| Background and aim:Achalasia of Cardia(AC)is a chronic incurable esophageal motility disorder characterized by loss of esophageal peristalsis and failure of adequate lower esophageal sphincter(LES)relaxation,especially during swallowing.Although rare,it is currently the most common primary esophageal motility disorder,with an annual incidence of 0.5-1.6 per 100,000 persons and prevalence of around 10.8/100,000 persons.The disease manifests as symptoms of dysphagia to solids and liquids,regurgitation of food,retrosternal chest pain,weight loss,as well as cough and aspiration induced by food reflux.Diagnosis is suspected based on the clinical history and the "bird’s beak" appearance on barium swallow,but the diagnostic gold standard is abnormal peristalsis and failure of LES relaxation on high-resolution manometry(HRM).The general consensus of the literature suggests that achalasia represents a family of disorders rather than a single disease with a fixed pathophysiologic profile.The current understanding suggests that three factors determine the clinical phenotype including genetic predisposition,environmental triggers,and autoimmune myenteric plexitis.As the underlying etiology of achalasia remains unclear,there is currently no curative treatment for achalasia and all available treatments are hence palliative.Management of achalasia involves improving the esophageal outflow in order to provide symptomatic relief to patients.Conventional treatment modalities include oral pharmacologic therapies with long-acting nitrates and calcium channel blockers,botulinum toxin injection to LES,pneumatic dilation,and possibly surgical interventions(surgical myotomy,esophagectomy).Peroral endoscopic myotomy(POEM)is a novel minimally invasive technique that has emerged as the preferred option for the treatment of achalasia at many centers around the world.POEM was first introduced by Pasticha in 2007 in a swine model and was pioneered in 2010 into clinical care by Professor Inoue.Today,more than 7000 procedures have been performed worldwide and the number is increasing.According to the study of Inoue,patients with achalasia operated with extended myotomy(mean length 10.4 cm)had better symptom improvement,hence it is generally recommended that the length of myotomy should be greater than or equal to 10 cm.Esophageal manometry data of healthy volunteers revealed that the average length of LES is 3.2 cm and the Society of American Gastrointestinal and Endoscopic Surgeons(SAGES)recommends that the myotomy is continued up the esophagus for at least 4 cm and taken onto the stomach for approximately 2 cm.Is it really an imperative necessity to have a procedure of POEM with long myotomy?Few papers have reported the relativity between the lengths of myotomy in procedure of POEM and the outcome for achalasia patients.We speculated that peroral endoscopic short myotomy(myotomy length ≤7 cm)could also achieve a satisfied clinical safety and efficacy compared with long myotomy(myotomy length ≥7 cm).We conduct this prospective randomized controlled trial to investigate the safety and feasibility of the peroral endoscopic short myotomy,and to assess long term efficacy by using the Ecakrdt symptom score,HRM,and esophageal barium swallow examination.Methods:This study is a single-center,prospective,open-label,randomized controlled clinical trial.A total of 143 subjects diagnosed with achalasia were enrolled between July 2014 and October 2017.Ten subjects were withdrew because of loss to follow-up during the study,and the remain 133 subjects were randomized to short myotomy group(63 cases)and long myotomy group(70 cases).Symptoms were scored using the Eckardt symptom system(ESS)for weight loss,dysphagia,chest pain,and regurgitation.Barium swallow,endoscopy,and esophageal manometry were performed before and after POEM procedure.All subjects received Eckardt symptom scoring follow-up by telephone at 3 months,6 months,12 months,2 years,3 years after POEM procedure.Baseline characteristics,surgery-related parameters and validity index evaluation results were compared between the two groups.This trail was registered at www.clinicaltrials.gov(NCT03012854).Results:A total of 133 patients were included the trail and followed,with the median duration of 24 months(range 3 to 36 months).There was no significant difference in the baseline characteristics between the short myotomy group and the long myotomy group except the onset age(36.76±11.39 years vs.32.36±13.08 years,P=0.042)and visit age(42.2±11.78 years vs.36.99±13.65 years,P=0.020).The length of submucosal tunnel,distal esophageal myotomy,proximal gastric myotomy and the total myotomy in short myotomy group were significantly shorter than those in long myotomy group(P<0.05),and the mean operation duration of short myotomy group was significantly shorter than long myotomy group(47.2±20.1 min vs.61.6±25.2 min,P<0.001).The incidence of intraoperative complications(9.5%vs.5.8%)and postoperative gastroesophageal reflux disease(GERD)(9.5%vs.11.4%)were similar between the two groups(P>0.05).During follow-up,the barium swallow examination and LES resting pressure showed no significant difference between the two groups,while the LES integral relaxation pressure(IRP)in long myotomy group was significantly lower than that of short myotomy group(12.1±4.1 mmHg vs.14.2±4.5 mmHg,P=0.003).There was no significant difference in clinical cure rates at 3,6,12 months,2 years,and 3 years after POEM procedure(93.7%vs.95.7%;95.0%vs.98.5%;94.0%vs.100%;90.0%vs.100%;71.4%vs.100%;respectively)between the two groups(P>0.05).The curative efficacy of short-term and long-term between the two groups were all satisfied and comparable,with achievement of a high clinical curative rate.In subgroup analaysis of different type of achalasia,peroral endoscopic short myotomy can achieve a similar clinical efficacy compared with the long myotomy(P>0.05).Conclusion:POEM is an effective treatment for achalasia in both short term and long term post-operatively,with advantages of minimal invasion,less complication,quickly recovery.Peroral endoscopic short myotomy can achieve the same safety and both short-trem and long-trem clinical efficacy with the long myotomy,but significantly shorten the operation time.Thus peroral endoscopic short myotomy is a modified POEM with safety and efficacy. |
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