Endomicroscopy in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00659867
• Other study ID #: 2006-09
• 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

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

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

External Links

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