Sessile Serrated Adenoma/Polyps Clinical Trial
Official title:
Usefulness of Narrow Band Imaging (NBI) for Complete Endoscopic Resection of Sessile Serrated Adenoma/Polyp (SSA/P): NASA Study
Verified date | November 2018 |
Source | Soonchunhyang University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a prospective randomized study to evaluate the role of NBI for improving complete resection rate of sessile serrated adenoma/polyp (SSA/P). The authors will enroll consecutive patients who underwent colon polypectomy for SSA/P during colonoscopy. The authors will inspect resection margin of SSA/P using white light endosocpy (WLE) or NBI after randomization for the evaluation of remnant lesion. Additional resection will be performed for suspicious of remnant lesion, and then 4 biopsies from 4 quadrants of margin for evaluation of complete resection.
Status | Completed |
Enrollment | 118 |
Est. completion date | November 25, 2018 |
Est. primary completion date | November 10, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Colonoscopy examinee with suspicious SSA/P Exclusion Criteria: - Poor bowel preparation (total Boston bowel preparation scale < 6 or any region score < 2) - Inflammatory bowel disease - failed cecal insertion of colonoscopy - continuous taking anticoagulation or anti-platelet drugs until on the procedure day |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Soonchunhyang University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the detection rate of remnant lesion, | Comparing the detection rate of remnant SSA/P right after the endoscopic resection | 2 years after IRB | |
Primary | The diagnosis rate of SSA/P in the remnant tissue | Pathologic diagnosis rate of SSA/P after the additional endoscopic resection of the remnant tissue detected by NBI or WLE right after the endoscopic resection. | 2 years after IRB | |
Primary | Incomplete resection rate of SSA/P | Compare the incomplete resection rate of SSA/P using four directional biopsied on the resection margin after the endoscopic resection including additional resection | 2 years after IRB | |
Secondary | Accuracy of arbitrary endoscopic criteria for SSA/P inspection by white light endoscopy | In this study, the authors made the arbitrary endoscopic criteria for suspicion of SSA/P by inspection of WLE. | 2 years after IRB |