RCT: HDWL vs Virtual Chromoendoscopy in the Detection of Intraepithelial Neoplasia in Longstanding Colitis

NCT02822352 | Completed

• 1 other identifier: PHT/2016/02
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

Colitis is inflammation of the large bowel and it is often caused by conditions known as ulcerative colitis and Crohn's disease. In these conditions, the body has an exaggerated inflammatory response against the bowel - the body attacks the bowel. Patients who have had colitis affecting most of the large bowel for more than 8 years are at increased risk of cancer of the large bowel. In view of this, many national gastroenterology organisations have recommended that such patients have regular colonoscopies to detect pre-cancerous areas and even early cancer in the large bowel. Early detection of such areas, will lead to early treatment thereby reducing the risk of developing significant large bowel cancer. These regular colonoscopies are known as surveillance colonoscopies. Official international guidelines for surveillance in patients with ulcerative and Crohn's colitis advise to take 4 random samples of large bowel tissue (biopsies) every 10 centimeters and of any suspicious areas. Recent studies have shown that spraying dye such as indigo carmine (a type of food dye) helps highlight abnormal areas that could harbor pre-cancerous cells. This technique is time-consuming, and tedious. There are no set standards of what is considered a satisfactorily completed dye spray colonoscopy. The uptake of this technique in the UK has not been uniform. Therefore virtual chromoendoscopy has been studied as an alternative method to improve the detection of pre-cancerous tissue in patients with longstanding colitis.

Conditions

Ulcerative Colitis; Crohn's Colitis

Outcome Measures

Primary Outcomes (1)

• To compare the rates of neoplasia detection using virtual chromoendoscopy compared to high definition white light (HDWL) endoscopy

  14 months

Secondary Outcomes (2)

• To assess the neoplasia detection rate in targeted biopsies versus non-targeted (segmental) biopsies within each arm of the study

  14 months

• To compare the duration of time taken using each technique

  14 months

Study Arms (2)

High Definition White Light

NO INTERVENTION

Surveillance colonoscopy using High Definition White Light alone

High Definition Virtualchromoendoscopy

ACTIVE COMPARATOR

High Definition Virtualchromoendoscopy

Other: Chromoendoscopy

Interventions

Chromoendoscopy OTHER

High definition virtual chromoendoscopy

High Definition Virtualchromoendoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ulcerative Colitis or Crohn's colitis with a disease duration of \>8 years for pancolitis or \>15 years duration for left-sided colitis
• Aged 18 years and above
• Patients able to give informed consent

You may not qualify if:

• Persistent coagulopathy or platelet count \<50x1012 which may preclude mucosal biopsy
• Known colonic IN or CRC
• Fulminant colitis
• Patients who have been previously randomised and withdrawn on 2 occasions due to poor bowel preparation
• Patients who are pregnant

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Related Publications (1)

• Kandiah K, Subramaniam S, Thayalasekaran S, Chedgy FJ, Longcroft-Wheaton G, Fogg C, Brown JF, Smith SC, Iacucci M, Bhandari P. Multicentre randomised controlled trial on virtual chromoendoscopy in the detection of neoplasia during colitis surveillance high-definition colonoscopy (the VIRTUOSO trial). Gut. 2021 Sep;70(9):1684-1690. doi: 10.1136/gutjnl-2020-320980. Epub 2020 Nov 19.

  PMID: 33214162 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 4, 2016
• Study Start: August 1, 2016
• Primary Completion: March 8, 2018
• Study Completion: August 7, 2018
• Last Updated: August 26, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)