Clinical Trial: Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Universitätsklinikum Hamburg-Eppendorf

Current Primary Outcome: non-inferiority of POEM compared to LHM [ Time Frame: 2 years after treatment ]

treatment success defined as an Eckardt Score ≤ 3


Original Primary Outcome: non-inferiority of POEM compared to LHM [ Time Frame: 3 months after procedure ]

Primary outcome of the study ist the non-inferiority of POEM compared to LHM based on Lower esophageal sphincter pressure (LESP) on manometry after POEM compared to LHM


Current Secondary Outcome:

  • Eckhard symptom scores [ Time Frame: before,and 3 and 6 months, 1,3 and 5 years past procedure ]
    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 ]
    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 ]
    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 ]
    pH metry data, probe or Bravo
  • EGD findings [ Time Frame: 3 months and (optional) 2 and 5 years after therapy ]
    EGD findings to evaluate reflux effects after therapy
  • complication rate [ Time Frame: Baseline to five years past procedure ]
    complication rate (Adverse Events(AE))
  • Lower esophageal sphincter pressure (LESP) [ Time Frame: before, and 3 months, and 2 and 5 years post procedure ]
    Lower esophageal sphincter pressure (LESP) on manometry after POEM compared to LHM


Original Secondary Outcome:

  • Eckardt symptom scores [ Time Frame: before,and 3 and 6 months, 1,2,3 and 5 years past procedure ]
    Eckardt 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 ]
    clinical DeMeester score will be assessed to compare therapeutic side effects
  • Life Quality index [ Time Frame: before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure ]
    Life quality assessment (gastrointestinal LQ index by Eypasch, Wood-Dauphinee and Troidl) for individual success evaluation
  • pH metry [ Time Frame: 3 month after therapy ]
    pH metry data, probe or Bravo
  • EGD findings [ Time Frame: 3 months and (optional) 2 and 5 years after therapy ]
    EGD findings to evaluate reflux effects after therapy
  • complication rate [ Time Frame: Baseline to five years past procedure ]
    complication rate (Adverse Events(AE))


Information By: Universitätsklinikum Hamburg-Eppendorf

Dates:
Date Received: May 15, 2012
Date Started: December 2013
Date Completion: December 2019
Last Updated: May 3, 2017
Last Verified: May 2017