None listed
Conditions
Brief summary
Resection and Plication (RAP) is a new endoscopic procedure that has been shown to improve reflux symptoms. This study aims to compare oesophageal physiology and reflux-related oesophageal acidification as well as symptoms before and after RAP. This work will help to strengthen current understanding of the efficacy of this procedure. Patients must be clinically appropriate and willing to undergo the Resection and Plication endoscopic procedure. Baseline testing (pH studies, manometry and questionnaires) will occur before RAP and 3-6 months post-RAP, to measure change in patient symptoms and physiology.
Interventions
Intervention: Resection and Plication (RAP) Procedure. Provided by a trained Gastroenterologist at Sydney Gastroenterology and Liver, Sydney Adventist Hospital. The RAP procedure typically is performed under sedation using an endoscopic approach. Part of the gastric mucosa is resected and sutured to approximate the tissue to create a tighter valve between the stomach and oesophagus. Mucosa is resected using a special endoscopic needle and sutured using a endoscopic suturing device. This procedur
Intervention: Resection and Plication (RAP) Procedure. Provided by a trained Gastroenterologist at Sydney Gastroenterology and Liver, Sydney Adventist Hospital. The RAP procedure typically is performed under sedation using an endoscopic approach. Part of the gastric mucosa is resected and sutured to approximate the tissue to create a tighter valve between the stomach and oesophagus. Mucosa is resected using a special endoscopic needle and sutured using a endoscopic suturing device. This procedure may take anywhere from 45 minutes to 120 minutes depending on the patient’s anatomy. The patient will be admitted to the Sydney Adventist Hospital overnight for monitoring but in some limited cases you the patient be able to be discharged home on the same day. Patients will be followed up be phone call a few weeks later to check on progress including any potential side effects. There is no monitoring of adherence as it is a one-off procedure. However, there will be follow up and assessment of efficacy as described in the 'Outcomes' sections. Population: Patients with gastro-oesophageal reflux disease that have been referred to the Sydney Gastroenterology and Liver Group and deemed suitable for the Resection and Plication procedure. Mode: * The RAP procedure will be delivered once, face-to-face * Follow-up will be provided via face-to-face, internet and/or telephone communication * Follow-up will occur for up to 24 months as required.
Sponsors
Dr Calvin Park
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed