NCT02086669

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
Last Updated

April 5, 2016

Status Verified

April 1, 2016

Enrollment Period

9 years

First QC Date

March 3, 2014

Last Update Submit

April 4, 2016

Conditions

Achalasia

Outcome Measures

Primary Outcomes (1)

  • Treatment failures

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

    At least five years after intervention

Secondary Outcomes (3)

  • Dysphagia scoring

    At least five years after intervention

  • Health Related Quality of Life

    At least five years after intervention.

  • Direct medical costs.

    At least five years after intervention.

Study Arms (2)

Pneumatic dilatation

EXPERIMENTAL

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

Procedure: Pneumatic dilatation

Surgical myotomy

ACTIVE COMPARATOR

Laparoscopic myotomy and subsequent follow up.

Procedure: Laparoscopic myotomy

Interventions

Pneumatic dilatationPROCEDURE
Pneumatic dilatation
Laparoscopic myotomyPROCEDURE
Surgical myotomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41132, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 25409838DERIVED

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Heller Myotomy

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeSphincterotomyMyotomy

Study Officials

  • Lars Lundell, Professor

    Karolinska University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 13, 2014

Study Start

January 1, 2000

Primary Completion

January 1, 2009

Study Completion

January 1, 2014

Last Updated

April 5, 2016

Record last verified: 2016-04

Locations

SE(1)