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NCT01406210 · ClinicalTrials.gov registry record
RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 647
- Enrollment target
NCT01406210: Completed study, sponsored by Duke University.
NCT01406210 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 647 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01406210 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 647 participants
- Enrollment target
Study Summary
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 t
Primary Outcome
For the prospective study analysis, we will be assessing the relationship of gastroesophageal reflux and aspiration post lung transplantation with the occurrence of lung allograft dysfunction by reviewing BAL samples prospectively collected in approximately 125 subjects. These BAL samples will be assayed for bile acids; pepsin, pepsinogen I and II; trypsin; gastrin, and LPS content. The correlation of the aspiration biomarkers to acute rejection, BOS, death and FEV-1 at one year will be assessed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 647 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-08 |
What the finished NCT01406210 record still lists
NCT01406210 is an observational study that tracks outcomes without assigning an intervention. The registered 647 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01406210 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01406210 about?
NCT01406210 is a clinical study titled "RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol". 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 fundoplic...
What is the current status of trial NCT01406210?
This trial is currently completed. The enrollment target is 647 participants. The study started on 2011-09. Estimated completion is 2013-08.
Who is sponsoring clinical trial NCT01406210?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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