Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pneumatic Dilatation or Surgical Myotomy for Achalasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02086669
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : April 5, 2016
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Lars Lundell, Karolinska University Hospital

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

Condition or disease Intervention/treatment Phase
Achalasia Procedure: Pneumatic dilatation Procedure: Laparoscopic myotomy Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up
Study Start Date : January 2000
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Dysphagia scoring [ Time Frame: At least five years after intervention ]
    Dysphagia score according to standardized, validated scoring system.

  2. Health Related Quality of Life [ Time Frame: At least five years after intervention. ]
    Universally adopted and validated instruments are used.

  3. Direct medical costs. [ Time Frame: At least five years after intervention. ]
    Charges for the average hospital in respective countries.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086669


Locations
Layout table for location information
Sweden
Sahlgrenska University Hospital
Göteborg, Sweden, 41132
Sponsors and Collaborators
Karolinska University Hospital
Sahlgrenska University Hospital, Sweden
Investigators
Layout table for investigator information
Study Chair: Lars Lundell, Professor Karolinska University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Lars Lundell, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02086669    
Other Study ID Numbers: S500-00
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases