GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection

Gastroesophageal Reflux Clinical Trial

— LTXGERD  

Official title:

The Role of Reflux in Innate Immunity Activation After Lung Transplantation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455078
• Other study ID #: 15272A
• Status: Completed
• Phase: N/A
• First received: April 2, 2007
• Last updated: September 4, 2013
• Start date: June 2007
• Est. completion date: January 2010

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

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.
• Twenty-four hour ambulatory pH testing
Twenty-four hour ambulatory pH testing will be done pretransplant then again before 18mos post transplant.
• Esophageal manometry testing
Esophageal manometry testing will be done pretransplant then again before 18mos post transplant.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States,