Image-Enhanced Endoscopy in the Gastrointestinal Tract

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

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

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases; Gastro Esophageal Reflux; Neuroendocrine Tumors; Atrophic Gastritis; Gastro-Intestinal Disorder

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • Department of Gastroenterology, King's College Hospital
    • Contact: Mehul Patel, MBBS; Phone Number: 02032996044

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from a hospital setting, predominantly an outpatient setting where an endoscopic procedure is required part of routine care.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Inflammatory Bowel Disease; Patients with an established diagnosis of ulcerative colitis or Crohn's Disease who require either a flexible sigmoidoscopy or colonoscopy as part of routine care (e.g. surveillance or staging disease activity)
Patients with symptoms of gastro-oesophageal reflux disease; Patients with symptoms of gastro-oesophageal reflux disease requiring a gastroscopy as part of routine clinical care.
Atrophic gastritis; Patients with known or suspected atrophic gastritis that require a gastroscopy to either confirm the diagnosis or surveillance for pre-cancerous changes.
Neuroendocrine Tumours; Patients with an established history of gastric neuroendocrine tumours requiring surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Bu'Hussain Hayee, PhD, MBBS,, King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 27, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: endoscopy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Stomach Diseases; Gastroenteritis; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastritis; Inflammatory Bowel Diseases; Gastroesophageal Reflux; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Neuroendocrine Tumors; Gastritis, Atrophic
• Other Study ID Numbers: KCH19-069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No