RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol

Completed

Conditions studied: Reflux, Gastroesophageal Reflux Disease (GERD)

In brief

The purpose of the prospective study is to collect information surrounding lung transplant in order to develop a randomized study to determine if prevention of gastroesophageal reflux disease (GERD) related aspiration (stomach acid coming up from the stomach into the esophagus) by surgical fundoplication improves lung rejection. Lung transplantation has evolved into an effective treatment for patients with end-stage lung disease; however, a significant limitation to long-term survival is patients develop a condition of scarring known as chronic lung rejection, which can cause lung function to deteriorate, thereby reducing a patient's chances for survival. Preliminary research has shown a correlation between the presence of gastroesophageal reflux disease (GERD) and impaired early lung rejection as assessed by a breathing test, FEV1 (the amount of forced expired air volume in 1 second). The Investigator is interested in learning more about this condition and the potential for aspiration (inhaling fluid) injury. The primary goal of this preliminary study will be to identify aspiration markers that are correlated with adverse clinical outcomes (increased early rejection, decreased FEV1) that may be used as inclusion criteria for the future randomized trial. The purpose of the retrospective study is to collect information surrounding lung transplant in order to develop a randomized study to determine if prevention of gastroesophageal reflux disease (GERD) related aspiration (stomach acid coming up from the stomach into the esophagus) by surgical fundoplication improves lung rejection. The goal of this retrospective data collection is to review the following: 1. subject outcome event rates for subjects with and without gastroesophageal reflux disease (GERD) for survival, Bronchiolitis Obliterans Syndrome (BOS), acute rejection and Forced Expiratory Volume in the first second (FEV-1), 2. the estimated treatment effect of fundoplication on the above event rates, 3. a threshold effect for Bronchiolitis Obliterans Syndrome (BOS) and/or death are more likely to occur at higher or more proximal acid or non-acid contact times. This data will be collected in order to better design and coordinate a multicenter prospective study.

Key facts

Study ID: NCT01406210
Run by: Duke University
People needed: 647
Starts: 2011-09-01
Expected to finish: 2013-08-01
Last updated by the study team: 2014-09-12

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or non-pregnant female subject
16 years of age
Recipient of a double-lung transplant
Previously have a 24-hour esophageal pH and/or impedance probe study within 12 months prior to transplant and/or within 12 months following transplantation. If the subject expired prior to 12 months from transplant date, they must have had a 24-hour esophageal pH and/or impedance probe study to be eligible in the study.

You may not qualify if…

Recipient of a single-lung transplant
Recipient of a re-do lung transplant
Recipient of a double-lung/heart or double-lung/ other organ transplant
Do not have a 24-hour esophageal pH and/or impedance probe study within 12 months pre-transplant or within 12 months following transplantation. The subject expired less than 12 months post transplant without having a 24-hour esophageal pH and/or impedance probe study
No Spirometry data is available for the subject
Subject who is participating in any other interventional clinical study
Unable to provide written informed consent or participate in long-term follow-up

Where it is running

Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
Duke University Medical Center — Durham, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
University of Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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