Clinical trial NCT02532166: Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus
Official title: Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus. Diagnostic Value of White Light Endoscopy, Narrow Band Imaging and Chromoendoscopy for Detection of Esophageal Manifestation in Patients With Oral Lichen.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lichen Planus
Keywords: narrow band imaging
Chromoendoscopy
Lugol
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: The lichen planus is a mucocutaneous disease of unknown etiology that manifests itself with an incidence of 1-2% in 30-70% of cases either at 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. In addition, four cases have been reported with esophageal squamous cell carcinoma in patients with esophageal lichen planus.

The value of moreover increasingly established use of narrow-band imaging (a process for improving the detection of early cancers in the gastrointestinal tract by creating a maximum contrast between outright and altered mucosa, which could have already shown an improved detection rate of early lesions of the esophagus as well as squamous cell carcinoma), or the chromoendoscopy has means for example Lugol solution in correlation to the histopathologic findings in lichen planus), has not been investigated to date.

Also, data of the natural long-term outcome in esophageal lichen planus infestation especially in view of malignant transformation are currently not available.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Known lichen planus of the oral mucosa

Exclusion Criteria:

* Severe cardiopulmonary disease - ASA (American Society of Anaesthesiology) class \> III
* Antisecretory and nonsteroidal anti-inflammatory medication within the last month

Primary outcomes:
measure: Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus.
timeFrame: 3-5 years
Secondary outcomes:
measure: Natural long-term incidence of esophageal lichen planus in patients with known oral lichen.
timeFrame: 3-5
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Medicine
city: Laatzen
country: Germany
facility: Klinikum Agness Karll Laatzen
Study officials:
affiliation: Department of Medicine, KRH Laatzen
name: Andrea Riphaus, PD Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.