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

Primary Purpose

Lichen Planus

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Esophageal lichen planus
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lichen Planus focused on measuring narrow band imaging, Chromoendoscopy, Lugol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of MedicineRecruiting
  • Klinikum Agness Karll LaatzenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Esophageal lichen planus

Arm Description

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

Outcomes

Primary Outcome Measures

Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus.

Secondary Outcome Measures

Natural long-term incidence of esophageal lichen planus in patients with known oral lichen.

Full Information

First Posted
August 17, 2015
Last Updated
August 24, 2015
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT02532166
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planus
Keywords
narrow band imaging, Chromoendoscopy, Lugol

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esophageal lichen planus
Arm Type
Other
Arm Description
White light endoscopy compared to narrow band imaging and chromoendoscopy with Lugol for detection of esophageal lichen.
Intervention Type
Other
Intervention Name(s)
Esophageal lichen planus
Intervention Description
White light endoscopy compared to narrow band imaging and Lugol for detection of esophageal lichen.
Primary Outcome Measure Information:
Title
Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus.
Time Frame
3-5 years
Secondary Outcome Measure Information:
Title
Natural long-term incidence of esophageal lichen planus in patients with known oral lichen.
Time Frame
3-5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Riphaus, PD MD
Phone
0049 511 8208
Ext
2400
Email
ariphaus@web.de
First Name & Middle Initial & Last Name or Official Title & Degree
Pohl Michael, MF
Phone
0049 0234 299
Ext
0
Email
Michael.pohl@rub.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Riphaus, PD Dr
Organizational Affiliation
Department of Medicine, KRH Laatzen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pohl Michael, MD
Phone
0049 234 299
Ext
0
Email
michael.pohl@rub.de
First Name & Middle Initial & Last Name & Degree
Michael Steckstor, MD
Phone
0049 234 299
Ext
0
Email
miachel.steckstor@rub.de
Facility Name
Klinikum Agness Karll Laatzen
City
Laatzen
ZIP/Postal Code
30880
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Riphaus, PD MD
Phone
0049 511 8208
Ext
2400
Email
ariphaus@web.de
First Name & Middle Initial & Last Name & Degree
Pohl Michale, MD
Phone
0049 511 299
Ext
0
Email
michael.pohl@rub.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
19280529
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.
Results Reference
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Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus

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