Comparison of PillCamCOLON (C2) Capsule and Standard Endoscopy for the Evaluation of Patients With Ulcerative Colitis (VCC2-RCH)

October 12, 2016 updated by: Dr. Arnaud Bourreille

Comparison of the PillCamCOLON (C2) Capsule With Standard Endoscopy for the Evaluation of the Severity and the Endoscopic Healing of Patients With Ulcerative Colitis (UC)

Ulcerative colitis (UC) is an inflammatory bowel disease progressing through flare-ups. The therapeutic objective, which was originally based on clinical remission, is currently evolving with the development of biotherapies towards the achievement of endoscopic remission. Current recommendations for therapeutic management advocate the achievement of endoscopic mucosal healing (EMH), with an observed decrease in the necessity for colectomy in the case of EMH. Endoscopic evaluation of the severity of UC is performed during a digestive endoscopy (colonoscopy for a complete colonic exploration, or recto-sigmoidoscopy for a partial exploration of the colon) from endoscopic activity scores adapted for UC.

Currently, the score the most commonly used is the MAYO endoscopic score. This is a global score of increasing intensity from 0 to 3, taking into account the following basic lesions: vascular pattern, granularity or/and friability of the mucosa, spontaneous bleeding, erosion and ulceration. However this score has limits: it does not distinguish deep cavitating ulcerations with mucous detachment from simple ulcerations which have a better prognosis.

A new endoscopic score specific for UC has been developed and is currently being validated. It is termed Ulcerative Colitis Endoscopic Index of Severity (UCEIS). This evaluation takes into account the three most reproducible factors - the vascular pattern, the presence of bleeding, and erosions or ulcerations including cavitating ulceration - in the total score.

To ensure optimal patient care and an adaptation of the therapeutic medical care to the endoscopic severity of the disease, endoscopic exploration should be performed recurrently. However, this exploration is an invasive procedure, requires general anaesthesia for colonoscopy, and can lead to potential complications such as perforation. This explains the poor acceptance by patients, resulting in a sub-optimal therapeutic support.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

For each patient, the study will be conducted in accordance with the following schedule:

Information/inclusion visit: D-30 (± 30 days)

  • Full information about the trial
  • Verification of inclusion and non-inclusion criteria
  • Acquisition of informed consent (either the same day or after a period of reflexion)
  • Medical and surgical history
  • Clinical examination

Endoscopic visit: D0 On two consecutive days or within a maximum of seven days but obligatorily before the anti-Tumor Necrosis Factor (TNF) alpha treatment

  • Faecal sample (calprotectin)
  • Clinical examination

  • Endoscopic examination by PillCamCOLON (C2) then by conventional endoscopy (colonoscopy)

    -The endoscopic examinations will each be analyzed by a different endoscopist working in a blinded evaluation. An UC activity score will be calculated depending on two scores: MAYO and UCEIS.

  • Notification of Adverse Event (AE) / Serious Adverse Event (SAE)

Follow-up visit: W12 (12 weeks ± 5 days after D0)

  • Faecal sample (calprotectin)
  • Clinical examination

  • Endoscopic examination by PillCamCOLON (C2) then by conventional endoscopy (coloscopy)

    -The endoscopic examinations will each be analyzed by a different endoscopist working in a blinded evaluation. An UC activity score will be evaluated depending on two scores: MAYO and UCEIS.

  • Notification of AE/SAE

End-of-study visit (possibly by telephone) W14 (± 5 days)

*Notification of AE/SAE

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patient between 18 and 70 years old
  • Patient with UC requiring treatment with anti-TNFalpha or vedolizumab
  • Patient affiliated to a social security scheme
  • Patient able to understand and follow the study instructions
  • Patient having signed an informed consent form

Exclusion Criteria:

