Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus
1 other identifier
interventional
50
1 country
2
Brief Summary
The lichen planus is a mucocutaneous disease of unknown etiology with an incidence of 1-2%, that affects in 30-70% of cases either the mucosa of the mouth, or partly in combination with infection of the skin, the oral with his known premalignant potential in up to 2-3% predisposed to the development of an oral squamous cell carcinoma.In rare cases, there is also an manifestation of the lining of the esophagus, which can then be associated with symptomatic strictures of the esophagus. The value of moreover increasingly established endoscopic imaging procedures are investigated as well as data of the natural long-term outcome in esophageal lichen planus infestation especially in view of malignant transformation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 17, 2015
CompletedFirst Posted
Study publicly available on registry
August 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 25, 2015
August 1, 2015
3.9 years
August 17, 2015
August 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus.
3-5 years
Secondary Outcomes (1)
Natural long-term incidence of esophageal lichen planus in patients with known oral lichen.
3-5
Study Arms (1)
Esophageal lichen planus
OTHERWhite light endoscopy compared to narrow band imaging and chromoendoscopy with Lugol for detection of esophageal lichen.
Interventions
White light endoscopy compared to narrow band imaging and Lugol for detection of esophageal lichen.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Known lichen planus of the oral mucosa
You may not qualify if:
- Severe cardiopulmonary disease - ASA (American Society of Anaesthesiology) class \> III
- Antisecretory and nonsteroidal anti-inflammatory medication within the last month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Medicine
Bochum, 44892, Germany
Klinikum Agness Karll Laatzen
Laatzen, 30880, Germany
Related Publications (1)
Quispel R, van Boxel OS, Schipper ME, Sigurdsson V, Canninga-van Dijk MR, Kerckhoffs A, Smout AJ, Samsom M, Schwartz MP. High prevalence of esophageal involvement in lichen planus: a study using magnification chromoendoscopy. Endoscopy. 2009 Mar;41(3):187-93. doi: 10.1055/s-0028-1119590. Epub 2009 Mar 11.
PMID: 19280529BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Riphaus, PD Dr
Department of Medicine, KRH Laatzen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. Andrea Riphaus
Study Record Dates
First Submitted
August 17, 2015
First Posted
August 25, 2015
Study Start
January 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
August 25, 2015
Record last verified: 2015-08