2 The procedure
2.1.1 GORD is caused by failure of the sphincter mechanism in the lower oesophagus. Symptoms include heartburn, chest pain, nausea and respiratory difficulties. Complications include development of Barrett's oesophagus or oesophageal stricture.
2.1.2 Lifestyle modification and gastric acidity-lowering medication can help improve symptoms. For patients with symptoms that do not respond to conservative therapy, anti-reflux surgery (usually laparoscopic fundoplication) may be required.
2.2.1 Endoluminal gastroplication for GORD is an endoscopic procedure that aims to avoid the need for surgical fundoplication.
2.2.2 With the patient under sedation or general anaesthesia, the procedure is carried out using a standard endoscope with an oesophageal overtube and an endoscopic suturing or fastening device. Multiple plications, or pleats, are made below the gastro-oesophageal junction with the aim of decreasing the reflux of stomach acid into the oesophagus.
2.2.3 A range of different devices are available for this procedure.
Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/guidance/IP/269/overview
2.3.1 An RCT of 60 patients comparing endoluminal gastroplication, sham procedure and no treatment reported improvement in mean heartburn score from baseline to 3-month follow-up of 50%, 6% and 18% respectively (gastroplication vs sham p = 0.003; sham vs no treatment p = not significant).
2.3.2 An RCT of 159 patients comparing endoluminal gastroplication with sham treatment reported improvement in GORD health-related quality of life score in 56% and 19% of patients respectively at 3-month follow-up (p < 0.001) (absolute figures not stated).
2.3.3 The RCT of 159 patients comparing endoluminal gastroplication with sham treatment reported a change in mean percentage of time exposed to acid reflux (defined as pH < 4) from baseline to 3-month follow-up of 10% to 7%, and from 9% to 10% respectively (p = 0.01 for between-group comparisons).
2.3.4 A non-randomised controlled study of 126 patients treated by endoluminal gastroplication or radiofrequency ablation reported a decrease from baseline in mean percentage of time exposed to acid reflux (defined as pH < 4) of 10% to 6% (p = 0.05) and 11% to 9% (p > 0.9) respectively (significance between groups not stated; mean follow-up 6-months).
2.3.5 The RCT of 60 patients comparing endoluminal gastroplication, sham treatment and no treatment reported a decrease of 50% or more in proton pump inhibitor medication requirement in 65% (13/20), 25% (5/20) and 0% (0/17) of patients respectively at 3-month follow-up (gastroplication vs sham p = 0.011; sham vs no treatment p = 0.05).
2.3.6 The Specialist Advisers considered a key efficacy outcome to be control of acid reflux without further surgery.
2.4.1 Intraoperative perforation of the oesophagus in 2% (2/86) of patients was reported in a case series of 86; both were treated by surgical repair, with no clinical sequelae.
2.4.2 Bilateral pneumothorax following withdrawal of the endoscopic device was described in a case report. The patient was treated by temporary chest tube insertion and was discharged after 2 days. Intraoperative bronchospasm requiring intubation was reported in 1 patient in a case series of 85 patients.
2.4.3 Post-procedural epigastric pain was reported in 12% (9/78) of patients in the endoluminal gastroplication group and in 4% (3/81) of patients in the sham group in the RCT of 159 patients (p = 0.076).
2.4.4 The RCT of 159 patients comparing endoluminal gastroplication with sham treatment reported vomiting (5% [4/78] and 4% [3/81] respectively), nausea (8% [6/78] and 1% [1/81]), and dysphagia (3% [2/78] and 2% [2/81]) after the procedure (follow-up not stated).
2.4.5 The Specialist Advisers considered theoretical adverse effects to include stenosis of oesophageal junction, early failure to control reflux, injury to surrounding tissues and organs, and foreign body sensation.