An interventional study of Endoscopy using Narrow band imaging in Sessile Serrated Adenoma/Polyps, sponsored by Soonchunhyang University Hospital. Completed. Per ClinicalTrials.gov, last updated 2018-12-03.
Sponsored by Soonchunhyang University Hospital · Not applicable, Interventional, and Treatment
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.
This study is a prospective randomized multi-center 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 suspicious SSA/P during colonoscopy.
All patients who undergo polypectomy will be enrolled, but excluded as follows; 1. poor bowel preparation according to Boston bowel preparation scale calculation, 2. inflammatory bowel disease, 3. failure of cecal insertion, 4. continuous anti-plate agents or anti-coagulation agents users.
First, the authors will inspect polyp using the arbitrary endoscopic criteria by inspection of white light endoscopy (WLE) and if that lesion is satisfied with 3 or more than 3 out of 5 categories (1. located in the right colon, 2. flat shape, 3. covered with mucus cap or debris, 4. 1 cm or larger than 1 cm in size, 5. varicose superficial vessel was seen on the surface after submucosal injection), endoscopic resection will be performed.
And then, the authors will inspect the resection margin carefully using NBI or WLE by pre-randomization before endoscopic resection. If the remnant tissue is detected, additional endoscopic resection will be performed.
ed margin as two groups (NBI inspection group and WLE inspection
And then, 4 biopsies from 4 quadrants of margin for evaluation of complete resection.
Primary end-point is comparing the rate of additional resection for remnant lesion, the SSA/P diagnosis rate of the remnant lesions after the additional resection, and the complete resection rate of the target lesion between two groups.
Secondary aim is evaluate the accuracy for SSA/P using arbitrary WLE criteria. For evaluation of the accuracy of arbitrary WLE criteria, the authors will compare the pathologic diagosis rate of SSA/P for each criterion, and calculate the sensitivity, the specificity, the positive predictive value, the negative predictive value, and the accuracy with area under curve of ROC.
The authors hypothesized complete resection rate of SSA/P as 90% in the NBI inspection group and 70% in the WLE inspection group based on previous studies including CARE study.
The sample size was calculated as 118 (each 59) patients of SSA/P. Study duration will be 2 years.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 118 is below the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →Soonchunhyang University Hospital is the lead sponsor of 61 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
The group of NBI inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed.
Other: Endoscopy using Narrow band imaging
The group of WLE inspection on resection margin for surveillance of remnant tissue of SSA/P right after the endoscopic resection. If the remnant tissue is detected using NIB inspection, additional endoscopic resection should be performed.
Inspection of resection margin of SSA/P for the evaluation of complete resection or the presence of remnant lesion using NBI method
the detection rate of remnant lesion,
Comparing the detection rate of remnant SSA/P right after the endoscopic resection
Time frame: 2 years after IRB
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.
Time frame: 2 years after IRB
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
Time frame: 2 years after IRB
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.
Time frame: 2 years after IRB
No study locations are listed for this record.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Soonchunhyang University Hospital