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Achalasia and Dysplasia

Screening for Dysplasia in Longstanding Idiopathic Achalasia: a Prospective Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02010983
Enrollment
39
Registered
2013-12-13
Start date
2013-10-01
Completion date
2016-12-19
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysplasia in Longstanding Achalasia, Relation Between Food Stasis and Dysplasia

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

Interventions

chromoendoscopy (lugol stain and virtual chromoendoscopy)

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* allergy to iodine * esophageal carcinoma

Design outcomes

Primary

MeasureTime frame
incidence of dysplasia in patients with longstanding achalasia1 year

Secondary

MeasureTime frameDescription
additive value of chromoendoscopy in comparison with lugol stain1 year
relationship between food stasis and dysplasia1 year* relationship between elevated LES pressure and dysplasia * relationship between stasis on EndoFLIP and dysplasia * relationship between stasis on timed barium esophagogram and dysplasia

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026