Efficacy and Safety of STRETTA Procedure for GORD in Children
Research type
Research Study
Full title
A Prospective Pilot Study for treatment of Gastro-Oesophageal Reflux Disease in Children: Efficacy and Safety of STRETTA Procedure (PROGRESS study)\n
IRAS ID
259396
Contact name
Shishu Sharma
Contact email
Sponsor organisation
Sheffield Children's Hospital NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Gastro-oesophageal reflux (GOR) is a normal physiological phenomenon that is described as passage of gastric contents into the oesophagus. However, when this physiological phenomenon becomes frequent or severe enough to cause marked distress or complications, requiring medical treatment, then it is referred to as gastro-oesophageal reflux disease (GORD). \nGORD tends to resolve by 12 months of age in about 90% of those affected, however some children continue to need medical treatment or develop complications. The possible complications of GORD are refusal to feed (feed aversion), distressed behaviour, frequent gagging, choking, chronic cough, recurrent aspiration pneumonia, faltering growth, dental erosions, chronic otitis media, hoarseness of voice (laryngo-pharyngeal reflux), reflux oesophagitis and Barrett’s oesophagus (premalignant condition). The more severe the problem in infancy the more likely that this will become a significant health issue in later childhood.\nThe most frequently used medication to treat GORD are proton pump inhibitors (PPIs) however recently there has been an increase in the number of studies highlighting the adverse effects related to long term use of PPIs: Vitamin B12 deficiency1; bone fractures2; low magnesium3,4; enteric infection5; pneumoni6,7,8,9 and increased cardiovascular risk10.\nThere is limited data paediatric data regarding GORD disease burden having socio-economic impact. The most of the data is extrapolated from adult population. As per a US study GORD was most common diagnosis for patients presenting with gastrointestinal complaint in 2012, accounting for 9 million outpatient visits11. Another study suggested that the treatment cost of GORD in 2004 was around $12billiion, with Proton Pump Inhibitors accounting for 2/3 of the treatment cost12. We also know that the use of PPIs for the treatment of GORD is ever increasing13.\nThe total cost of fundoplication can vary from £4519 to £11096 depending on the age of the child and presence of comorbidities. The cost is higher if they require HDU bed i.e. £1148 per day. The rate for revision of fundoplication similarly can vary from £3260 to £8006. The above figures give an indication around the high cost incurred for the treatment of GORD.\nThe children who are not amenable to medical treatment or develop severe complications are the candidates for surgical management. Surgical management is generally a fundoplication - wrapping the upper part of stomach around the lower part of oesophagus. The classical operation, or open Nissen’s fundoplication, fails to relieve symptoms in ~20% and the operative mortality is about 0.9-3.0%. The post-operative complication rate related to this surgery can vary from 26% to 59%. The common complications include recurrent reflux, dysphagia, gas-bloat syndrome, dumping syndrome and retching. Similarly the post-operative complications of laparoscopic fundoplication are; recurrence or persistence of symptoms in 6.6-19%, need to repeat the procedure in 2-8% of cases, post-procedure reflux-related mortality in 0.3%, dysphagia, gas-bloat syndrome and retching. \nEndoscopy-delivered radiofrequency ablation therapy (Stretta) for the treatment of GORD has evolved over the last few years as a promising alternative. NICE has recently published its recommendations for the use of this modality in the treatment of reflux disease in adults.\nThe aim of this study is to evaluate the safety and efficacy of the Stretta procedure in the paediatric population.\n\n
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0196
Date of REC Opinion
6 Aug 2019
REC opinion
Further Information Favourable Opinion