배경/목적: 내시경역행담췌관조영술(endoscopic retrograde cholangiopancreatography)에서 가이드와이어 선택은 선택적 담관 삽관의 성공과 안전성에 중요하다. 본 다기관 무작위배정 비교임상시험은 새로 개발된 가이드와이어의 유효성과 안전성이 기존 가이드와이어에 비해 비열등함을 평가하고자 하였다. 방법: 2024년 12월부터 2025년 7월까지 3개 상급종합병원 에서 ERCP를 시행받은 환자 198명을 대상으로, 시험군과 대조군에 1:1로 무작위 배정하였다. 1차 평가변수는 선택적 담관 삽관 성공률이었으며, 2차 평가변수는 삽관 시간, 어려운 삽관 발생률, 시술 관련 이상반응이었다. 결과: 총 198명(시험군 98명, 대조군 100명)이 분석에 포함 되었고, 두 군의 기저 특성은 유사하였다. 선택적 담관 삽관 성공률은 시험군 99.0%, 대조군 96.0%로 사전에 설정한 비열등성 기준을 충족하였으며(군 간 차이 3.0%p, 95% 신뢰구간 -2.2에서 8.9), 시술후 췌장염 발생률은 두 군 간 유의한 차이가 없었다(5.1% vs. 4.0%, p=0.746). 반면, 어려운 삽관은 시험군에서 더 흔하게 발생하였다(29.6% vs. 15.0%, p=0.017). 결론: 새로 개발된 가이드와이어는 선택적 담관 삽관 성공률과 이상반응 측면에서 기존 가이드와이어 대비 비열등함을 확인 하였다.

Background/Aims: Guidewire selection is critical for endoscopic retrograde cholangiopancreatography (ERCP) in pancreatobiliary diseases. Our study evaluated the noninferiority of novel guidewire compared with conventional guidewire that is widely used in clinical practice. Methods: A total of 198 patients with a native papilla undergoing ERCP at three tertiary hospitals were randomized in a 1:1 ratio to the test or control group. The primary endpoint was the selective biliary cannulation success rate. The secondary endpoints were the cannulation time, the incidence of difficult cannulation, and adverse events, including post-ERCP pancreatitis (PEP). Difficult cannulation was defined as a cannulation time of >5 minutes, more than five cannulation attempts, or at least one unintentional pancreatic duct cannulation. Results: Among 198 patients analyzed (test: 98; control: 100), baseline characteristics were comparable. Selective biliary cannulation success was 99.0% in the test group and 96.0% in the control group; the between-group difference was 3.0 percentage points (95% CI, -2.2 to 8.9), with the lower CI bound above the prespecified -11% non-inferiority margin. PEP incidence was similar between groups (5.1% vs. 4.0%, p=0.746). However, difficult cannulation occurred more frequently in the test group than in the control group (29.6% vs. 15.0%; p=0.017), and the cannulation time was longer in the test group (5.7 vs. 3.4 minutes; p=0.011). Conclusions: The novel guidewire met the prespecified non-inferiority criterion for selective biliary cannulation success compared with the conventional guidewire. Adverse event rates, including PEP, were similar between the groups. The novel guidewire was associated with a longer cannulation time.

INTRODUCTION
METHODS
    1. Study design and population
    2. Endoscopic procedures
    3. Study outcomes and definition
    4. Statistical analysis
RESULTS
    1. Baseline characteristics
    2. Procedural characteristics
    3. Technical and clinical outcomes
요 약
ORCID
AUTHOR CONTRIBUTIONS
DATA AVAILABILITY
ACKNOWLEDGMENTS
REFERENCES

• 김의주(가천대학교 의과대학 가천대길병원 소화기내과) | Eui Joo Kim (Division of Gastroenterology, Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon)
• 한영헌(가천대학교 의과대학 가천대길병원 소화기내과) | Young Heon Han (Division of Gastroenterology, Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon)
• 김연석(가천대학교 의과대학 가천대길병원 소화기내과) | Yeon Suk Kim (Division of Gastroenterology, Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon)
• 강화평(연세대학교 의과대학 세브란스병원 소화기내과) | Huapyong Kang (Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul)
• 이시영(연세대학교 의과대학 강남세브란스병원 소화기내과) | See Young Lee (Division of Gastroenterology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul)
• 장성일(연세대학교 의과대학 강남세브란스병원 소화기내과) | Sung Ill Jang (Division of Gastroenterology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul)
• 조재희(연세대학교 의과대학 강남세브란스병원 소화기내과) | Jae Hee Cho (Division of Gastroenterology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul) Corresponding author
• 이경주(한림대학교 의과대학 한림대학교 동탄성심병원 소화기내과) | Kyong Joo Lee (Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea)
• 고동희(한림대학교 의과대학 한림대학교 동탄성심병원 소화기내과) | Dong Hee Koh (Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea)
• 이진(한림대학교 의과대학 한림대학교 동탄성심병원 소화기내과) | Jin Lee (Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea)
• 박세우(한림대학교 의과대학 한림대학교 동탄성심병원 소화기내과) | Se Woo Park (Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea) Corresponding author