Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia
| Autor: | Boeckxstaens, G.E., Annese, V., Des Varannes, S.B., Chaussade, S., Costantini, M., Cuttitta, A., Elizalde, J..I., Fumagalli, U., Gaudric, M., Rohof, W.O., Smout, A.J., Tack, J., Zwinderman, A.H., Zaninotto, G., Busch, O.R., Lei, A., Bartelsman, J., Hirsch, D., Klinkenberg Knol, E..C., Cuesta, M.A., Simmermacher, R..K., Kuipers, E.J., Bonjer, H..J., Masclee, A..A., Ringers, J., Lerut, A., Metman, E..H., Huten, N., Letessier, E., Dousset, B., Pera, M., Perez de la Serna, J., Malesci, A., Andriulli, A., Scaramuzzi, G., De Santo, E. |
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| Přispěvatelé: | AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, Other departments, APH - Amsterdam Public Health, Epidemiology and Data Science, CCA -Cancer Center Amsterdam, Surgery, Interne Geneeskunde, RS: NUTRIM - R2 - Gut-liver homeostasis |
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Myotomy
Adult Male medicine.medical_specialty Settore MED/09 - Medicina Interna medicine.medical_treatment Perforation (oil well) Achalasia Fundoplication Kaplan-Meier Estimate lower Esophageal Sphincter Lower Catheterization Esophagus Risk Factors medicine Humans medicine (all) Heller myotomy Settore MED/12 - Gastroenterologia Chi-Square Distribution Esophageal Perforation Esophageal disease business.industry General Medicine Middle Aged medicine.disease Dysphagia Surgery Intention to Treat Analysis Esophageal Achalasia Settore MED/18 - Chirurgia Generale medicine.anatomical_structure Treatment Outcome Retreatment Balloon dilation esophageal sphincter Female Laparoscopy medicine.symptom business adult chi-square distribution esophageal achalasia esophageal perforation esophageal sphincter lower esophagus female follow-up studies humans intention to treat analysis kaplan-meier estimate male middle aged retreatment risk factors treatment outcome catheterization fundoplication laparoscopy Follow-Up Studies |
| Zdroj: | New England journal of medicine, 364(19), 1807-1816. Massachussetts Medical Society New England Journal of Medicine, 364(19), 1807-1816. MASSACHUSETTS MEDICAL SOCIETY |
| ISSN: | 0028-4793 |
| DOI: | 10.1056/nejmoa1010502 |
| Popis: | BACKGROUND: Many experts consider laparoscopic Heller's myotomy (LHM) to be superior to pneumatic dilation for the treatment of achalasia, and LHM is increasingly considered to be the treatment of choice for this disorder.METHODS: We randomly assigned patients with newly diagnosed achalasia to pneumatic dilation or LHM with Dor's fundoplication. Symptoms, including weight loss, dysphagia, retrosternal pain, and regurgitation, were assessed with the use of the Eckardt score (which ranges from 0 to 12, with higher scores indicating more pronounced symptoms). The primary outcome was therapeutic success (a drop in the Eckardt score to '3) at the yearly follow-up assessment. The secondary outcomes included the need for retreatment, pressure at the lower esophageal sphincter, esophageal emptying on a timed barium esophagogram, quality of life, and the rate of complications.RESULTS: A total of 201 patients were randomly assigned to pneumatic dilation (95 patients) or LHM (106). The mean follow-up time was 43 months (95% confidence interval [CI], 40 to 47). In an intention-to-treat analysis, there was no significant difference between the two groups in the primary outcome; the rate of therapeutic success with pneumatic dilation was 90% after 1 year of follow-up and 86% after 2 years, as compared with a rate with LHM of 93% after 1 year and 90% after 2 years (P=0.46). After 2 years of follow-up, there was no significant between-group difference in the pressure at the lower esophageal sphincter (LHM, 10 mm Hg [95% CI, 8.7 to 12]; pneumatic dilation, 12 mm Hg [95% CI, 9.7 to 14]; P=0.27); esophageal emptying, as assessed by the height of barium-contrast column (LHM, 1.9 cm [95% CI, 0 to 6.8]; pneumatic dilation, 3.7 cm [95% CI, 0 to 8.8]; P=0.21); or quality of life. Similar results were obtained in the per-protocol analysis. Perforation of the esophagus occurred in 4% of the patients during pneumatic dilation, whereas mucosal tears occurred in 12% during LHM. Abnormal exposure to esophageal acid was observed in 15% and 23% of the patients in the pneumatic-dilation and LHM groups, respectively (P=0.28).CONCLUSIONS: After 2 years of follow-up, LHM, as compared with pneumatic dilation, was not associated with superior rates of therapeutic success. (European Achalasia Trial Netherlands Trial Register number, NTR37, and Current Controlled Trials number, ISRCTN56304564.). |
| Databáze: | OpenAIRE |
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