Image-Enhanced Endoscopy in the Gastrointestinal Tract

Sponsor

King's College Hospital NHS Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT04085211

Collaborator

(none)

260

Enrollment

Location

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastro-Intestinal Disorder Inflammatory Bowel Diseases Gastro Esophageal Reflux Atrophic Gastritis Neuroendocrine Tumors

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 Design

Study Type:

Observational

Anticipated Enrollment :

260 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Sensitivity, specificity, positive predictive value of specific endoscopic image enhancement findings to diagnose or stage the severity of different gastrointestinal conditions [8 weeks]
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

Secondary Outcome Measures

Specific image enhancement findings to predict relapse for patients with inactive inflammatory bowel disease. [12 months]
Relapse as defined by the requirement for treatment escalation, surgery, hospital admission; biochemical evidence of relapse (faecal calprotectin) or worsening inflammation on repeat endoscopy.
median duration for image enhanced endoscopy procedures [1 day]
median duration (minutes) as defined as the time interval between insertion and completed withdrawal of the endoscope