NCT00512512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 1, 2010

Status Verified

July 1, 2009

Enrollment Period

7 months

First QC Date

August 6, 2007

Last Update Submit

June 30, 2010

Conditions

SteatohepatitisMorbid Obesity

Keywords

transoraltransluminalendoscopiclaparoscopicliverbiopsy

Interventions

Transoral Endoscopic Liver BiopsyPROCEDURE

Liver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Morbid Obese patients who are already approved for gastric bypass surgery.

You may qualify if:

  • 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).

You may not qualify if:

  • Inability to give informed consent
  • Women who are pregnant or in whom pregnancy status cannot be confirmed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • 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.

    PMID: 18308313RESULT

MeSH Terms

Conditions

Fatty LiverObesity, Morbid

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael A Schweitzer, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 7, 2007

Study Start

June 1, 2007

Primary Completion

January 1, 2008

Study Completion

June 1, 2009

Last Updated

July 1, 2010

Record last verified: 2009-07

Locations

US(1)