i-Scan for the Detection of Helicobacter Pylori

May 5, 2022 updated by: Imperial College London
This study aims to assess whether iScan, an intra-endoscopic imaging technique is an accurate and reliable tool in detecting and characterising Helicobacter pylori (H pylori) and comparing this to standard endoscopic imaging with white light endoscopy (WLE), narrow band imaging (NBI) and histology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ultimate goal of endoscopy will be the 'optical biopsy' i.e. forgoing the need to take histological samples to make a diagnosis in order to reduce complication rates, cost and time. There are a number of imaging techniques which promise to improve our diagnostic rates for pathology, but there have been few comparative studies.

This is randomized controlled parallel trial in a 1:1 ratio with examination of the upper gastrointestinal tract with WLE followed by either NBI or iscan.

(Note: Prior to commencement of the study, technical issues and operational changes in our organisation forced the removal of the Pentax 'i-scan' endoscopes. Recruitment to this arm was anticipated, but was ultimately not possible.)

Patients attending the department for routine examinations for dyspepsia and abdominal pain will be randomised into 2 study arms (1WLE and NBI, and the other - WLE and iscan).

The investigator carrying out the procedure will be blinded to the indication for the procedure until a full examination with both white light endoscopy and either NBI or iscan has been used as this could lead to bias. They will determine if H pylori is present, and if so the severity of infection with WLE and again with either NBI or iscan depending on their study arm. Histopathological confirmation of H pylori and an assessment to the degree of infection will be assessed with samples taken using the updated Sydney system (5 gastric samples from different parts of the stomach).

The endoscopists reviewing the images will be blinded to all patient information and indications throughout the study period. Questionnaires will then be given to the endoscopists to determine what endoscopic features led them to their diagnosis.

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, W2 1NY
        • Imperial College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• All patients attending for a routine diagnostic endoscopic procedure at St Mary's Hospital NHS Trust for dyspepsia and abdominal pain

Exclusion Criteria:

  • Patients attending for a therapeutic endoscopic procedure e.g. variceal banding, stent insertion, balloon dilatation.
  • Patients with a known diagnosis e.g. upper gastrointestinal cancer
  • Patients previously treated with HP eradication therapy
  • Patients who had taken PPI, H2 receptor antagonists and antibiotics within 4 weeks
  • Patients with acute gastrointestinal bleeding
  • Patients who'd had previous gastric surgery
  • Patients with chronic liver disease
  • Patients with abnormal coagulation or any other contra-indication to use of standard biopsy in routine diagnostic endoscopic procedures
  • Patients who are unable or unwilling to give informed consent
  • Patients under the age of 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Narrow band imaging
Narrow band imaging function (Olympus endoscopes)
Device: narrow band imaging
narrow band imaging function is located on the head of Olympus endoscopes
Experimental: i-scan imaging
i-scan imaging (Pentax endoscopes)
Device: i-scan
i-scan function is located on the head of the Pentax endoscopes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Diagnosis of Helicobacter Pylori Using Imaging Modality
Time Frame: 1 year
The endoscopic assessment of the presence of H pylori using standard endoscopy plus NBI will be compared to histological assessment. Inter-observer variability of assessment of the presence of H pylori will be compared between endoscopic imaging techniques
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Julian Teare, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14SM2185

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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