Achalasia and Dysplasia

NCT ID: NCT02010983

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Dysplasia in Longstanding Achalasia Relation Between Food Stasis and Dysplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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longstanding achalasia

Group Type EXPERIMENTAL

chromoendoscopy

Intervention Type OTHER

chromoendoscopy (lugol stain and virtual chromoendoscopy)

Interventions

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chromoendoscopy

chromoendoscopy (lugol stain and virtual chromoendoscopy)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* longstanding achalasia (\> 15y)
* \> 18y old
* informed consent

Exclusion Criteria

* allergy to iodine
* esophageal carcinoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Guy Boeckxstaens

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZleuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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an moonen, MD

Role: CONTACT

Facility Contacts

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Koen Bellens, MSc.

Role: primary

+3216341943

an moonen, MD

Role: backup

Other Identifiers

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S55021

Identifier Type: -

Identifier Source: org_study_id

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