  • Patient with severe and acute colitis
  • Patient with Crohn's disease or non-classified colitis
  • Patient with an indication for surgical management of UC
  • Patient with a history of sub-total or total colectomy, or with colostomy or ileostomy.
  • Patient with a history of intestinal irradiation
  • Patient with a known or suspected intestinal stricture
  • Patient with clinical signs suggestive of intestinal stricture
  • Patient with dysphagia with choking on solid food or swallowing disorders
  • Patient with a contra-indication for an anti TNFalpha treatment
  • Patient with a contra-indication for conventional endoscopy (colonoscopy or recto-sigmoidoscopy)
  • Patient with congestive heart failure or severe renal impairment
  • Patient with a pacemaker or other implanted electronic medical device
  • Patient participating in another interventional clinical trial
  • Pregnant or nursing woman
  • Vulnerable individuals: persons deprived of liberty, under tutelage or guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standart endoscopy
Intervention: 2 standard endoscopy during anti-TNFalpha or vedolizumab treatment
Device: standard endoscopy
standard endoscopy will be either colonoscopy or rectosigmoidoscopy
Experimental: PillCamCOLON (C2)
Intervention : 2 PillCamCOLON (C2) during anti-TNFalpha or vedolizumab treatment
Device: PillCamCOLON (C2)
PillCamCOLON (C2) is a colon video-capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the endoscopic MAYO score in patients with UC.
Time Frame: week 12 (W12)
MAYO endoscopic score established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colonic segment explored at week 12 (W12).
week 12 (W12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the UCEIS score in patients with UC.
Time Frame: Week 12
UCEIS endoscopic score established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colonic segment explored at D0 and W12.
Week 12
Concordance between PillCamCOLON (C2) and conventional endoscopy for measuring the variation of Mayo scores during an anti-TNF alpha or vedolizumab treatment
Time Frame: Week 12
Mayo endoscopic scores established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colic segment explored at D0 versus W12
Week 12
Concordance between PillCamCOLON (C2) and conventional endoscopy for measuring the variation of the UCEIS scores during an anti-TNF alpha or vedolizumab treatment
Time Frame: Week 12
UCEIS endoscopic scores established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colic segment explored at W12
Week 12
Presence of lesions upstream of the left colonic flexure using PillCamCOLON (C2), when recto-sigmoidoscopy is the conventional endoscopic procedure used.
Time Frame: Week 12
Description of lesions located upstream of the left colonic flexure in terms of their localization and severity (in particular, ulcerations) visualized by PillCamCOLON (C2) when recto-sigmoidoscopy is the conventional endoscopic procedure used (at W12).
Week 12
Capacity of PillCamCOLON (C2) to define endoscopic mucosal healing (MAYO score 0 and 1) as compared with recto-sigmoidoscopy, during treatment with anti-TNFalpha or vedolizumab.
Time Frame: Week 12
Week 12
Correlation between calprotectin level in fecal sample and disease activity.
Time Frame: Week 12
Calprotectin levels in fetal sample
Week 12
Level of adequate colonic preparation during examinations with PillCamCOLON (C2).
Time Frame: Week 12
Measurement of the quality of colonic preparation, relative to the commonly used scale, using all PillCamCOLON (C2) films obtained.
Week 12
Reproducibility inter and intraobserver for the lesions' detection and for the severity grading by PillCamCOLON (C2)
Time Frame: Week 12
Reproducibility inter and intraobserver concerning the lesions descriptions and their severity.
Week 12
Analog visual scale (AVS) the preference of the patients and their acceptability of each of 2 examinations
Time Frame: Week 12
AVS on exams acceptability between PillCamCOLON (C2) and conventional endoscopy
Week 12
Adverse events due to PillCamCOLON (C2) and conventional endoscopy
Time Frame: Week 14
To evaluate the tolerance of these two endoscopic examination procedures. Adverse events due to PillCamCOLON (C2) and adverse events due to conventional endoscopy.
Week 14
Capacity of PillCamCOLON (C2) to define the extent of UC, as compared with colonoscopy
Time Frame: Week 12
Week 12
Percentage of complete exploration by PillCamCOLON (C2)
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Arnaud Bourreille

Investigators

  • Principal Investigator: Arnaud Bourreille, MD, University Hospital of Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

April 27, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01674-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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