Korean J Gastroenterol.  2022 Jan;79(1):22-30. 10.4166/kjg.2021.147.

Comparison of Clinical Performance and Safety between Domestic New Pull-type Triple-lumen Sphincterotome and Conventional Sphincterotome: A Prospective Multicenter Trial

• Park SW
• Jang SI
• Chung MJ
• Cho JH
• Bang S

• KMID: 2525519
• DOI: http://doi.org/10.4166/kjg.2021.147

Abstract

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.

Keyword

Cholangiopancreatography; endoscopic retrograde; Sphincterotomy; endoscopic; Domestic; Sphincterotomy; endoscopic; Safety

Figure

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  Fig. 1 CleverCut3™ (Olympus, Tokyo, Japan) pull-type sphincterotome. (A) Neutral state, (B) pulled state.

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  Fig. 2 Optimos™ (Taewoong, Goyang, Korea) pull-type sphincterotome. (A) Neutral state, (B) pulled state.

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  Fig. 3 Endoscopic sphincterotomy using CleverCut3™ (Olympus, Tokyo, Japan) pull-type sphincterotome. (A) Preparing sphincterotomy to 12 o’clock direction, (B) sphincterotomy state.

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  Fig. 4 Endoscopic sphincterotomy using Optimos™ (Taewoong, Goyang, Korea) pull-type sphincterotome. (A) Preparing sphincterotomy to 12 o’clock direction, (B) sphincterotomy state.

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