How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Interventional procedure overview of endoluminal gastroplication for gastro-oesophageal reflux disease

    Closed for comments This consultation ended on at   Request commenting lead permission

    2In the systematic review and meta-analysis of 1,475 people, the mean proportion of people who reported stopping PPIs after the procedure (follow up range 1.5 to 59 months) was 89% (95% CI 82% to 95%; 28 studies, n=1,407; p<0.001, I=93.6%; McCarty 2018).

    In the case series of 50 people, the proportion of people who halved PPI doses or stopped PPI altogether was 78% (39/50) at 2-year follow up, 76% (38/50) at 3 years, 60% (25/42) at 5 years, 65% (20/31) at 7 years and 73% (11/15) at 10 years in ITT analysis (Testoni 2019).

    In a crossover RCT of 63 people, the percentage of people on daily PPI therapy decreased from 100% at baseline to 17% (n=60) at 1 year, 27% (n=52) at 3 years and 34% (95% CI 22 to 49%) at 5 years. At 5-year follow up, 46% (95% CI 32 to 60%) of people reported completely stopping PPI therapy (Trad 2018).

    In the crossover RCT of 63 people, the median GORD-HRQL score at baseline in those completing 3-year follow up was 24 (95% CI 9.7 to 30.6) and decreased to 2.5 (95% CI 0.47 to 8.7, p=0.007) after 3 years. The proportion of people who had at least a 50% reduction in symptom score according to GORD-HRQL in ITT analysis was 67% (31/46) at 6 months, 65% (30/46) at 1 year, 64% (25/39) at 2 years and 60% (21/35) at 3 years (Trad 2018).

    In the case series of 46 people, the proportion of people who stopped or at least halved PPI dose was 80% (37/46) at 6 months, 83% (38/46) at 1 year, 80% (31/39) at 2 years and 77% (27/35) at 3 years (Testoni 2022).

    In the RCT of 70 people, the percentage of people off PPI at 12-month follow up was 63% (22/35) in the EFTP versus 11% (4/35) in the sham group (p<0.001; Kalapala 2022).

    In the case series of 57 people, the percentage of people achieving PPI cessation was 47% after a median 12-month follow up (n=36) and 27% after a median 97-month follow up (n=23; Chimikungara 2018).

    Oesophageal pH measurement and acid exposure

    In the systematic review and meta-analysis of 1,475 people, the SMD between oesophageal acid exposure time before and after all procedures was 3.43 (95% CI 2.98 to 3.88; 15 studies, n=722; p<0.001; I2 = 86%) with a follow up range from 1.5 to 36 months.

    In the same study, the SMD between the mean number of reflux episodes in a 24-hour period before and after all procedures (follow up range 6 to 36 months) was 51.57 (95% CI 47.96 to 55.18; 13 studies, n=695; p<0.001; I2 = 85%), and the SMD between DeMeester scores before and after all procedures ((follow up range 6 to 36 months) was 10.22 (95% CI 8.31 to 12.12; 11 studies, n=647; p<0.001; I2 = 65%; McCarty 2018).

    In the crossover RCT of 63 people, it was reported that 40% (16/40) achieved pH normalisation (defined as <5.3% of time with pH<4) at 3-year follow up (Trad 2018).

    In the case series of 46 people, the number of acid refluxes decreased from a median baseline of 37 (IQR 24.5 to 54.2) to 24 (IQR 12.3 to 41.2) at 6-month follow up (p=0.0002) and 27.5 (IQR 13.4 to 46.6) at 1-year follow up (p=0.15). In the same study, the median percentage time with oesophageal pH < 4 decreased from 5.8% (IQR 1.5% to 8.3%) at baseline to 3.8% (1.3% to 5.1%) at 6-month follow up (p=0.006) and 4.2% (IQR 2.9% to 5%) at 1-year follow up (p=0.16; Testoni 2022).

    In the RCT of 70 people, the median number of acid reflux episodes decreased from 51 (IQR 33 to 73) at baseline to 34 (IQR 16 to 63) at 3-month follow up (p=0.005); there was a further decrease to 32 (IQR 18 to 74) at 12-month follow up but this was not statistically significant (p=0.316; Kalapala 2022).

    Need for reintervention

    In the evidence synthesis of 580 people done as part of a HTA, 18 surgical reinterventions were reported across 2 RCTs; 14 in the intervention groups (11 endoscopic and 3 laparoscopic) and 4 in the control groups (all laparoscopic). In an observational study of 100 people also included in the HTA, 7 laparoscopic interventions and 1 endoscopic intervention was reported (Grössmann 2021).

    In the case series of 57 people, 21% (12/57) of people had subsequent laparoscopic surgery after recurrent GORD at a median interval of 24 (IQR 10 to 36) months after TIF (Chimikungara 2018).