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
  Purpose

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
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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Reflux in Innate Immunity Activation After Lung Transplantation.

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Enrollment: 20
Study Start Date: June 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455078

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Sangeeta M. Bhorade, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00455078     History of Changes
Other Study ID Numbers: 15272A
Study First Received: April 2, 2007
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Gastric reflux
Lung transplant
chronic rejection
Gastric reflux in lung transplant as it relates to chronic rejection

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 26, 2014