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Achalasia and Dysplasia

Primary Purpose

Dysplasia in Longstanding Achalasia, Relation Between Food Stasis and Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
chromoendoscopy
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dysplasia in Longstanding Achalasia

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • allergy to iodine
  • esophageal carcinoma

Sites / Locations

  • UZleuvenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

longstanding achalasia

Arm Description

Outcomes

Primary Outcome Measures

incidence of dysplasia in patients with longstanding achalasia

Secondary Outcome Measures

additive value of chromoendoscopy in comparison with lugol stain
relationship between food stasis and dysplasia
relationship between elevated LES pressure and dysplasia relationship between stasis on EndoFLIP and dysplasia relationship between stasis on timed barium esophagogram and dysplasia

Full Information

First Posted
February 14, 2013
Last Updated
February 7, 2023
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02010983
Brief Title
Achalasia and Dysplasia
Official Title
Screening for Dysplasia in Longstanding Idiopathic Achalasia: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysplasia in Longstanding Achalasia, Relation Between Food Stasis and Dysplasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
longstanding achalasia
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
chromoendoscopy
Intervention Description
chromoendoscopy (lugol stain and virtual chromoendoscopy)
Primary Outcome Measure Information:
Title
incidence of dysplasia in patients with longstanding achalasia
Time Frame
1 year
Secondary Outcome Measure Information:
Title
additive value of chromoendoscopy in comparison with lugol stain
Time Frame
1 year
Title
relationship between food stasis and dysplasia
Description
relationship between elevated LES pressure and dysplasia relationship between stasis on EndoFLIP and dysplasia relationship between stasis on timed barium esophagogram and dysplasia
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: longstanding achalasia (> 15y) > 18y old informed consent Exclusion Criteria: allergy to iodine esophageal carcinoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
an moonen, MD
Email
an.moonen@med.kuleuven.be
Facility Information:
Facility Name
UZleuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen Bellens, MSc.
Phone
+3216341943
Email
koen.bellens@kuleuven.be
First Name & Middle Initial & Last Name & Degree
an moonen, MD
Email
an.moonen@med.kuleuven.be
First Name & Middle Initial & Last Name & Degree
Guy Boeckxstaens, MD PhD

12. IPD Sharing Statement

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Achalasia and Dysplasia

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