Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass
This study has been completed.
Sponsor:
Johns Hopkins University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00512512
First received: August 6, 2007
Last updated: June 30, 2010
Last verified: July 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 6, 2007 | ||||
| Last Updated Date | June 30, 2010 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00512512 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass | ||||
| Official Title ICMJE | Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass | ||||
| Brief 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Morbid Obese patients who are already approved for gastric bypass surgery. |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Procedure: Transoral Endoscopic Liver Biopsy
Liver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass |
||||
| Study Group/Cohort (s) | Not Provided | ||||
| 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. Epub 2008 Mar 4. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 4 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00512512 | ||||
| Other Study ID Numbers ICMJE | NA_00007226 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Michael Schweitzer, M.D., Johns Hopkins | ||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Johns Hopkins University | ||||
| Verification Date | July 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||