Incidence of Esophageal Lichen Planus in Patients With Kn... | NCT02532166

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

NCT02532166

Sponsor

Ruhr University of Bochum

Status

Unknown status

Last Update Posted

Aug 25, 2015Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Lichen Planus

Interventions

Esophageal lichen planus

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Aug 17, 2015

First Submission Date that Met QC Criteria

Aug 24, 2015

First Posted Date

Aug 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2015

Last Update Posted Date

Aug 25, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Riphaus, PD Dr. Andrea Riphaus, Ruhr University of BochumPrincipal Investigator

Lead Sponsor

Ruhr University of BochumOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Esophageal lichen planus	Other	White light endoscopy compared to narrow band imaging and chromoendoscopy with Lugol for detection of esophageal lichen.	Other: Esophageal lichen planus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esophageal lichen planus	Other	White light endoscopy compared to narrow band imaging and Lugol for detection of esophageal lichen.	Esophageal lichen planus

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea Riphaus, PD MD	Contact	0049 511 8208	2400	ariphaus@web.de
Pohl Michael, MF	Contact	0049 0234 299	0	Michael.pohl@rub.de

Overall Officials

Name	Affiliation	Role
Andrea Riphaus, PD Dr	Department of Medicine, KRH Laatzen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine	Recruiting	Bochum		44892	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19280529	Background	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.

ID	Term
D017512	Lichenoid Eruptions
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases