NCT00659867

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

6.6 years

First QC Date

April 14, 2008

Last Update Submit

September 26, 2016

Conditions

Ulcerative Colitis

Keywords

Ulcerative ColitisEndomicroscopyChromoendoscopyConfocal colonoscopeSurveillance colonoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 1 (colonoscopy)

Secondary Outcomes (1)

  • 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.

    Day 1 (colonoscopy)

Study Arms (2)

A

EXPERIMENTAL

Chromoscopy-guided endomicroscopy with targeted biopsies

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

B

ACTIVE COMPARATOR

Standard endoscopy with random and targeted biopsies

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

Interventions

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

chromoscopy-guided endomicroscopy with targeted biopsies

Also known as: Endomicroscope
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Charité Campus Benjamin Franklin, Medizinische Klinik I

Berlin, 12200, Germany

Location

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

Jena, 07740, Germany

Location

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

Mainz, 55101, Germany

Location

Ospedale Maggiore di Crema, Endoscopy and Gastroenterology Division

Crema, 26013, Italy

Location

European Institute of Oncology, Division of Endoscopy

Milan, 20141, Italy

Location

Related Publications (1)

  • 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.

    PMID: 18192453BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Ralf Kiesslich, Prof. Dr.

    Johannes Gutenberg-Universität Mainz, I. Med. Klinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trial Coordinator

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 16, 2008

Study Start

December 1, 2008

Primary Completion

July 1, 2015

Study Completion

September 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

DE(3)IT(2)