Image-Enhanced Endoscopy in the Gastrointestinal Tract

Inflammatory Bowel Diseases Clinical Trial

Official title:

A Series of Prospective Observational Studies Investigating the Clinical Utility of Image-enhanced Endoscopy in the Gastrointestinal (GI) Tract

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04085211
• Other study ID #: KCH19-069
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: May 2022

Study information

• Verified date: November 2020
• Source: King's College Hospital NHS Trust
• Contact: Mehul Patel, MBBS, BSc
• Phone: 02032996044
• Email: mehul.patel4[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates a range of endoscopic image enhancement techniques for assessing conditions involving the gastrointestinal tract.

This study aims to determine:

(i) the accuracy of different techniques to diagnose or grade severity of several gastrointestinal conditions

(ii) if image-enhancement techniques could potentially replace investigations currently used in daily practice (e.g. biopsy) with a view to reduce costs and shorten the interval to initiate treatment

Description:

Endoscopic procedures are performed on a daily basis to visualise the gastrointestinal tract for diagnosis and intervention. The demand for procedures is growing, consequently increasing the number of additional investigations; for example, biopsies. Image enhancement techniques can be performed during procedures either digitally or through the use of dye. These techniques alter the qualities of the image e.g. colour, contrast and magnification. We believe these techniques have several potential benefits: (i) improve diagnostic accuracy (ii) filter appropriate selection of additional investigations to maximise diagnostic yield (iii) the potential to replace existing investigations which are costly and intricate.

Participants included in the study will have an endoscopic procedure as indicated for routine clinical care. On the day of the procedure (or before), a baseline assessment will be performed - symptom questionnaires, medical history and recording any relevant investigation results performed as part of routine care. Participants will have the endoscopic procedure as normal, with additional images and video obtained using different image enhancement techniques. Select patients will have follow-up for up to one year to determine relapse. The image enhancement technique findings will be compared to the gold standard investigation currently available as part of routine care for the condition of interest.

The study will look at a range of different image enhancement techniques: dye chromoendoscopy, blue laser imaging (BLI), linked colour imaging (LCI), narrow band imaging (NBI), image magnification and endocytoscopy. This will involve a range of gastrointestinal conditions.

Ethics Approval: favourable opinion was provided by the East Midlands - Derby research and ethics committee, reference: 19/EM/0167.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: May 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age > 18 years old

• Patient has mental capacity to consent

• Requires endoscopic procedure as part of routine care

Exclusion Criteria:

• not meeting inclusion criteria

Related Conditions & MeSH terms

• Atrophic Gastritis
• Digestive System Diseases
• Gastritis
• Gastritis, Atrophic
• Gastro Esophageal Reflux
• Gastro-Intestinal Disorder
• Gastroesophageal Reflux
• Gastrointestinal Diseases
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Neuroendocrine Tumors

Locations

Country	Name	City	State
United Kingdom	Department of Gastroenterology, King's College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity, positive predictive value of specific endoscopic image enhancement findings to diagnose or stage the severity of different gastrointestinal conditions	Identify specific features on NBI,BLI, LCI, magnification and endocytoscopy to accurately diagnose / grade severity of a range of conditions when compared to the gold standard diagnostic investigation e.g. biopsy, pH impedance testing	8 weeks
Secondary	Specific image enhancement findings to predict relapse for patients with inactive inflammatory bowel disease.	Relapse as defined by the requirement for treatment escalation, surgery, hospital admission; biochemical evidence of relapse (faecal calprotectin) or worsening inflammation on repeat endoscopy.	12 months
Secondary	median duration for image enhanced endoscopy procedures	median duration (minutes) as defined as the time interval between insertion and completed withdrawal of the endoscope	1 day