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

NCT02610569 | Completed

• 1 other identifier: 2013-A01674-41
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis

Keywords

Colonic capsule; ulcerative colitis; mucosal healing; endoscopic score

Outcome Measures

Primary Outcomes (1)

• Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the endoscopic MAYO score in patients with UC.

  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 Outcomes (12)

• Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the UCEIS score in patients with UC.

  Week 12

• Concordance between PillCamCOLON (C2) and conventional endoscopy for measuring the variation of Mayo scores during an anti-TNF alpha or vedolizumab treatment

  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

  Week 12

• Presence of lesions upstream of the left colonic flexure using PillCamCOLON (C2), when recto-sigmoidoscopy is the conventional endoscopic procedure used.

  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.

  Week 12

Study Arms (2)

standart endoscopy

ACTIVE COMPARATOR

Intervention: 2 standard endoscopy during anti-TNFalpha or vedolizumab treatment

Device: standard endoscopy

PillCamCOLON (C2)

EXPERIMENTAL

Intervention : 2 PillCamCOLON (C2) during anti-TNFalpha or vedolizumab treatment

Device: PillCamCOLON (C2)

Interventions

standard endoscopy DEVICE

standard endoscopy will be either colonoscopy or rectosigmoidoscopy

standart endoscopy

PillCamCOLON (C2) DEVICE

PillCamCOLON (C2) is a colon video-capsule

PillCamCOLON (C2)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Arnaud Bourreille: lead

Study Sites (1)

University Hospital of Nantes

Nantes, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Arnaud Bourreille, MD

  University Hospital of Nantes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: November 20, 2015
• Study Start: April 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2021
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

FR (1)