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Pneumatic dilatation and laparoscopic Heller myotomy with partial fundoplication are both commonly performed for the treatment of achalasia. It is not known whether one procedure is superior with respect to disease-specific quality of life.

We randomly assigned 50 healthy persons aged 18 years or older who were newly diagnosed with achalasia to either laparoscopic Heller myotomy with partial fundoplication (HM) or to pneumatic dilatation (PD) with a 30mm balloon at 4 Canadian cities (Kingston, Toronto, Edmonton and Calgary). The primary outcome measure was the Achalasia Severity Questionnaire (ASQ) score—a validated disease-specific measure of health related quality of life—at 1 year after treatment. Secondary outcome measures included retreatment, generic quality of life (SF-36), achalasia symptoms, esophageal emptying quantified by timed barium esophagram (TBE), and abnormal 24 hour ambulatory esophageal pH monitoring (24h pH, as defined by pH<4.0 for >4.0% of the total time). We enrolled sufficient subjects to detect a clinically significant difference between treatment groups (20 points in the 0-100 ASQ scale). Patients were analyzed according to their assigned treatment group.

Follow up data were available for 22 subjects who were initially assigned to PD and 23 who were assigned to HM. There were no major differences between the groups at baseline. Five subjects required re-treatment, all of whom were initially assigned to PD (22.7%, 95% confidence interval [CI] 7.8% to 45.4% as compared with 0%, 95% CI 0% to 14.8%, P=0.02). The mean improvement in ASQ at 1 year, analyzing the last pre-re-treatment observation for re-treated subjects, was 20.9 (standard deviation [SD] 18.0) among PD patients as compared with 27.5 (SD 21.1) among HM patients (mean difference 6.6, 95% CI -5.2 to 18.4). Six months after treatment, the mean improvement in TBE percent emptying after 5 minutes was 30.4% among PD patients as compared with 19.7% among HM patients (mean difference 10.7%, 95% CI -16.7% to 38.2%). Among patients who had 24h pH at 6 months, none treated by HM had abnormal acid exposure (95% CI 0% to 16.8%) as compared with 9.1% (95% CI 1.1% to 29.2 %) among PD patients (P=0.17). None of the changes in measured symptoms or quality of life scores were significantly different between treatment groups. The reduction in lower esophageal sphincter resting pressure was significantly larger among patients assigned to HM (25.5 mmHg [SD14.4] as compared with 14.2 mmHg [SD 17.6], mean difference 11.3 mmHg, 95% CI 0.4 mmHg to 22.2 mmHg).

Among healthy patients newly diagnosed with achalasia, HM does not result in a clinically significant improvement in quality of life as compared with PD. Patients treated initially by PD are significantly more likely to require re-treatment as compared with patients treated initially by HM.