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OpenTrials
Completed

NCT Number: NCT02010983

Achalasia and Dysplasia

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

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Key information

Conditions

Dysplasia in Longstanding Achalasia Relation Between Food Stasis and Dysplasia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZleuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • allergy to iodine
  • esophageal carcinoma

Treatment and study plan

Chromoendoscopy

Other

chromoendoscopy (lugol stain and virtual chromoendoscopy)

Primary outcomes

  1. incidence of dysplasia in patients with longstanding achalasia

    Time frame: 1 year

Secondary outcomes

  1. additive value of chromoendoscopy in comparison with lugol stain

    Time frame: 1 year

  2. 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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

Screening for Dysplasia in Longstanding Idiopathic Achalasia: a Prospective Study

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 13, 2013
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.