Dysplasia in Longstanding AchalasiaNCT02010983
Achalasia and Dysplasia
A study testing chromoendoscopy in people with Dysplasia in Longstanding Achalasia and Relation Between Food Stasis and Dysplasia, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysplasia in Longstanding Achalasia, Relation Between Food Stasis and Dysplasia
- What is being tested?
- chromoendoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2013to 19 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- longstanding achalasia (> 15y)
- > 18y old
- informed consent
Who cannot join
- allergy to iodine
- esophageal carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Dysplasia in Longstanding Idiopathic Achalasia: a Prospective Study
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
- Being tested
- chromoendoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chromoendoscopyOther
chromoendoscopy (lugol stain and virtual chromoendoscopy)
| Study group | Role | What they receive |
|---|---|---|
| longstanding achalasia | Experimental | Not described Receives: Other: chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of dysplasia in patients with longstanding achalasia
Measured: 1 year
Secondary outcomes (2)
additive value of chromoendoscopy in comparison with lugol stain
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startOct 2013
- Primary completion19 Dec 2016
- Study completion19 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysplasia in Longstanding AchalasiaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Boeckxstaens, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010983
- Sponsor's protocol ID
- S55021
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2013
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Dysplasia in Longstanding Idiopathic Achalasia: a Prospective Study
- ClinicalTrials.gov ID
- NCT02010983
- Acronym / sponsor ID
- S55021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 19 Dec 2016 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| longstanding achalasia | Experimental | Other: chromoendoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- longstanding achalasia (> 15y)
- > 18y old
- informed consent
Key exclusion criteria (2 listed)
- allergy to iodine
- esophageal carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chromoendoscopychromoendoscopy (lugol stain and virtual chromoendoscopy) | Other | longstanding achalasia |
Primary outcome
incidence of dysplasia in patients with longstanding achalasia
Time frame: 1 year
2 secondary outcomes
additive value of chromoendoscopy in comparison with lugol stain
Time frame: 1 year
relationship between food stasis and dysplasia
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chromoendoscopy in people with Dysplasia in Longstanding Achalasia and Relation Between Food Stasis and Dysplasia, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of dysplasia in patients with longstanding achalasia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.