. dialysis dependence, creatinine greater than 2 times normal) or respiratory failure (e.g. ventilator dependent, oxygen dependent, unstable asthma or chronic obstructive pulmonary disease- e.g. 2 or more hospitalizations for exacerbation in 1 year, asthma or obstructive pulmonary disease which required daily bronchodilators and/or oral/inhaled steroids), tense ascites requiring repeated therapeutic paracenteses, severe hepatic encephalopathy, peritonitis, or sepsis.
- Active cancer with less than a 24 month expected survival and/or cancer on active treatment with chemotherapy and/or radiation therapy.
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 endoscopy, Esophagogastroduodenoscopy | Device | Capsule endoscopy, Esophagogastroduodenoscopy |
Primary outcome
The accuracy of capsule endoscopy for detecting esophageal varices
Time frame: June 2006-February 2008
1 secondary outcome
Time to perform and interpret capsule endoscopy study
Time frame: June 2006-February 2008
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 1 Feb 2013.
- Background: PubMed 12016427Jensen DM. Endoscopic screening for varices in cirrhosis: findings, implications, and outcomes. Gastroenterology. 2002 May;122(6):1620-30. doi: 10.1053/gast.2002.33419.
- Background: PubMed 15825071Jutabha R, Jensen DM, Martin P, Savides T, Han SH, Gornbein J. Randomized study comparing banding and propranolol to prevent initial variceal hemorrhage in cirrhotics with high-risk esophageal varices. Gastroenterology. 2005 Apr;128(4):870-81. doi: 10.1053/j.gastro.2005.01.047.
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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?
An observational study of Esophageal Varices, run by University of California, Los Angeles 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 6 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: finished, as of the sponsor's last update on 1 Feb 2013. 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 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?
The accuracy of capsule endoscopy for detecting esophageal varices (time frame: June 2006-February 2008). 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 NCT01079416, 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 1 Feb 2013.