None listed
Conditions
Brief summary
Gastro-oesophageal reflux disease (GORD) is common, affecting up to 30% of the population, with an increasing prevalence including younger patients.Symptoms have been shown to have significant impact on quality of life and productivity with considerable economic burden. Although medical treatment such as proton pump inhibitors (PPI) may be successful in treating up to 80% of patients with erosive disease, compliance, side-effects and patient preference may limit efficacy. In addition, non-erosive disease and regurgitation is less successfully treated with PPI. In these patients, anti-reflux surgery with fundoplication has been the traditional treatment, shown to be more effective than medical management with respect to patient-relevant outcomes, although some uncertainty remains with respect to longer term outcomes. More recently, simple endoscopic techniques have been developed as an alternative to tighten the lower oesophageal junction. Ablation with argon plasma coagulation (ARMA) to create ulceration, fibrosis and subsequent constriction have been described. A recent meta-analysis of 15 studies using these techniques demonstrate them to be safe and efficacious for PPI refractory reflux. Few studies exist comparing endoscopic to surgical techniques. A retrospective review comparing endoscopic to laparoscopic Nissen fundoplication suggested better perioperative outcomes with regard to operation time, blood loss, hospital stay and pain, with comparable reflux quality of life outcomes to 2 years. No prospective randomised trials exist.
Interventions
ARMA: (Anti-reflux mucosal ablation).
This will usually be performed under local sedation (where you will still be breathing on your own). Here the junction is lasered, which as it heals and scars, tightens the junction. This is called anti-reflux mucosal ablation (AMRA).
i.e. Ablation of gastro-oesophageal junction with argon plasma coagulation to create ulceration, fibrosis and subsequent constriction and tightening of the junction to prevent reflux.
Performed by Gastroenterologist. Proced
ARMA: (Anti-reflux mucosal ablation). This will usually be performed under local sedation (where you will still be breathing on your own). Here the junction is lasered, which as it heals and scars, tightens the junction. This is called anti-reflux mucosal ablation (AMRA). i.e. Ablation of gastro-oesophageal junction with argon plasma coagulation to create ulceration, fibrosis and subsequent constriction and tightening of the junction to prevent reflux. Performed by Gastroenterologist. Procedure recorded on clinical record. Estimated time: 30 minutes. Equipment: APC (Argon plasma coagulation) generator & straight fire probe EMR (endoscopic mucosal resection) solution – saline with 0.5% methylene blue Clear endoscope cap Specify endoscope with adequate flex (ie older scope) IV (intravenous) omeprazole and antiemetic as part of sedation ERBE Vio-200D Effect 3 100W (Mexican), VIO300D Effect 2 50W (Japanese) Procedure • Evaluate & clean GOJ (Gastro-oesophageal junction) & Hill Grade • Mark borders of ablation; Effect 2 soft coagulation o Markers around inner border 1cm from GOJ, o Markers either side of 1cm greater curve untouched segment (<90o) o Markers on outer border 1-2cm width, horse-shoe shape • Lift cushion with EMR solution • Sequential Ablation with ERBE • Scrape/Clear tissue with cap • Complete ablation if necessary
Sponsors
Te Whatu Ora - Waitemata (North Shore Hospital)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Symptomatic gastro-oesophageal reflux, despite 2 months twice daily of PPI (proton pump inhibitor) use, and attempts to optimise lifestyle measures contributing to reflux events. Confirmation of pathological reflux via 24-hr Oesophageal pH testing; either • Acid Exposure Time >6% • DeMeester Score >14.7 • Positive SAP (symptom association probability) (95%) with SI (Symptom index) >70% Or: • Los Angeles (LA) Grade C-D oesophagitis High resolution oesophageal manometry performed in all patients to confirm the absence of major oesophageal motility disorders. Consenting to participate in trial: willing to undergo either ARMA or surgical fundoplication
Exclusion criteria
Hiatus Hernia; Hill Grade IV or sliding hiatus hernia >2cm Contra-indications to surgical fundoplication - Previous major abdominal surgery precluding laparoscopy - Previous gastric surgery Major motility disorder on HR (high resolution) manometry assessment (as defined by Kahrilas et al) - Minor motility disorder with functional impact (abnormal Ba swallow or solid food challenge) Pregnancy
Outcome results
None listed