SteatohepatitisNCT00512512
Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass
An observational study of Steatohepatitis and Morbid Obesity, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to evaluate the ability to obtain a liver sample using upper endoscopy rather than through a laparoscopic procedure. The investigators hypothesize that the endoscopic transoral route is as effective as the laparoscopic route. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Steatohepatitis, Morbid Obesity
- What is being tested?
- Transoral Endoscopic Liver Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Morbid Obese patients who are already approved for gastric bypass surgery.
Who may be able to join
- Any patient who meets criteria to undergo laparoscopic Roux-en Y Gastric Bypass (BMI>40 or BMI>35 with multiple medical co morbidities).
- Age greater than 18 years.
- Ability to complete all necessary components of study (gastric bypass surgery standard qualifications).
Who cannot join
- Inability to give informed consent
- Women who are pregnant or in whom pregnancy status cannot be confirmed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
This research is being done to evaluate the ability to obtain a liver sample using upper endoscopy rather than through a laparoscopic procedure. The investigators hypothesize that the endoscopic transoral route is as effective as the laparoscopic route.
- Conditions
- Steatohepatitis, Morbid Obesity
- Being tested
- Transoral Endoscopic Liver Biopsy
- Keywords
- transoral, transluminal, endoscopic, laparoscopic, liver, biopsy
- Medical subject headings
- Fatty Liver, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral Endoscopic Liver BiopsyProcedure or surgery
Liver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionJan 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SteatohepatitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Investigators
- Michael A Schweitzer, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512512
- Sponsor's protocol ID
- NA_00007226
- Status last verified
- Jul 2009
- First submitted
- 6 Aug 2007
- Last updated
- 1 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Steele K, Schweitzer MA, Lyn-Sue J, Kantsevoy SV. Flexible transgastric peritoneoscopy and liver biopsy: a feasibility study in human beings (with videos). Gastrointest Endosc. 2008 Jul;68(1):61-6. doi: 10.1016/j.gie.2007.09.040. Epub 2008 Mar 4.
PubMed 18308313
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass
- ClinicalTrials.gov ID
- NCT00512512
- Acronym / sponsor ID
- NA_00007226
- Conditions
- Steatohepatitis, Morbid Obesity
- Keywords
- transoral, transluminal, endoscopic, laparoscopic, liver, biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Aug 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.
This research is being done to evaluate the ability to obtain a liver sample using upper endoscopy rather than through a laparoscopic procedure. The investigators hypothesize that the endoscopic transoral route is as effective as the laparoscopic route.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Morbid Obese patients who are already approved for gastric bypass surgery.
Key inclusion criteria (3 listed)
- Any patient who meets criteria to undergo laparoscopic Roux-en Y Gastric Bypass (BMI>40 or BMI>35 with multiple medical co morbidities).
- Age greater than 18 years.
- Ability to complete all necessary components of study (gastric bypass surgery standard qualifications).
Key exclusion criteria (2 listed)
- Inability to give informed consent
- Women who are pregnant or in whom pregnancy status cannot be confirmed.
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 |
|---|---|---|
| Transoral Endoscopic Liver BiopsyLiver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 Jul 2010.
- Results publication: PubMed 18308313Steele K, Schweitzer MA, Lyn-Sue J, Kantsevoy SV. Flexible transgastric peritoneoscopy and liver biopsy: a feasibility study in human beings (with videos). Gastrointest Endosc. 2008 Jul;68(1):61-6. doi: 10.1016/j.gie.2007.09.040. Epub 2008 Mar 4.
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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.
Michael A Schweitzer, M.D. 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?
An observational study of Steatohepatitis and Morbid Obesity, 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 2 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 Jul 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00512512, which also lists 1 linked publication.
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 Jul 2010.