MASTERPIECE study

JRCT ID: jRCTs072220003

Registered date:20/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients who undergo colonoscopy
• Date of first enrollment: 10/05/2022
• Target sample size: 170
• Study type: Interventional
• Intervention(s): Using artificial intelligence (AI) for endoscopic diagnosis with colonoscopy

Outcome(s)

• Primary Outcome: Accuracy of endoscopic diagnosis with AI

Secondary Outcome

1.Sensitivity and specificity of endoscopic diagnosis with AI

2.Accuracy, sensitivity and specificity of endoscopic diagnosis made by endoscopists

3.Differences of accuracy, sensitivity and specificity of endoscopic diagnosis between trainees and experts of colonoscopy

4.Differences of accuracy, sensitivity and specificity of endoscopic diagnosis by characteristics of lesions (size, morphology and location of lesions) between endoscopists and AI

5.Differences of endoscopists confidence level on endoscopic diagnosis between diagnosing with AI and without AI

6.Rates of adverse events (perforation or postoperative bleeding, etc.)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Uraoka Toshio
• Source(s) of Monetary Support: Fujifilm Corporation