GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Observational

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.
    

Intervention name(s): esophagogastroduodenoscopy; Standard GER questionnaire (RDQ); Scintigraphic evaluation of solid gastric emptying; Twenty-four hour ambulatory pH testing; Esophageal manometry testing
Intervention type(s): Procedure; Other; Procedure; Procedure; Procedure
Intervention description(s): EGD will be done pretransplant then again before 18mos post transplant.; RDQ questionnaire will be done pretransplant then again before 18mos post transplant.; Scintigraphic evaluation of solid gastric emptying will be done pretransplant then again before 18mos post transplant.; Twenty-four hour ambulatory pH testing will be done pretransplant then again before 18mos post transplant.; Esophageal manometry testing will be done pretransplant then again before 18mos post transplant.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who have undergone pretransplant evaluation and are on the waiting list or
        subjects transplanted < 18mos.
      
Keywords: Gastric reflux; Lung transplant; chronic rejection; Gastric reflux in lung transplant as it relates to chronic rejection