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Clinical feasibility of a new antireflux ablation therapy on gastroesophageal reflux disease (with video)

Published:April 25, 2020DOI:https://doi.org/10.1016/j.gie.2020.04.046

      Backgrounds and Aims

      New mucosal resective and ablative endoscopic procedures based on gastric cardiac remodeling to prevent reflux have appeared. We aimed to evaluate the feasibility of a new ablative technique named antireflux ablation therapy (ARAT) for control of GERD in patients without hiatal hernia.

      Methods

      Patients with proton pump inhibitor (PPI)-refractory GERD without hiatal hernia underwent ARAT between January 2016 and October 2019. Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL), upper endoscopy, 24-hour pH monitoring, and PPI use were documented at 3, 6, 12, 24, and 36 months after ARAT.

      Results

      One hundred eight patients were included (61 men [56.5%]; median age, 36.5 years; range, 18-78 years). ARAT was performed on all patients. At the 36-month evaluation, 84 patients had completed the protocol. Median ARAT time was 35.5 minutes (range, 22-51 minutes), and median circumference ablation was 300° (range, 270°-320°). No major adverse events occurred, and 14 of 108 patients (12.9%) presented with stenosis that was responsive to balloon dilation (<5 sessions). At the 3-month evaluation, the acid exposure time (AET), DeMeester score, and GERD-HRQL score had decreased from 18.8% to 2.8% (P = .001), 42.5 to 9.1 (P = .001), and 36.5 to 10 (P = .02), respectively, and these values were maintained up to 36 months. Success (AET <4%) was achieved in 89% and 72.2% at 3 and 36 months, respectively. Related factors at 36 months were as follows: pre-ARAT Hill type II (odds ratio [OR], 3.212; 95% confidence interval [CI], 1.431-5.951; P = .033), post-ARAT 3-month Hill type I (OR, 4.101; 95% CI, 1.812-9.121; P = .042), and AET <4% at 3 months (OR, 5.512; 95% CI, 1.451-7.621; P = .021).

      Conclusions

      ARAT is a feasible, safe, and effective therapy for early and mid-term treatment of GERD in patients without a sliding hiatal hernia. However, longer follow-up evaluations and randomized comparative studies are needed to clarify its real role. (Clinical trial registration number: NCT03548298.)

      Graphical abstract

      Abbreviations:

      AET (acid exposure time), ARAT (antireflux ablation therapy), ARMS (antireflux mucosectomy), CI (confidence interval), DM (DeMeester), EGJ (esophagogastric junction), ESD (endoscopic submucosa dissection), GERD-HRQL (Gastroesophageal Reflux Disease-Health-Related Quality of Life), H-APC (hybrid argon plasma coagulation), MLRM (multiple logistic regression model), OR (odds ratio), PPI (proton pump inhibitors), UE (upper endoscopy)
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      Linked Article

      • Endotherapy for gastroesophageal reflux disease: Another chance of success?
        Gastrointestinal EndoscopyVol. 92Issue 6
        • Preview
          Endotherapy for GERD has been a topic of interest over the past 25 years, with successive waves of enthusiasm and disappointment. However, until now, it has not really entered routine clinical practice. The first techniques to be investigated included injection of bulking agents (Enteryx, Boston Scientific, Marlborouth, Mass, USA), submucosal implants (Gatekeeper, Medtronic, Minneapolis, Minn, USA), suturing techniques (Endocinch, Bard and Plicator, NDO), injection of collagen, and radiofrequency of the muscle layer around the lower esophageal sphincter.
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