NCT02010983

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2016

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

February 14, 2013

Last Update Submit

March 19, 2026

Conditions

Relation Between Food Stasis and DysplasiaDysplasia in Longstanding Achalasia

Outcome Measures

Primary Outcomes (1)

  • incidence of dysplasia in patients with longstanding achalasia

    1 year

Secondary Outcomes (2)

  • additive value of chromoendoscopy in comparison with lugol stain

    1 year

  • relationship between food stasis and dysplasia

    1 year

Study Arms (1)

longstanding achalasia

EXPERIMENTAL
Other: chromoendoscopy

Interventions

chromoendoscopyOTHER

chromoendoscopy (lugol stain and virtual chromoendoscopy)

longstanding achalasia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • allergy to iodine
  • esophageal carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZleuven

Leuven, 3000, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 14, 2013

First Posted

December 13, 2013

Study Start

October 1, 2013

Primary Completion

December 19, 2016

Study Completion

December 19, 2016

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

BE(1)