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Войти в исследования Gastrointestinal endoscopy · 2020
Clinical feasibility of a new antireflux ablation therapy on gastroesophageal reflux disease (with video).
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Hernández Mondragón Oscar Víctor, Zamarripa Mottú Raúl Antonio, García Contreras Luís Fernando, Gutiérrez Aguilar Raul Alberto, Solórzano Pineda Omar Michel, Blanco Velasco Gerardo, Murcio Perez Enrique
Аннотация
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.).
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.).