Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia (POEMrct)

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Achalasia

Treatments: Procedure: Peroral Endoscopic Myotomy (POEM); Procedure: Laparoscopic Heller Myotomy (LHM)

Study type: Interventional

Funder types: Other

Identifiers

NCT01601678

POEM vs. LHM

PV 4133 (Registry Identifier)

Details and patient eligibility

About

Achalasia is a rare neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus leading to dysphagia, regurgitation, and chest pain. therapies for achalasia consist of endoscopic balloon dilatation (EBD) and botulinum toxin injection (EBTI), or surgical Treatment via i Heller Myotomy; surgery is nowadays mostly performed via the laparoscopic approach. Surgical therapy demonstrated superior treatment efficacy compared to EBD and EBTI. Recently, an endoscopic means to perform myotomy via a submucosal tunnel has been developed, namely PerOral Endoscopic Myotomy (POEM). Uncontrolled studies have indicated a symptomatic success rate of >90% for POEM in short term follow-ups.The aim of this study is to compare short and long-term feasibility, safety and efficacy of endoscopic (POEM) with laparoscopic myotomy (Heller myotomy) in the treatment of achalasia.

Full description

Achalasia is considered a primary esophageal motility disorder which is defined as an insufficient relaxation of the lower esophageal sphincter. Incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus are characteristics of achalasia. Incidence peaks between ages 20 to 40. The most commonly reported symptoms are dysphagia (both for solids and liquids), regurgitation, and chest pain. The diagnosis is established with esophageal manometry and barium swallow radiographic studies and also with endoscopy being performed to exclude neoplastic or inflammatory diseases. Endoscopic therapies consist of either balloon dilatation (EBD) or Botulinum toxin injection (EBTI). The surgical treatment for achalasia is Heller Myotomy, nowadays almost exclusively performed laparoscopically.Superior to EBD and EBTI, surgical myotomy has shown sustained therapeutic efficacy in approximately 90% of patients which may be especially relevant for young patients with achalasia.

Recently an endoscopic technique to create myotomy via a submucosal tunnel has been developed, named PerOral Endoscopic Myotomy (POEM). The technique was first reported by Pasricha et al. in a porcine study, and Inoue et al. later reported the first clinical results in achalasia patients which showed significantly reduced dysphagia symptom scores and decreased resting lower esophageal sphincter (LES) pressures in 17 patients with a mean follow-up of 5 months . No serious complications related to POEM were encountered in this initial single-center trial. Several smaller pilot studies from Asia, Europe and USA have replicated the promising results regarding feasibility, safety and short-term efficacy,leading us to hope for a similar success rate along with reduced patient discomfort At present, POEM has the potential to be the first scarless flexible endosurgical intervention to become an established clinical treatment.The technique uses a submucosal esophageal tunnel through which a distal esophageal myotomy down to the proximal stomach is performed. For POEM to be integrated into clinical routine, comparative data regarding safety and efficacy are necessary.Our study group intends to compare safety and long-term efficacy of POEM to laparoscopic Heller myotomy, the current gold-Standard, in a non-inferiority design.

Patients with symptomatic achalasia and medical indication for interventional therapy will be randomized to either POEM therapy or standard laparoscopic Heller myotomy (with anti-reflux procedure)(LHM). They will be followed up closely in a defined time pattern evolving individual life quality and achalasia scores as well as clinical scores and diagnostics over a period of 5 years.

Due to considerations concerning the comparability to other achalsia Trials (Boeckxstaens,NEJM 2011), in November 2012 primary outcome has been changed to Eckardt Score instead of lower sphicter pressure. Amendment was done before patient inclusion started. Sample size was not affected by amendment.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with symptomatic achalasia with an Eckardt score of > 3 and pre-op barium swallow, manometry and esophagogastroduodenoscopy consistent with the diagnosis
• Persons of age > 18 years with medical indication for surgical myotomy or EBD
• Signed written Informed Consent

Exclusion criteria

• Patients with previous surgery of the stomach or esophagus
• Patients with known coagulopathy
• Previous surgical achalasia treatment
• Patients with liver cirrhosis and/or esophageal varices
• Active esophagitis
• Eosinophilic esophagitis
• Barrett's esophagus
• Pregnancy
• Stricture of the esophagus
• Malignant or premalignant esophageal lesion
• Severe Candida esophagitis
• Hiatal hernia > 1cm
• Extensive tortuous dilatation (>7cm luminal diameter, S shape) of the esophagus
• Advanced malignant tumor with prognosis < 2 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Peroral Endoscopic Myotomy POEM

Active Comparator group

Description:

Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the POEM therapy group

Treatment:

Procedure: Peroral Endoscopic Myotomy (POEM)

Laparoscopic Heller Myotomy LHM

Active Comparator group

Description:

Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the LHM therapy group.

Treatment:

Procedure: Laparoscopic Heller Myotomy (LHM)