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Endomicroscopy in Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Endomicroscopy, Chromoendoscopy, Confocal colonoscope, Surveillance colonoscopy

Eligibility Criteria

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

Inclusion Criteria:

Written informed consent must be available before any trial-related procedures
Male and female patients aged 18 years and older
Clinically and histologically verified UC
Duration or Colitis ulcerosa >8 years (date of first diagnosis)
Colitis Activity Index ≤ 8
Activity index of Truelove and Witts: mild
Ability of subject to understand character and individual consequences of clinical trial
For women with childbearing potential, adequate contraception.

Exclusion Criteria:

Known intraepithelial neoplasia or colorectal cancer
Coagulopathy (Prothrombin time <50% of control, Partial thromboplastin time >50 s)
Impaired renal function (Creatinine >1.2 mg/dL)
Pregnancy or breast feeding
Inability to obtain informed consent
Active GI Bleeding
Known allergy to methylene blue or fluorescein
Participation in other clinical trials within the last 4 weeks

Sites / Locations

Charité Campus Benjamin Franklin, Medizinische Klinik I
Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II
Johannes Gutenberg-Universität Mainz, I. Med. Klinik und Poliklinik
Ospedale Maggiore di Crema, Endoscopy and Gastroenterology Division
European Institute of Oncology, Division of Endoscopy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Chromoscopy-guided endomicroscopy with targeted biopsies

Standard endoscopy with random and targeted biopsies

Outcomes

Primary Outcome Measures

The primary objective is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of IN and to compare the proportion of patients with at least one IN

Secondary Outcome Measures

Efficacy of chromoscopy-guided endomicroscopy in the detection of lesions and in the reduction of the number of biopsies. Time needed for the examination will be measured and compared between the two groups.

Full Information

NCT ID

NCT00659867

First Posted

April 14, 2008

Last Updated

September 26, 2016

Sponsor

PENTAX Europe GmbH

Collaborators

Johannes Gutenberg University Mainz

1. Study Identification

Unique Protocol Identification Number

NCT00659867

Brief Title

Endomicroscopy in Ulcerative Colitis

Official Title

Chromoscopy-guided Endomicroscopy With the PENTAX EC-3870CIFK / EC-3870CILK Confocal Colonoscopes for the Detection of Intraepithelial Neoplasias in Subjects With Long Standing Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Why Stopped

Recruitment problems

Study Start Date

December 2008 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

PENTAX Europe GmbH

Collaborators

Johannes Gutenberg University Mainz

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. The aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy versus standard endoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Ulcerative Colitis, Endomicroscopy, Chromoendoscopy, Confocal colonoscope, Surveillance colonoscopy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

182 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Chromoscopy-guided endomicroscopy with targeted biopsies

Arm Title

Arm Type

Active Comparator

Arm Description

Standard endoscopy with random and targeted biopsies

Intervention Type

Device

Intervention Name(s)

PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes

Other Intervention Name(s)

Endomicroscope

Intervention Description

chromoscopy-guided endomicroscopy with targeted biopsies

Intervention Type

Device

Intervention Name(s)

PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes

Other Intervention Name(s)

Endomicroscope

Intervention Description

Standard endoscopy with random and targeted biopsies

Primary Outcome Measure Information:

Title

Time Frame

Day 1 (colonoscopy)

Secondary Outcome Measure Information:

Title

Time Frame

Day 1 (colonoscopy)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent must be available before any trial-related procedures Male and female patients aged 18 years and older Clinically and histologically verified UC Duration or Colitis ulcerosa >8 years (date of first diagnosis) Colitis Activity Index ≤ 8 Activity index of Truelove and Witts: mild Ability of subject to understand character and individual consequences of clinical trial For women with childbearing potential, adequate contraception. Exclusion Criteria: Known intraepithelial neoplasia or colorectal cancer Coagulopathy (Prothrombin time <50% of control, Partial thromboplastin time >50 s) Impaired renal function (Creatinine >1.2 mg/dL) Pregnancy or breast feeding Inability to obtain informed consent Active GI Bleeding Known allergy to methylene blue or fluorescein Participation in other clinical trials within the last 4 weeks

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralf Kiesslich, Prof. Dr.

Organizational Affiliation

Johannes Gutenberg-Universität Mainz, I. Med. Klinik

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charité Campus Benjamin Franklin, Medizinische Klinik I

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Johannes Gutenberg-Universität Mainz, I. Med. Klinik und Poliklinik

City

Mainz

ZIP/Postal Code

55101

Country

Germany

Facility Name

Ospedale Maggiore di Crema, Endoscopy and Gastroenterology Division

City

Crema

ZIP/Postal Code

26013

Country

Italy

Facility Name

European Institute of Oncology, Division of Endoscopy

City

Milano

ZIP/Postal Code

20141

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

18192453

Citation

Hurlstone DP, Kiesslich R, Thomson M, Atkinson R, Cross SS. Confocal chromoscopic endomicroscopy is superior to chromoscopy alone for the detection and characterisation of intraepithelial neoplasia in chronic ulcerative colitis. Gut. 2008 Feb;57(2):196-204. doi: 10.1136/gut.2007.131359.

Results Reference

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Endomicroscopy in Ulcerative Colitis

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