Pneumatic Dilatation or Surgical Myotomy for Achalasia

April 4, 2016 updated by: Lars Lundell, Karolinska University Hospital

Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up

Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.

During follow up patients have been interviewed with regular intervals, by use validated questionnaires. The level of symptom control has been assessed as well as the scoring cumulative incidence of treatment failures.

Health Related Quality of Life (HRQL) has been regularly checked.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

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

  • Sweden
      • Göteborg, Sweden, 41132
        • Sahlgrenska University Hospital

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly diagnosed achalasia
  • Age 18-80 years
  • Informed consent

Exclusion Criteria:

  • Previous treatment for achalasia.
  • Stage IV achalasia.
  • Unwillingness to participate.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pneumatic dilatation
Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence.
Procedure: Pneumatic dilatation
Active Comparator: Surgical myotomy
Laparoscopic myotomy and subsequent follow up.
Procedure: Laparoscopic myotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failures
Time Frame: At least five years after intervention
Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.
At least five years after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysphagia scoring
Time Frame: At least five years after intervention
Dysphagia score according to standardized, validated scoring system.
At least five years after intervention
Health Related Quality of Life
Time Frame: At least five years after intervention.
Universally adopted and validated instruments are used.
At least five years after intervention.
Direct medical costs.
Time Frame: At least five years after intervention.
Charges for the average hospital in respective countries.
At least five years after intervention.

Collaborators and Investigators

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

Sponsor

Karolinska University Hospital

Collaborators

Sahlgrenska University Hospital, Sweden

Investigators

  • Study Chair: Lars Lundell, Professor, Karolinska University Hospital

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

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

January 1, 2000

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S500-00

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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