Endoscopic Peroral Myotomy for Treatment of Achalasia

June 5, 2019 updated by: Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

Endoscopic Peroral Myotomy for Treatment of Achalasia: Multicenter Study

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center s

70 patients will be enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the Eckardt symptom score at 3 month after peroral endoscopic myotomy.

Primary outcome:

-Eckhard symptom score 3 month after therapy.

Secondary outcomes:

Lower esophageal sphincter pressure at 3 month after therapy. Reflux symptoms at 3 month after therapy. For this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophago-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion.

A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Clinic for Visceral- and Thoracic Surgery, McGill University Health Centre
  • Germany
      • Frankfurt am Main, Germany, 60431
        • Clinic for Visceral-, Vasular- and Thoracic Surgery, Markus-Krankenhaus
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Department of Gastroenterology and Hepatology, Academic Medical Center
  • Switzerland
      • Zürich, Switzerland
        • Klinik für Gastroenterologie, USZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Endoscopic balloon dilatation
  • 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
  • Barrett's esophagus
  • Pregnancy
  • Stricture of the esophagus
  • Malignant or premalignant esophageal lesion
  • Candida esophagitis
  • Hiatal hernia > 2cm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peroral endoscopic myotomy

Patients with achalasia who are designed to either have balloon dilatation or botulinum toxine injection, or to have surgical intervention (Heller myotomy) for therapy.

Peroral endoscopic myotomy: A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.
Procedure: Endoscopic Peroral Myotomy
Endoscopic peroral myotomy: A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eckhard symptom score at 3 month after peroral endoscopic myotomy
Time Frame: Score is evaluated at 3 month after peroral endoscopic myotomy
Validated symptom score based on dysphagia, pain, regurgitation and weight loss
Score is evaluated at 3 month after peroral endoscopic myotomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower esophageal sphincter pressure
Time Frame: Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy
Manometry study
Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy
Reflux Symptoms
Time Frame: Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy
Symptoms as reported by the patient
Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

May 26, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Actual)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKE HH Endoscopy PV3725mc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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