I-Scan a Novel Endoscopic Tool for the Macroscopic Identification of Mucosal Lesions

NCT ID: NCT03298776

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 758 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-26
• Study Completion Date: 2019-01-05

Brief Summary

The use of endoscopy for the diagnosis of gastrointestinal diseases has continued to increase in recent years.

Endoscopy provides an advantage over other noninvasive or minimally invasive procedures in that it allows both direct visualisation of the mucosa but direct and accurate sampling of abnormalities for histological examination. However standard endoscopy does have some limitations particularly with small lesions and pan mucosal changes. Some lesions may be entirely benign and require no further intervention but as a result of difficulty with accurate endoscopic characterization of lesions in many cases unnecessary biopsies or polypectomies are undertaken. Therefore any technology that can augment the use of standard endoscopy to minimise unnecessary intervention should be encouraged. IScan is a digital enhancement technique available with Pentax endoscopes. There have been other novel endoscopic advances for example, Narrow band imaging but these have not been adopted widely for a number of reasons including technical difficulties or patient tolerability. The aim of this study is to assess whether Pentax IScan technology is a reliable method of improving our recognition of macroscopic mucosal lesions compared to standard white light endoscopy

Detailed Description

All patients recruited will undergo standard endoscopy using current generation Pentax endoscopes. These endoscopes are widely used for standard endoscopic procedures. All of the endoscopes that will be used have the I-scan function which is controlled by the operator. Therefore there will be no difference between the groups randomised to I-Scan or standard endoscopy, other than a very slight difference in duration for I-scan, which the patient is unlikely to detect. We have received no funding from Pentax for the use of their endoscopes.

Following recruitment patients will be randomly allocated to receive standard white light endoscopy or standard white light endoscopy plus I-Scan using a random number generator at www.random.org with possible values of 0 or 1. Those with a 0 will receive standard endoscopy and those with a 1 will receive standard endoscopy plus I-Scan. Both arms will undergo standard endoscopic evaluation including appropriate biopsies by fully trained experienced endoscopists with Joint Advisory Group (JAG) accreditation for endoscopy. The investigators will be initially blinded to the indication for endoscopy until the I-Scan has been utilised at which point the indication will be revealed to ensure patient safety. Patients will have biopsies only by the clinical indication. No extra biopsies that would not normally be clinically justified will be taken. Following the procedure all patients will be asked to evaluate the tolerability of their test using a validated 10 point likert scale. All procedures will be recorded on an anonymised basis using a unique research identifier and subsequently reviewed by other expert endoscopists within the department to allow us to accurately assess the reliability and interobserver variability of the test. Each of the endoscopists will be fully trained in standard endoscopy and will be blinded to the indication for the procedure.

The study will be a randomised controlled trial. Given the nature of the study it is not possible to blind the investigators to the procedure type. The investigator carrying out the procedure will however be blinded to the indication for the procedure until the I-Scan has been used as this could lead to bias. The endoscopists reviewing the images will be blinded to all patient information and indications for the endoscopy throughout the study period.

Conditions

Endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

standard white light endoscopy

Patients will undergo the standard of care which is standard white light endoscopy

Group Type: ACTIVE_COMPARATOR

Standard endoscopy

Intervention Type: DIAGNOSTIC_TEST

Patients referred for standard endoscopy to receive standard of care only

Endoscopy and I-Scan

Patients will undergo standard of care endoscopy plus the I-Scan

Group Type: EXPERIMENTAL

I-Scan

Intervention Type: DEVICE

I-Scan is a digital enhancement technique. These endoscopes already have greater definition compared to many standard endoscopes but they also utilise a 'zoom' function and digital image enhancement.

Interventions

I-Scan

I-Scan is a digital enhancement technique. These endoscopes already have greater definition compared to many standard endoscopes but they also utilise a 'zoom' function and digital image enhancement.

Intervention Type: DEVICE

Standard endoscopy

Patients referred for standard endoscopy to receive standard of care only

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• All patients attending for a routine diagnostic endoscopic procedure where Pentax endoscopes are in use at the endoscopy unit at the Royal Hallamshire Hospital.

Exclusion Criteria

• Patients attending for a therapeutic endoscopic procedure.
• Patients with a known endoscopic diagnosis
• Patients with abnormal coagulation or any other contraindication to use of standard biopsy or polypectomy techniques used in routine diagnostic endoscopic procedures
• Patients who are unable to understand English or give informed consent
• Patients under the age of 16

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Sanders

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH18011

Identifier Type: -

Identifier Source: org_study_id