MASTERPIECE study

Phase 2

• Conditions: Patients who undergo colonoscopy

• Registration Number: JPRN-jRCTs072220003
• Lead Sponsor: raoka Toshio

Brief Summary

The full analysis set consisted of 139 subjects with 380 lesions. Endoscopists diagnosed colorectal lesions with white light, non-magnified BLI, and magnified BLI, and endoscopic resection was performed after AI diagnosis. The sensitivity, specificity, and accuracy were evaluated using the histopathology results as the gold standard; the accuracy for AI diagnosis with magnified BLI was 88.7%, which is similar to previous reports.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-20
• Study Completion: 2023-03-31
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1.Patients between 20 and 85 years old at the time of registration who undergo colonoscopy

2.Patients who undergo colonoscopy (patients who meet any of the following conditions)

-Positive fecal occult blood

-Patients who need to undergo surveillance colonoscopy after polypectomy for colorectal polyp (including mucosal resection and submucosal dissection for early stage cancer)

-Patients who have gastrointestinal symptoms such as abdominal pain, diarrhea or constipation

-Patients who need to undergo screening colonoscopy for colorectal cancer

-Patients who are recommended to undergo colonoscopy by their physician

3.Patients who can understand the content forms, those who can make a decision by themselves and those who can give written consent

Exclusion Criteria

1.Patients with inflammatory bowel disease

2.Patients with familial adenomatous polyposis

3.Patients with a history of colorectal resection except appendicectomy

4.Patients with colorectal stenosis

5.Pregnant patients

6.Patients with abnormal blood coagulation function

7.Patients who cannot be managed with anticoagulant and/or antiplatelet agents according to the guidelines published by Japan Gastroenterological Endoscopy Society

8.Patients with severe organ failure

9.Patients who are not suitable for enrollment in the present study judged by their physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of endoscopic diagnosis with AI

Secondary Outcome Measures

Name	Time	Method
1.Sensitivity and specificity of endoscopic diagnosis with AI<br><br>2.Accuracy, sensitivity and specificity of endoscopic diagnosis made by endoscopists<br><br>3.Differences of accuracy, sensitivity and specificity of endoscopic diagnosis between trainees and experts of colonoscopy<br><br>4.Differences of accuracy, sensitivity and specificity of endoscopic diagnosis by characteristics of lesions (size, morphology and location of lesions) between endoscopists and AI <br><br>5.Differences of endoscopists confidence level on endoscopic diagnosis between diagnosing with AI and without AI<br><br>6.Rates of adverse events (perforation or postoperative bleeding, etc.)