Image-Enhanced Endoscopy in the Gastrointestinal Tract

NCT04085211 | Unknown

• 1 other identifier: KCH19-069
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gastro-Intestinal Disorder; Inflammatory Bowel Diseases; Gastro Esophageal Reflux; Atrophic Gastritis; Neuroendocrine Tumors

Keywords

endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Specific image enhancement findings to predict relapse for patients with inactive inflammatory bowel disease.

  12 months

• median duration for image enhanced endoscopy procedures

  1 day

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 18 years old
• Patient has mental capacity to consent
• Requires endoscopic procedure as part of routine care

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

Department of Gastroenterology, King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Digestive System Diseases; Inflammatory Bowel Diseases; Gastroesophageal Reflux; Gastritis, Atrophic; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastritis; Stomach Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Bu'Hussain Hayee, PhD, MBBS,

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehul Patel, MBBS, BSc

CONTACT

02032996044; mehul.patel4@nhs.net

Lee Meng Choong

CONTACT

02032991591; kch-tr.IBDtrials@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: July 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

GB (1)