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Achalasia and Dysplasia

This study is currently recruiting participants.
Verified July 2017 by Guy Boeckxstaens, Katholieke Universiteit Leuven
Sponsor:
ClinicalTrials.gov Identifier:
NCT02010983
First Posted: December 13, 2013
Last Update Posted: July 11, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Guy Boeckxstaens, Katholieke Universiteit Leuven
  Purpose

Patient with achalasia have a 10-50 fold increased risk to develop esophageal squamous cell carcinoma (ESCC). Early diagnosis of ESCC is essential, and detection of an earlier dysplastic stage is preferred. Endoscopic detection is however difficult and often delayed. Chromoendoscopy with Lugol dye increases detection rates dysplasia and ESCC to 91-100%. The aim of this study was therefore to evaluate a screening program using chromoendoscopy with Lugol to detect dysplasia in patients with idiopathic achalasia.

A second objective is to study the relationship between foodstasis and the development op dysplasia


Condition Intervention
Dysplasia in Longstanding Achalasia Relation Between Food Stasis and Dysplasia Other: chromoendoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Screening for Dysplasia in Longstanding Idiopathic Achalasia: a Prospective Study

Resource links provided by NLM:


Further study details as provided by Guy Boeckxstaens, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • incidence of dysplasia in patients with longstanding achalasia [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • additive value of chromoendoscopy in comparison with lugol stain [ Time Frame: 1 year ]
  • relationship between food stasis and dysplasia [ Time Frame: 1 year ]
    • relationship between elevated LES pressure and dysplasia
    • relationship between stasis on EndoFLIP and dysplasia
    • relationship between stasis on timed barium esophagogram and dysplasia


Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: longstanding achalasia Other: chromoendoscopy
chromoendoscopy (lugol stain and virtual chromoendoscopy)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • longstanding achalasia (> 15y)
  • > 18y old
  • informed consent

Exclusion Criteria:

  • allergy to iodine
  • esophageal carcinoma
  Contacts and Locations
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): NCT02010983


Contacts
Contact: an moonen, MD an.moonen@med.kuleuven.be

Locations
Belgium
UZleuven Recruiting
Leuven, Belgium, 3000
Contact: an moonen, MD       an.moonen@med.kuleuven.be   
Principal Investigator: Guy Boeckxstaens, MD PhD         
Sponsors and Collaborators
Katholieke Universiteit Leuven
  More Information

Responsible Party: Guy Boeckxstaens, Prof. Dr., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT02010983     History of Changes
Other Study ID Numbers: S55021
First Submitted: February 14, 2013
First Posted: December 13, 2013
Last Update Posted: July 11, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Hyperplasia
Esophageal Achalasia
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases