Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection (LTXGERD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00455078
First received: April 2, 2007
Last updated: September 4, 2013
Last verified: September 2013

April 2, 2007
September 4, 2013
June 2007
January 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00455078 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection
The Role of Reflux in Innate Immunity Activation After Lung Transplantation.

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.

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.

  1. Standard GER questionnaire (RDQ): This is a 12 item questionnaire. This questionnaire will ask questions about any reflux symptoms present.
  2. Esophagogastroduodenoscopy (EGD): This test will determine evidence of esophageal reflux and presence of a hiatal hernia.
  3. Scintigraphic evaluation of solid gastric emptying: This measures the speed with which food empties from the stomach and enters the small intestine.
  4. Twenty-four hour ambulatory pH testing: The ambulatory 24-hour pH monitoring test will monitor the acid in the esophagus during a 24-hour period.
  5. Esophageal manometry testing: This procedure is done to evaluate the cause of reflux of stomach acid and contents back into the esophagus, and to determine the cause of problems with swallowing food.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects who have undergone pretransplant evaluation and are on the waiting list or subjects transplanted < 18mos.

Gastroesophageal Reflux
  • Procedure: esophagogastroduodenoscopy
    EGD will be done pretransplant then again before 18mos post transplant.
  • Other: Standard GER questionnaire (RDQ)
    RDQ questionnaire will be done pretransplant then again before 18mos post transplant.
  • Procedure: Scintigraphic evaluation of solid gastric emptying
    Scintigraphic evaluation of solid gastric emptying will be done pretransplant then again before 18mos post transplant.
  • Procedure: Twenty-four hour ambulatory pH testing
    Twenty-four hour ambulatory pH testing will be done pretransplant then again before 18mos post transplant.
  • Procedure: Esophageal manometry testing
    Esophageal manometry testing will be done pretransplant then again before 18mos post transplant.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are undergoing pre-lung transplant evaluations at the University of Chicago Hospital
  • Patients who are capable of becoming pregnant must have a negative pregnancy test prior to consent.
  • All patients must be able to give written informed consent.

Exclusion Criteria:

  • Pre-transplant patients in whom study procedures are contraindicated or patients who are unable to complete all the study procedures.
  • Patients who are unable to give consent
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00455078
15272A
No
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Sangeeta M. Bhorade, MD University of Chicago
University of Chicago
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP