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개량형 유두괄약근절개도와 외국산 유두괄약근절개도를 이용한 내시경괄약근절개술의 유용성 및 안전성 검증을 위한 공개, 무작위, 다기관, 전향적 비교 연구

Other Titles
 Comparison of Clinical Performance and Safety between Domestic New Pull-type Triple-lumen Sphincterotome and Conventional Sphincterotome: A Prospective Multicenter Trial 
 박세우  ;  장성일  ;  정문재  ;  조재희  ;  방승민 
 Korean Journal of Gastroenterology, Vol.79(1) : 22-30, 2022-01 
Journal Title
Korean Journal of Gastroenterology
Issue Date
Cholangiopancreatography, endoscopic retrograde ; Domestic ; Safety ; Sphincterotomy, endoscopic.
Background/aims: Sphincterotomes are essential for endoscopic sphincterotomy (EST) and can also be used for cannulation in ERCP. A domestic new pull-type sphincterotome (Optimos™, Taewoong, Goyang, Korea) provides acceptable technical feasibility and safety, but there are no comparison results. Thus, this study compared the clinical performance and safety of Optimos™ sphincterotome to a conventional sphincterotome (CleverCut3™, Olympus, Tokyo, Japan) in patients who underwent ERCP.

Methods: From April 2021 to July 2021, a randomized prospective comparative study was conducted on 104 consecutive patients who underwent ERCP in three medical centers. The primary endpoint was the clinical performance and safety of sphincterotomes during ERCP.

Results: One hundred and four patients were assigned randomly to the Optimos™ group (n=51) or CleverCut3™ group (n=53). All demographic characteristics did not differ between the groups except the BMI. The technical success rate for cannulation, performance of EST, and total procedure time were similar in the two groups. The adverse events did not differ, even though two cases of post-ERCP pancreatitis occurred in CleverCut3™. On the other hand, in questionnaire analysis, CleverCut™ showed a better user's convenience (median [interquartile range] 4.0 [3.0-4.0] vs. 3.0 [3.0-4.0], p=0.013) and manipulability (median [interquartile range], 4.0 [3.0-4.0] vs. 3.0 [3.0-4.0], p=0.039) than Optimos™, even though the other profiles did not reveal any differences.

Conclusions: New domestic pull-type sphincterotome can offer comparable clinical performance and safety profiles to conventional sphincterotome, but it needs refinements to increase the user's convenience and manipulability. Further improvement and innovation will be required to advance domestic medical devices.
Files in This Item:
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Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Bang, Seungmin(방승민) ORCID logo https://orcid.org/0000-0001-5209-8351
Jang, Sung Ill(장성일) ORCID logo https://orcid.org/0000-0003-4937-6167
Chung, Moon Jae(정문재) ORCID logo https://orcid.org/0000-0002-5920-8549
Cho, Jae Hee(조재희) ORCID logo https://orcid.org/0000-0003-4174-0091
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