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GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection

NCT ID: NCT00455078

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Gastroesophageal Reflux

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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esophagogastroduodenoscopy

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

Intervention Type PROCEDURE

Standard GER questionnaire (RDQ)

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

Intervention Type OTHER

Scintigraphic evaluation of solid gastric emptying

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

Intervention Type PROCEDURE

Twenty-four hour ambulatory pH testing

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

Intervention Type PROCEDURE

Esophageal manometry testing

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sangeeta M. Bhorade, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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15272A

Identifier Type: -

Identifier Source: org_study_id