Prediction of Diminutive/Small Polyp Histology: Didactic vs. Computer-based Training

NCT03843567 | Unknown

• 1 other identifier: ERN_17-1370
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bowel cancer is one of the most common cancers and the best method of diagnosing it is through endoscopic examination of the bowel (colonoscopy). Pre-cursors of bowel cancer are called polyps which can be detected and removed at the time of the colonoscopy. This reduces the chance of developing bowel cancer. There are different types of polyp ranging from completely harmless to those that may develop into cancer over time. Advances in technology mean more polyps are being detected and it is possible to predict the type of polyp. Therefore there is a new strategy in endoscopy whereby when a small polyp is detected, a prediction of polyp type is made, the polyp removed and then discarded rather than sending to the laboratory, thereby reducing costs to health services. In the hands of experts, accuracies in predicting polyp type is similar to when the polyp is removed and sent to the lab for analysis. Whilst experts can do this, non-experts cannot reach these standards and there is a need for effective training. The aim of the study is to compare the effectiveness of two training methods: Didactic face-to-face training and computer-based self-learning on the ability of trainees at predicting polyp type.

Conditions

Colorectal Polyp

Keywords

Colonic polyps; Virtual chromoendoscopy; Training; Polyp characterisation

Outcome Measures

Primary Outcomes (1)

• Ability to predict colorectal polyp histology

  Accuracy of polyp prediction, sensitivity, specificity, positive predictive value and negative predictive value

  6 months

Secondary Outcomes (2)

• High confidence predictions

  6 months

• Interobserver agreement

  6 months

Study Arms (2)

Didactic Training

PLACEBO COMPARATOR

Training will be conducted in a classroom for those participants randomised to receive didactic training, with training provided via a PowerPoint (Microsoft Inc., Redmond, Washington, USA) presentation by an expert endoscopist. An endoscopist with extensive experience in optical characterisation using virtual chromoendoscopy reviewed all teaching material.

Other: Endoscopic characterisation training

Computer-based self-training

ACTIVE COMPARATOR

Participants randomised to the computer-based self-learning group will be given the same PowerPoint presentation as the didactic group and completed the training in a separate room. Participants completed training without feedback interaction.

Other: Endoscopic characterisation training

Interventions

Endoscopic characterisation training OTHER

Included in the training material is an overview of "Resect and Discard", endoscopic platforms (NBI, BLI and i-Scan), NICE classification, SIMPLE classification, BASIC classification and example still images and videos of both classifications in use. Still images will be used to ensure participants have the best opportunity to observe and learn Kudo Pit Patterns and other polyp features without movement artefact before observing videos, which are more challenging to interpret. The training will last approximately 1 hour.

Computer-based self-training; Didactic Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Training colonoscopists: gastroenterology trainee in the process of training in colonoscopy and have had some experience of colonoscopy.

You may not qualify if:

• Inability to consent to take part in the study
• Gastroenterology trainees without experience of colonoscopy

Sponsors & Collaborators

• University of Birmingham: lead
• Brigham and Women's Hospital: collaborator
• Mount Sinai Hospital, New York: collaborator
• Gunma University Graduate School of Medicine, Maebashi: collaborator
• Iwate Medical University: collaborator
• Istituto Europeo di Oncologia: collaborator
• Federico II University: collaborator
• University of Erlangen-Nürnberg: collaborator

Related Publications (26)

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MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Samuel Smith, MBChB

CONTACT

0121 3718181; s.c.l.smith@bham.ac.uk

Hollie Caulfield

CONTACT

H.K.Caulfield@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 18, 2019
• Study Start: March 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share