Achalasia and Dysplasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Katholieke Universiteit Leuven
Sponsor:
Information provided by (Responsible Party):
Guy Boeckxstaens, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT02010983
First received: February 14, 2013
Last updated: July 17, 2014
Last verified: July 2014
  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: 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 Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • incidence of dysplasia in patients with longstanding achalasia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • additive value of chromoendoscopy in comparison with lugol stain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • relationship between food stasis and dysplasia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • 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: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: longstanding achalasia Other: chromoendoscopy
chromoendoscopy (lugol stain and virtual chromoendoscopy)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • allergy to iodine
  • esophageal carcinoma
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Guy Boeckxstaens, Prof. Dr., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT02010983     History of Changes
Other Study ID Numbers: S55021
Study First Received: February 14, 2013
Last Updated: July 17, 2014
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on October 20, 2014