RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol

• Register: ClinicalTrials.gov
• Last refreshed on: 4 March 2013
• Main ID: NCT01406210
• Date of registration: 28/06/2011
• Primary sponsor: Duke University
• Public title: RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol RESULT
• Scientific title: Prospective and Retrospective Study to Develop a Multi-center Randomized Study, to Determine if Prevention of GERD Related Aspiration by Surgical Fundoplication Improves Lung Allograft Function
• Date of first enrolment: September 2011
• Target sample size: 925
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01406210
• Study type: Observational
• Study design: Observational Model: Case-Only

Countries of recruitment

Canada, United States

Contacts

• Name: Robert D. Davis, MD

• Name: Robert D. Davis, MD
• Affiliation: Duke University

• Name: Scott Palmer, MD
• Affiliation: Duke University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or non-pregnant female subject

2. 16 years of age

3. Recipient of a double-lung transplant

4. 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.

Exclusion Criteria:

1. Recipient of a single-lung transplant

2. Recipient of a re-do lung transplant

3. Recipient of a double-lung/heart or double-lung/ other organ transplant

4. 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

5. No Spirometry data is available for the subject

6. Subject who is participating in any other interventional clinical study

7. Unable to provide written informed consent or participate in long-term follow-up



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Gastroesophageal Reflux Disease (GERD)

Reflux

Primary Outcome(s)

Acute Rejection [Time Frame: 1 year]

BAL aspiration markers [Time Frame: 1 year]

BOS [Time Frame: 1 year]

Death [Time Frame: 1 year]

FEV-1 [Time Frame: 1 year]

Secondary ID(s)

1R34HL105422-01

Pro00025618

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)