Assessing changes in oesophageal physiology and reflux in patients with gastro-oesophageal reflux disease (GORD) after a novel, minimally invasive endoscopic anti-reflux procedure – RAP (Resection and Plication).

Dr Calvin Park0 sites10 target enrollmentSeptember 30, 2024

Conditionsgastro-oesophageal reflux disease (GORD)Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Overview

Phase: 未知
Intervention: Not specified
Conditions: gastro-oesophageal reflux disease (GORD)
Sponsor: Dr Calvin Park
Enrollment: 10
Primary Endpoint: Change in Acid Exposure Time (AET) [pH/impedance study once baseline before RAP and once 3-6 months post-RAP. There also may be further follow ups post-RAP as required, up to 24 months. ];Change patients' reported reflux symptoms [GERD-HRQL questionnaire once baseline pre-RAP and once 3-6 months post-RAP. There also may be further follow ups post-RAP as required, up to 24 months. ]
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 30, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Dr Calvin Park

Eligibility Criteria

Inclusion Criteria

•The main inclusion criterion is that the patient has been deemed appropriate clinically and willing to undergo RAP procedure. The patient must be able to provide informed consent for the procedure and be of 18 years or older.Patients will have the following physiological and symptomatic characteristics on prior clinical assessments:•Patients with significant reflux as demonstrated by prolonged acid exposure time (AET) of 6% or more on a pH reflux study.•Patients with significant reflux symptoms (high symptom association probability, SAP) on a pH reflux study.•If patients demonstrated borderline AET of 4-6% - high reflux episodes (more than 80) or high SAP•Patients that are refractory to daily PPI therapy – AET 4% or more on a maximum tolerated acid lowering therapy.

Exclusion Criteria

•Patients who are not appropriate or eligible for RAP procedure•Prior anti-reflux procedures, including fundoplication and endoscopic plication or TIF•Prior gastric surgery, including weight reduction surgery•Presence of oesophageal motility disorder (Eg. Achalasia) as measured by manometry•Presence of a large hiatus hernia (greater than 2cm)•Significant mental health issue or cognitive impairment affecting ability to provide informed consent•Pregnant or breast feeding•Significant coagulopathy or those who cannot safely interrupt the course of anticoagulation for few days for the RAP procedure.

Outcomes

Primary Outcomes

Change in Acid Exposure Time (AET) [pH/impedance study once baseline before RAP and once 3-6 months post-RAP. There also may be further follow ups post-RAP as required, up to 24 months. ];Change patients' reported reflux symptoms [GERD-HRQL questionnaire once baseline pre-RAP and once 3-6 months post-RAP. There also may be further follow ups post-RAP as required, up to 24 months. ]