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

NCT ID: NCT02532166

Last Updated: 2015-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Lichen Planus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Esophageal lichen planus

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

Group Type OTHER

Esophageal lichen planus

Intervention Type OTHER

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

Interventions

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Esophageal lichen planus

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Andrea Riphaus

PD Dr. Andrea Riphaus

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Riphaus, PD Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, KRH Laatzen

Locations

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Department of Medicine

Bochum, , Germany

Site Status RECRUITING

Klinikum Agness Karll Laatzen

Laatzen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andrea Riphaus, PD MD

Role: CONTACT

0049 511 8208 ext. 2400

Pohl Michael, MF

Role: CONTACT

0049 0234 299 ext. 0

Facility Contacts

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Pohl Michael, MD

Role: primary

0049 234 299 ext. 0

Michael Steckstor, MD

Role: backup

0049 234 299 ext. 0

Andrea Riphaus, PD MD

Role: primary

0049 511 8208 ext. 2400

Pohl Michale, MD

Role: backup

0049 511 299 ext. 0

References

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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.

Reference Type BACKGROUND
PMID: 19280529 (View on PubMed)

Other Identifiers

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2011-4072

Identifier Type: -

Identifier Source: org_study_id

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