Jan Martinek1,2,3, Hana Svecova4, Zuzana Vackova4, Radek Dolezel5, Ondrej Ngo6, Jana Krajciova4, Eva Kieslichova7, Radim Janousek8, Alexander Pazdro9, Tomas Harustiak9, Lucie Zdrhova10, Pavla Loudova11, Petr Stirand4, Julius Spicak4. 1. Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, IKEM, Videnska 1921, 140 21, Prague 4, Czech Republic. jan.martinek@volny.cz. 2. Institute of Physiology, Charles University, Prague, Czech Republic. jan.martinek@volny.cz. 3. Faculty of Medicine, Ostrava University, Ostrava, Czech Republic. jan.martinek@volny.cz. 4. Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, IKEM, Videnska 1921, 140 21, Prague 4, Czech Republic. 5. Department of Surgery, Charles University, Military University Hospital, Prague, Czech Republic. 6. Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic. 7. Department of Anesthesiology and Intensive Care, IKEM, Prague, Czech Republic. 8. Department of Radiology, IKEM, Prague, Czech Republic. 9. 3rd Department of Surgery, First Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic. 10. Department of Internal Medicine, University Hospital Plzen, Charles University, Pilsen, Czech Republic. 11. Department of Gastroenterology, Hospital Kolin, Kolin, Czech Republic.
Abstract
BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) is becoming a standard treatment for achalasia. Long-term efficacy and the rate of post-POEM reflux should be further investigated. The main aim of this study was to analyze safety and mid-term (12 and 24 months) clinical outcomes of POEM. METHODS: Data on single tertiary center procedures were collected prospectively. The primary outcome was treatment success defined as an Eckardt score < 3 at 12 and 24 months. A total of 155 consecutive patients with achalasia underwent POEM; 133 patients were included into the analysis (22 patients will be analyzed separately as part of a multicenter randomized clinical trial). RESULTS:POEM was successfully completed in 132 (99.2%) patients, and the mean length of the procedure was 69.8 min (range 31-136). One patient underwent a drainage for pleural effusion; no other serious adverse events occurred. Treatment success at 3, 12, and 24 months was observed in 95.5% (CI 89.6-98.1), 93.4% (86.5-96.8), and 84.0% (71.4-91.4) of patients, respectively. A total of 11 patients (8.3%) reported initial treatment failure (n = 5) or later recurrence (n = 6). The majority of relapses occurred in patients with achalasia type I (16.7 vs. 1.1% achalasia type II vs. 0% achalasia type III; p<0.05). At 12 months, post-POEM reflux symptoms were present in 29.7% of patients. At 3 months, mild reflux esophagitis was diagnosed in 37.6% of patients, and pathological gastroesophageal reflux was detected in 41.5% of patients. A total of 37.8% of patients had been treated with a proton pump inhibitor. CONCLUSION:POEM resulted in greater than 90% treatment success at 12 months which tends to decrease to 84% after 2 years. More than one-third of the patients had mild reflux symptoms and/or mild esophagitis.
RCT Entities:
BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) is becoming a standard treatment for achalasia. Long-term efficacy and the rate of post-POEM reflux should be further investigated. The main aim of this study was to analyze safety and mid-term (12 and 24 months) clinical outcomes of POEM. METHODS: Data on single tertiary center procedures were collected prospectively. The primary outcome was treatment success defined as an Eckardt score < 3 at 12 and 24 months. A total of 155 consecutive patients with achalasia underwent POEM; 133 patients were included into the analysis (22 patients will be analyzed separately as part of a multicenter randomized clinical trial). RESULTS: POEM was successfully completed in 132 (99.2%) patients, and the mean length of the procedure was 69.8 min (range 31-136). One patient underwent a drainage for pleural effusion; no other serious adverse events occurred. Treatment success at 3, 12, and 24 months was observed in 95.5% (CI 89.6-98.1), 93.4% (86.5-96.8), and 84.0% (71.4-91.4) of patients, respectively. A total of 11 patients (8.3%) reported initial treatment failure (n = 5) or later recurrence (n = 6). The majority of relapses occurred in patients with achalasia type I (16.7 vs. 1.1% achalasia type II vs. 0% achalasia type III; p<0.05). At 12 months, post-POEM reflux symptoms were present in 29.7% of patients. At 3 months, mild reflux esophagitis was diagnosed in 37.6% of patients, and pathological gastroesophageal reflux was detected in 41.5% of patients. A total of 37.8% of patients had been treated with a proton pump inhibitor. CONCLUSION: POEM resulted in greater than 90% treatment success at 12 months which tends to decrease to 84% after 2 years. More than one-third of the patients had mild reflux symptoms and/or mild esophagitis.
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