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OpenTrials
Completed

NCT Number: NCT00455078

GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

  • Standard GER questionnaire (RDQ): This is a 12 item questionnaire. This questionnaire will ask questions about any reflux symptoms present.
  • Esophagogastroduodenoscopy (EGD): This test will determine evidence of esophageal reflux and presence of a hiatal hernia.
  • Scintigraphic evaluation of solid gastric emptying: This measures the speed with which food empties from the stomach and enters the small intestine.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophagogastroduodenoscopy

Procedure

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

Standard GER questionnaire (RDQ)

Other

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

Scintigraphic evaluation of solid gastric emptying

Procedure

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

Twenty-four hour ambulatory pH testing

Procedure

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

Esophageal manometry testing

Procedure

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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Acronym: LTXGERD

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 3, 2007
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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