Achalasia and Dysplasia | NCT02010983

Studies
Achalasia and Dysplasia

NCT02010983

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Mar 20, 2026Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Dysplasia in Longstanding Achalasia
Relation Between Food Stasis and Dysplasia

Interventions

chromoendoscopy

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 19, 2016Actual

Completion Date

Dec 19, 2016Actual

First Submitted Date

Feb 14, 2013

First Submission Date that Met QC Criteria

Dec 12, 2013

First Posted Date

Dec 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2026

Last Update Posted Date

Mar 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
longstanding achalasia	Experimental		Other: chromoendoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
chromoendoscopy	Other	chromoendoscopy (lugol stain and virtual chromoendoscopy)	longstanding achalasia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of dysplasia in patients with longstanding achalasia		1 year

Secondary Outcomes

Measure	Description	Time Frame
additive value of chromoendoscopy in comparison with lugol stain		1 year
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

allergy to iodine
esophageal carcinoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided