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GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00455078
Acronym
LTXGERD
Enrollment
20
Registered
2007-04-03
Start date
2007-06-30
Completion date
2010-01-31
Last updated
2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

Gastric reflux, Lung transplant, chronic rejection, Gastric reflux in lung transplant as it relates to chronic rejection

Brief 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.

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.

Interventions

PROCEDUREesophagogastroduodenoscopy

EGD will be done pretransplant then again before 18mos post transplant.

OTHERStandard GER questionnaire (RDQ)

RDQ questionnaire will be done pretransplant then again before 18mos post transplant.

PROCEDUREScintigraphic evaluation of solid gastric emptying

Scintigraphic evaluation of solid gastric emptying will be done pretransplant then again before 18mos post transplant.

PROCEDURETwenty-four hour ambulatory pH testing

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

PROCEDUREEsophageal manometry testing

Esophageal manometry testing will be done pretransplant then again before 18mos post transplant.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026