Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia

Summary

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.

Conditions

• Achalasia

Interventions

PROCEDURE

Peroral Endoscopic Myotomy (POEM)

After lavage, measure gastro-esophageal junction (GEJ) in cm from mouth piece. Determine entry point 12-14cm above GEJ at the lesser curvature site, inject 10ml coloured saline, create entry point. Advance endoscope into the submucosa, dissect the submucosal tunnel up to 2-3cm into the cardia. Dissect the submucosa close to the muscularis and check endoluminally for the direction of the lesser curvature, sufficient extension onto the cardia and mucosal integrity. After tunnel completion flush with gentamycin and saline. Start myotomy from proximally to distally starting 4-5cm below the mucosal entry site; the inner circular muscle layer should be fully dissected especially at the cardia for good symptomatic results. It is vital that the mucosa of the tubular esophagus remains intact. Extend myotomy at least 2cm onto the cardia. After completion check for mucosal integrity and opening of the distal esophageal sphincter. Close the entry point with clips from distal to proximal.

PROCEDURE

Laparoscopic Heller Myotomy (LHM)

Use five trocar technique with patient in the French position as for laparoscopic anti-reflux procedures. Establish 12-15 mm Hg pneumoperitoneum. Use left paramedian trocar for camera, two lateral trocars for elevating liver and retraction of stomach and two trocars for dissection and suturing. Use of robotic surgery devices is allowed. Divide phrenoesophageal ligament starting on the right and mobilize distal esophagus on the lateral and anterior side. Identify and spare anterior vagal nerve. Perform myotomy by dividing both muscle-layers extending at least 6 cm above gastroesophageal junction and at least 2-3 cm inferiorly over stomach. Perform extent downwards after dividing epiphrenic fat pad overlying cardia. Measure myotomy length. Peroperative endoscopy check is advisable. Perform anterior fundoplication according to Dor. Only if necessary mobilize fundus of the stomach by dividing short gastric vessels. Suture fundus to both cut edges of myotomy, using non-resorbable material.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• University Hospital Prague (IKEM), Prague, Czech Republic

  collaborator UNKNOWN

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Istituto Clinico Humanitas

  collaborator OTHER

• Wuerzburg University Hospital

  collaborator OTHER

• University Hospital Augsburg

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• Thomas Roesch, Prof. · Interdisciplinary Endoscopy Department and Clinic, University Hospital Hamburg-Eppendorf, Germany

• Paul Fockens, Prof. · Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam; Netherlands

• Bengt Håkanson, Prof. · Department of Surgery, Karolinska University Hospital, Stockholm, Sweden

• Guy Boeckxstaens, Prof. · Universitaire Ziekenhuizen KU Leuven

• C.T. Germer, Prof. · Wuerzburg University Hospital

• Riccardo Repici, Prof. · Istituto Clinico Humanitas, Rozzano, Italy

• Uberto Fumagalli, Prof. · Istituto Clinico Humanitas, Rozzano, Italy

• Julius Spicak, Prof. · University Hospital Prague, Prague, Czech Republic

• Helmut Messmann, Prof. · Department for Internal Medicine III, Klinikum Augsburg, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2022-05-30

Completion

2023-05-30

Countries

• Belgium
• Czechia
• Germany
• Italy
• Netherlands
• Sweden

Study Locations