Achalasia and Dysplasia

Not Applicable

Recruiting

• Conditions: Relation Between Food Stasis and Dysplasia; Dysplasia in Longstanding Achalasia

• Registration Number: NCT02010983
• Lead Sponsor: KU Leuven

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-14
• Study Start: 2013-10
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• allergy to iodine
• esophageal carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
incidence of dysplasia in patients with longstanding achalasia	1 year

Secondary Outcome Measures

Name	Time	Method
relationship between food stasis and dysplasia	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
additive value of chromoendoscopy in comparison with lugol stain	1 year

Trial Locations

Locations (1)

UZleuven; 🇧🇪 Leuven, Belgium