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

Lichen Planus Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02532166
• Other study ID #: 2011-4072
• Status: Recruiting
• Phase: N/A
• First received: August 17, 2015
• Last updated: August 24, 2015
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: Ruhr University of Bochum
• Contact: Andrea Riphaus, PD MD
• Phone: 0049 511 8208
• Email: ariphaus[@]web.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral

Intervention

Other:
• Esophageal lichen planus
White light endoscopy compared to narrow band imaging and Lugol for detection of esophageal lichen.

Locations

Country	Name	City	State
Germany	Department of Medicine	Bochum
Germany	Klinikum Agness Karll Laatzen	Laatzen

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus.		3-5 years	No
Secondary	Natural long-term incidence of esophageal lichen planus in patients with known oral lichen.		3-5	No