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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Lichen Planus
• Intervention / Treatment: Other: Esophageal lichen planus

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pohl Michael, MF; Phone Number: 0049 0234 299; Email: Michael.pohl@rub.de

Study Locations

• Germany
  • Bochum, Germany, 44892
    • Recruiting
    • Department of Medicine
    • Contact: Pohl Michael, MD; Phone Number: 0049 234 299; Email: michael.pohl@rub.de
    • Contact: Michael Steckstor, MD; Phone Number: 0049 234 299; Email: miachel.steckstor@rub.de
  • Laatzen, Germany, 30880
    • Recruiting
    • Klinikum Agness Karll Laatzen
    • Contact: Pohl Michale, MD; Phone Number: 0049 511 299; Email: michael.pohl@rub.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus.	3-5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Natural long-term incidence of esophageal lichen planus in patients with known oral lichen.	3-5

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Investigators: Principal Investigator: Andrea Riphaus, PD Dr, Department of Medicine, KRH Laatzen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 25, 2015

Study Record Updates

• Last Update Posted (Estimate): August 25, 2015
• Last Update Submitted That Met QC Criteria: August 24, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: narrow band imaging; Chromoendoscopy; Lugol
• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus
• Other Study ID Numbers: 2011-4072