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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00659867
Other study ID # 2006-09
Secondary ID
Status Terminated
Phase N/A
First received April 14, 2008
Last updated September 26, 2016
Start date December 2008
Est. completion date September 2016

Study information

Verified date September 2016
Source PENTAX Europe GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 182
Est. completion date September 2016
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes
chromoscopy-guided endomicroscopy with targeted biopsies
PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes
Standard endoscopy with random and targeted biopsies

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
PENTAX Europe GmbH Johannes Gutenberg University Mainz

Countries where clinical trial is conducted

Germany,  Italy, 

References & 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. Retraction in: Gut. 2008 Nov;57(11):1634. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary 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) No
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