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Sponsored by: |
University of Chicago |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00455078 |
Recent data has suggested that GER (gastric reflux) may worsen after lung transplantation and potentially increase the risk of chronic rejection (CR) after lung transplantation. The purpose of this study is to look at how often GER occurs in the lung transplant population and examine how GER may change the immune system and cause CR. In this way, we would be able to better identify patients that may benefit from anti-reflux procedures.
Condition | Intervention |
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Gastroesophageal Reflux |
Procedure: esophagogastroduodenoscopy Other: Standard GER questionnaire (RDQ) Procedure: Scintigraphic evaluation of solid gastric emptying Procedure: Twenty-four hour ambulatory pH testing Procedure: Esophageal manometry testing |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | The Role of Reflux in Innate Immunity Activation After Lung Transplantation. |
Estimated Enrollment: | 20 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2008 |
Part of standard pre-transplant work up includes a gastrointestinal (GI) work-up to check for GER. The following procedures will be done pre-transplant.
These procedures will be done again at 3 to 6 months post transplant. The results of the EGD, scintigraphic evaluation, answers of RDQ, pH testing, esophageal manometry and bronchoscopy will be collected as well as spirometries and any episodes of rejection.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects who have undergone pretransplant evaluation and are on the waiting list or subjects transplanted < 18mos.
Inclusion Criteria:
Exclusion Criteria:
Contact: Lourdes Norwick, BSN, RN | 773-834-8076 | lnorwick@medicine.bsd.uchicago.edu |
United States, Illinois | |
The University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Lourdes Norwick, BSN, RN 773-834-8076 lnorwick@medicine.bsd.uchicago.edu | |
Principal Investigator: Sangeeta M. Bhorade, MD | |
Sub-Investigator: Gautham Reddy, MD | |
The University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Lourdes Norwick, BSN, RN 773-834-8076 lnorwick@medicine.bsd.uchicago.edu | |
Principal Investigator: Sangeeta M Bhorade, MD |
Principal Investigator: | Sangeeta M. Bhorade, MD | University of Chicago |
Responsible Party: | University of Chicago Hospitals ( Sangeeta Bhorade ) |
Study ID Numbers: | 15272A |
Study First Received: | April 2, 2007 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00455078 History of Changes |
Health Authority: | United States: Institutional Review Board |
Gastric reflux Lung transplant chronic rejection Gastric reflux in lung transplant as it relates to chronic rejection |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases Esophageal Diseases Gastroesophageal Reflux |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases |
Gastrointestinal Diseases Esophageal Diseases Gastroesophageal Reflux |