Dysplasia in Longstanding Achalasia Clinical Trial
Official title:
Screening for Dysplasia in Longstanding Idiopathic Achalasia: a Prospective Study
| NCT number | NCT02010983 |
| Other study ID # | S55021 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2013 |
| Est. completion date | December 2025 |
| Verified date | February 2023 |
| Source | KU Leuven |
| Contact | an moonen, MD |
| an.moonen[@]med.kuleuven.be | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - longstanding achalasia (> 15y) - > 18y old - informed consent Exclusion Criteria: - allergy to iodine - esophageal carcinoma |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | UZleuven | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| KU Leuven |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | incidence of dysplasia in patients with longstanding achalasia | 1 year | ||
| Secondary | additive value of chromoendoscopy in comparison with lugol stain | 1 year | ||
| Secondary | 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 |
1 year |