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Pneumatic Dilatation or Surgical Myotomy for Achalasia

Primary Purpose

Achalasia

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Pneumatic dilatation
Laparoscopic myotomy
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pneumatic dilatation

Surgical myotomy

Arm Description

Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence.

Laparoscopic myotomy and subsequent follow up.

Outcomes

Primary Outcome Measures

Treatment failures
Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.

Secondary Outcome Measures

Dysphagia scoring
Dysphagia score according to standardized, validated scoring system.
Health Related Quality of Life
Universally adopted and validated instruments are used.
Direct medical costs.
Charges for the average hospital in respective countries.

Full Information

First Posted
March 3, 2014
Last Updated
April 4, 2016
Sponsor
Karolinska University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02086669
Brief Title
Pneumatic Dilatation or Surgical Myotomy for Achalasia
Official Title
Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pneumatic dilatation
Arm Type
Experimental
Arm Description
Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence.
Arm Title
Surgical myotomy
Arm Type
Active Comparator
Arm Description
Laparoscopic myotomy and subsequent follow up.
Intervention Type
Procedure
Intervention Name(s)
Pneumatic dilatation
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic myotomy
Primary Outcome Measure Information:
Title
Treatment failures
Description
Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.
Time Frame
At least five years after intervention
Secondary Outcome Measure Information:
Title
Dysphagia scoring
Description
Dysphagia score according to standardized, validated scoring system.
Time Frame
At least five years after intervention
Title
Health Related Quality of Life
Description
Universally adopted and validated instruments are used.
Time Frame
At least five years after intervention.
Title
Direct medical costs.
Description
Charges for the average hospital in respective countries.
Time Frame
At least five years after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed achalasia Age 18-80 years Informed consent Exclusion Criteria: Previous treatment for achalasia. Stage IV achalasia. Unwillingness to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Lundell, Professor
Organizational Affiliation
Karolinska University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
41132
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25409838
Citation
Persson J, Johnsson E, Kostic S, Lundell L, Smedh U. Treatment of achalasia with laparoscopic myotomy or pneumatic dilatation: long-term results of a prospective, randomized study. World J Surg. 2015 Mar;39(3):713-20. doi: 10.1007/s00268-014-2869-4.
Results Reference
derived

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Pneumatic Dilatation or Surgical Myotomy for Achalasia

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