Endomicroscopy in Ulcerative Colitis

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

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.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes; Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12200
    • Charité Campus Benjamin Franklin, Medizinische Klinik I
  • Jena, Germany, 07740
    • Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II
  • Mainz, Germany, 55101
    • Johannes Gutenberg-Universität Mainz, I. Med. Klinik und Poliklinik
• Italy
  • Crema, Italy, 26013
    • Ospedale Maggiore di Crema, Endoscopy and Gastroenterology Division
  • Milano, Italy, 20141
    • European Institute of Oncology, Division of Endoscopy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Chromoscopy-guided endomicroscopy with targeted biopsies	Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes; chromoscopy-guided endomicroscopy with targeted biopsies; Other Names: Endomicroscope; Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes; Standard endoscopy with random and targeted biopsies; Other Names: Endomicroscope
ACTIVE_COMPARATOR: B; Standard endoscopy with random and targeted biopsies	Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes; chromoscopy-guided endomicroscopy with targeted biopsies; Other Names: Endomicroscope; Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes; Standard endoscopy with random and targeted biopsies; Other Names: Endomicroscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: PENTAX Europe GmbH
• Collaborators: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Ralf Kiesslich, Prof. Dr., Johannes Gutenberg-Universität Mainz, I. Med. Klinik

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: April 14, 2008
• First Submitted That Met QC Criteria: April 14, 2008
• First Posted (ESTIMATE): April 16, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Chromoendoscopy; Endomicroscopy; Confocal colonoscope; Surveillance colonoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 2006-09