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

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Unknown status

CT.gov ID

NCT02532166

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lichen Planus	Other: Esophageal lichen planus	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Esophageal lichen planus White light endoscopy compared to narrow band imaging and chromoendoscopy with Lugol for detection of esophageal lichen.	Other: Esophageal lichen planus White light endoscopy compared to narrow band imaging and Lugol for detection of esophageal lichen.

Arm

Intervention/Treatment

Other: Esophageal lichen planus

White light endoscopy compared to narrow band imaging and chromoendoscopy with Lugol for detection of esophageal lichen.

Other: Esophageal lichen planus

White light endoscopy compared to narrow band imaging and Lugol for detection of esophageal lichen.

Outcome Measures

Primary Outcome Measures

Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus. [3-5 years]

Secondary Outcome Measures

Natural long-term incidence of esophageal lichen planus in patients with known oral lichen. [3-5]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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