Dataset Information

Laparoscopic Heller myotomy is not superior to pneumatic dilation in the management of primary achalasia: Conclusions of a systematic review and meta-analysis of randomized controlled trials.

ABSTRACT:

Background

Achalasia is an esophageal motility disorder, of unknown cause, which results in increased lower esophageal sphincter tone and symptoms of difficulty swallowing. Current major therapeutic options include laparoscopic Heller myotomy (LHM) and pneumatic dilation (PD). We undertake a systematic review comparing the efficacy and safety of these 2 treatments in the treatment of esophageal achalasia.

Methods

PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched for randomized controlled trial investigating LHM versus PD in the treatment of primary achalasia. The primary outcome was symptom remission rates. The Mantel-Haenszel method with fixed-effect or random-effects model was used to calculate relative risks and 95% confidence intervals (CIs).

Results

Five studies involving 498 participants were included. The cumulative remission rate was significantly higher with LHM at 3 months and 1 year (short-term), with a risk ratio of 1.16 (95% CI 1.01-1.35, P?=?0.04) and 1.14 (95% CI 1.02-1.27, P?=?0.02), respectively. There were no significant differences between LHM and PD in 2-year and 5-year remission rate (long-term), with a risk ratio of 1.05 (95% CI 0.91-1.22, P?=?0.49) and 1.17 (95% CI 0.84-1.64, P?=?0.34), respectively. Rates of major mucosal tears requiring subsequent intervention with LHM were significantly lower than those of esophageal perforation with PD requiring postprocedural medical or surgical therapy, with a risk ratio of 0.25 (95% CI 0.08-0.81, P?=?0.02). Postprocedural rates of gastroesophageal reflux, lower esophageal sphincter pressures, and quality of life scores did not differ in trials with sufficient data.

Conclusions

There were no significant differences between LHM and PD in 2-year and 5-year remission rate. This study indicates that either treatment can be proposed as initial treatment for achalasia.

SUBMITTER: Cheng JW

PROVIDER: S-EPMC5319488 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Laparoscopic Heller myotomy is not superior to pneumatic dilation in the management of primary achalasia: Conclusions of a systematic review and meta-analysis of randomized controlled trials.

Cheng Ji-Wei JW Li Yin Y Xing Wen-Qun WQ Lv Hong-Wei HW Wang Hao-Ran HR

Medicine 20170201 7

<h4>Background</h4>Achalasia is an esophageal motility disorder, of unknown cause, which results in increased lower esophageal sphincter tone and symptoms of difficulty swallowing. Current major therapeutic options include laparoscopic Heller myotomy (LHM) and pneumatic dilation (PD). We undertake a systematic review comparing the efficacy and safety of these 2 treatments in the treatment of esophageal achalasia.<h4>Methods</h4>PubMed, Embase, and Cochrane Central Register of Controlled Trials w ...[more]

PMID: 28207499

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Project description:ImportanceCase series suggest favorable results of peroral endoscopic myotomy (POEM) for treatment of patients with achalasia. Data comparing POEM with pneumatic dilation, the standard treatment for patients with achalasia, are lacking.ObjectiveTo compare the effects of POEM vs pneumatic dilation as initial treatment of treatment-naive patients with achalasia.Design, setting, and participantsThis randomized multicenter clinical trial was conducted at 6 hospitals in the Netherlands, Germany, Italy, Hong Kong, and the United States. Adult patients with newly diagnosed achalasia and an Eckardt score greater than 3 who had not undergone previous treatment were included. The study was conducted between September 2012 and July 2015, the duration of follow-up was 2 years after the initial treatment, and the final date of follow-up was November 22, 2017.InterventionsRandomization to receive POEM (n = 67) or pneumatic dilation with a 30-mm and a 35-mm balloon (n = 66), with stratification according to hospital.Main outcomes and measuresThe primary outcome was treatment success (defined as an Eckardt score ≤3 and the absence of severe complications or re-treatment) at the 2-year follow-up. A total of 14 secondary end points were examined among patients without treatment failure, including integrated relaxation pressure of the lower esophageal sphincter via high-resolution manometry, barium column height on timed barium esophagogram, and presence of reflux esophagitis.ResultsOf the 133 randomized patients, 130 (mean age, 48.6 years; 73 [56%] men) underwent treatment (64 in the POEM group and 66 in the pneumatic dilation group) and 126 (95%) completed the study. The primary outcome of treatment success occurred in 58 of 63 patients (92%) in the POEM group vs 34 of 63 (54%) in the pneumatic dilation group, a difference of 38% ([95% CI, 22%-52%]; P < .001). Of the 14 prespecified secondary end points, no significant difference between groups was demonstrated in 10 end points. There was no significant between-group difference in median integrated relaxation pressure (9.9 mm Hg in the POEM group vs 12.6 mm Hg in the pneumatic dilation group; difference, 2.7 mm Hg [95% CI, -2.1 to 7.5]; P = .07) or median barium column height (2.3 cm in the POEM group vs 0 cm in the pneumatic dilation group; difference, 2.3 cm [95% CI, 1.0-3.6]; P = .05). Reflux esophagitis occurred more often in the POEM group than in the pneumatic dilation group (22 of 54 [41%] vs 2 of 29 [7%]; difference, 34% [95% CI, 12%-49%]; P = .002). Two serious adverse events, including 1 perforation, occurred after pneumatic dilation, while no serious adverse events occurred after POEM.Conclusions and relevanceAmong treatment-naive patients with achalasia, treatment with POEM compared with pneumatic dilation resulted in a significantly higher treatment success rate at 2 years. These findings support consideration of POEM as an initial treatment option for patients with achalasia.Trial registrationNetherlands Trial Register number: NTR3593.

Dataset Information

Laparoscopic Heller myotomy is not superior to pneumatic dilation in the management of primary achalasia: Conclusions of a systematic review and meta-analysis of randomized controlled trials.

Background

Methods

Results

Conclusions

Publications

Laparoscopic Heller myotomy is not superior to pneumatic dilation in the management of primary achalasia: Conclusions of a systematic review and meta-analysis of randomized controlled trials.

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