Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus

Not Applicable

• Conditions: Lichen Planus
• Interventions: Other: Esophageal lichen planus

• Registration Number: NCT02532166
• Lead Sponsor: Ruhr University of Bochum

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.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2015-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-24
• Last Update Submitted: 2015-08-24
• Study First Posted: 2015-08-25
• Last Update Posted: 2015-08-25
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Esophageal lichen planus	Esophageal lichen planus	White light endoscopy compared to narrow band imaging and chromoendoscopy with Lugol for detection of esophageal lichen.

Primary Outcome Measures

Name	Time	Method
Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus.	3-5 years

Secondary Outcome Measures

Name	Time	Method
Natural long-term incidence of esophageal lichen planus in patients with known oral lichen.	3-5

Trial Locations

Locations (2)

Department of Medicine; 🇩🇪 Bochum, Germany

Klinikum Agness Karll Laatzen; 🇩🇪 Laatzen, Germany