Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial (POEM rcpmt)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Klinikum Augsburg
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Karolinska University Hospital
University Hospital Prague (IKEM), Prague, Czech Republic
Universitaire Ziekenhuizen Leuven
Istituto Clinico Humanitas
Wuerzburg University Hospital
Information provided by (Responsible Party):
Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01601678
First received: May 15, 2012
Last updated: January 7, 2016
Last verified: September 2015
  Purpose
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.

Condition Intervention
Achalasia
Procedure: Peroral Endoscopic Myotomy (POEM)
Procedure: Laparoscopic Heller Myotomy (LHM)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • non-inferiority of POEM compared to LHM [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]
    treatment success defined as an Eckardt Score ≤ 3


Secondary Outcome Measures:
  • Eckhard symptom scores [ Time Frame: before,and 3 and 6 months, 1,3 and 5 years past procedure ] [ Designated as safety issue: No ]
    Eckhard symptom scores will be assessed to evaluate individual therapy success

  • reflux symptom assessment [ Time Frame: before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure ] [ Designated as safety issue: No ]
    clinical DeMeester score will be assessed to compare therapeutic side effects

  • Life Quality index [ Time Frame: before, and 3 months, and 2 and 5 years post procedure ] [ Designated as safety issue: No ]
    Life quality assessment (gastrointestinal LQ index by Eypasch, Wood-Dauphinee and Troidl) for individual success evaluation

  • pH metry [ Time Frame: 3 months and (optional) 2 and 5 years after therapy ] [ Designated as safety issue: No ]
    pH metry data, probe or Bravo

  • EGD findings [ Time Frame: 3 months and (optional) 2 and 5 years after therapy ] [ Designated as safety issue: No ]
    EGD findings to evaluate reflux effects after therapy

  • complication rate [ Time Frame: Baseline to five years past procedure ] [ Designated as safety issue: Yes ]
    complication rate (Adverse Events(AE))

  • Lower esophageal sphincter pressure (LESP) [ Time Frame: before, and 3 months, and 2 and 5 years post procedure ] [ Designated as safety issue: No ]
    Lower esophageal sphincter pressure (LESP) on manometry after POEM compared to LHM


Enrollment: 240
Study Start Date: December 2013
Estimated Study Completion Date: December 2019
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Peroral Endoscopic Myotomy POEM
Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the POEM therapy group
Procedure: Peroral Endoscopic Myotomy (POEM)
Endoluminal submucosal myotomy of the distal esophagus/lower esophageal sphincter for treatment of achalasia(see Inoue et al. Endoscopy 2010) POEM procedure steps: Lavage, entry point 12-14cm above GEJ at the lesser curvature site, Inject 10ml saline with methylene blue, create 2cm entry point, advance endoscope into the submucosa, repeated submucosal injection and dissection of the submucosal tunnel up to 2-3cm into the cardia, dissect the submucosa close to the muscularis with repeated checks endoluminally, after completion of the submucosal tunnel flush with gentamycin, perform myotomy from proximal to distal starting 4-5cm below the entry point down to at least 2cm onto the cardia, after complete myotomy check for mucosal integrity, close the entry point with clips from distal to proximal
Active Comparator: Laparoscopic Heller Myotomy LHM
Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the LHM therapy group.
Procedure: Laparoscopic Heller Myotomy (LHM)
laparoscopic myotomy of the lower esophageal sphincter as with standard achalasia therapy: after opening the phren-oesophageal ligament to mobilise distal esophagus distally and proximally, a 1.5- 2cm myotomy at the cardia with an approximately 6-8cm myotomy extension into the distal esophagus is made. As anti reflux procedure, a Dor hemifundoplication is preferred

Detailed Description:

Peroral Endoscopic Myotomy myotomy (POEM) has been recently introduced for treatment of achalasia, based on technical developments from NOTES (natural orifice translumenal surgery). The technique uses a submucosal esophageal tunnel through which a distal esophageal myotomy down to the proximal stomach is performed. Single center studies demonstrate promising short-term results of POEM for the treatment of achalasia, leading us to hope for a similar success rate along with reduced patient discomfort. For POEM to be integrated inot clinical routine, comparative data regarding safety and efficacy are necessary. This study intends to investigate the feasibility, safety and efficacy of Peroral Endoscopic Myotomy (POEM)for the treatment of achalasia compared to laparoscopic surgical therapy (laparoscopic Heller Myotomy)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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagogastroduodenoscopy which are 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 achalasia treatment with surgery
  • Patients with liver cirrhosis and/or esophageal varices
  • Active esophagitis
  • Eosinophilic esophagitis
  • Severe Candida esophagitis
  • Barrett's esophagus
  • Pregnancy
  • Stricture of the esophagus
  • Malignant or premalignant esophageal lesion
  • Hiatal hernia > 1cm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601678

Locations
Czech Republic
University Hospital Prague (IKEM)
Prague, Czech Republic
Germany
Universitätsklinikum Eppendorf
Hamburg, Germany, 20246
Italy
Istituto Clinico Humanitas
Rozzano, Italy
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Sweden
Ersta Hospital and Karolinska University Hospital
Stockholm, Sweden, S141 86
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Klinikum Augsburg
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Karolinska University Hospital
University Hospital Prague (IKEM), Prague, Czech Republic
Universitaire Ziekenhuizen Leuven
Istituto Clinico Humanitas
Wuerzburg University Hospital
Investigators
Study Director: Thomas Roesch, Prof. Interdisciplinary Endoscopy Department and Clinic, University Hospital Hamburg-Eppendorf, Germany
Principal Investigator: Helmut Messmann, Prof. Department for Internal Medicine III, Klinikum Augsburg, Germany
Principal Investigator: Paul Fockens, Prof. Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam; Netherlands
Principal Investigator: Lars Lundell, Prof. Department of Surgery, Karolinska University Hospital, Stockholm, Sweden
Principal Investigator: Julius Spicak, Prof. University Hospital Prague (IKEM), Prague, Czech Republic, Czech Republic
Principal Investigator: Guy Boeckxstaens, Prof. University Hospital Leuven, Leuven, Belgium
Principal Investigator: Riccardo Repici, Prof. Istituto Clinico Humanitas, Rozzano, Italy
Principal Investigator: Burkhard H A von Rahden, PD Dr. Wuerzburg University Hospital
  More Information

Publications:

Responsible Party: Prof. Dr. Thomas Rösch, Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg-Eppendorf, Endoscopy department, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01601678     History of Changes
Other Study ID Numbers: POEM rcpmt 
Study First Received: May 15, 2012
Last Updated: January 7, 2016
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Achalasia
Heller Myotomy
Dysphagia
Peroral Endoscopic Myotomy

Additional relevant MeSH terms:
Esophageal Achalasia
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 01, 2016