ERCP 후 췌장염 예방을 위한 췌장 스텐트. Lancet. 2024;403(10425)

ERCP 후 췌장염 예방을 위한 췌장 스텐트. Lancet. 2024;403(10425)

수많은 무작위 임상 시험의 자료로부터 췌장 스텐트 삽입이 모든 중증도의 ERCP 후 췌장염 위험을 감소시켰다는 것을 나타냈습니다. ERCP를 시행하는 고위험 환자 2595명을 포함한 17개 시험의 메타 분석에서, 췌장 스텐트는 스텐트 없는 경우에 비해 ERCP 후 췌장염의 전반적인 위험을 65 퍼센트 감소시켰습니다 (8 versus 19 percent; OR 0.35, 95% CI 0.26-0.46). 췌장 스텐트 삽입은 또한 moderately severe pancreatitis의 위험을 낮추었으며 (OR 0.38, 95% CI 0.23-0.63), severe pancreatitis의 위험도 낮추었습니다 (OR 0.20, 95% CI 0.06-0.65). Post-ERCP pancreatitis의 고위험 환자 1950명을 포함한 후속 시험에서, 췌장 스텐트 삽입과 인도메타신의 병행 사용은 인도메타신 단독 사용에 비해 post-ERCP pancreatitis의 발생률이 낮았습니다 (11.3 versus 14.9 percent; risk difference 3.6 percent, 95% CI 0.6-6.6). 중증 부작용 발생률은 그룹 간에 유의미한 차이가 없었습니다. Pancreatic stenting,의 이점을 지지하는 여러 가이드라인과 데이터에도 불구하고, 일부 연구는 예방적 목적으로 스텐트 삽입 사용이 시간이 지남에 따라 감소하는 반면 post-ERCP pancreatitis의 발생률, 중증도 및 사망률이 증가하고 있다고 제안했습니다.

 

Summary

Background

The combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention.

​

Methods

In this randomised, non-inferiority trial conducted at 20 referral centres in the USA and Canada, patients (aged ≥18 years) at high risk for post-ERCP pancreatitis were randomly assigned (1:1) to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent. Patients, treating clinicians, and outcomes assessors were masked to study group assignment. The primary outcome was post-ERCP pancreatitis. To declare non-inferiority, the upper bound of the two-sided 95% CI for the difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) would have to be less than 5% (non-inferiority margin) in both the intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov (NCT02476279), and is complete.

​

Findings

Between Sept 17, 2015, and Jan 25, 2023, a total of 1950 patients were randomly assigned. Post-ERCP pancreatitis occurred in 145 (14·9%) of 975 patients in the indomethacin alone group and in 110 (11·3%) of 975 in the indomethacin plus stent group (risk difference 3·6%; 95% CI 0·6–6·6; p=0·18 for non-inferiority). A post-hoc intention-to-treat analysis of the risk difference between groups showed that indomethacin alone was inferior to the combination of indomethacin plus prophylactic stent (p=0·011). The relative benefit of stent placement was generally consistent across study subgroups but appeared more prominent among patients at highest risk for pancreatitis. Safety outcomes (serious adverse events, intensive care unit admission, and hospital length of stay) did not differ between groups.

​

Interpretation

For preventing post-ERCP pancreatitis in high-risk patients, a strategy of indomethacin alone was not as effective as a strategy of indomethacin plus prophylactic pancreatic stent placement. These results support prophylactic pancreatic stent placement in addition to rectal indomethacin administration in high-risk patients, in accordance with clinical practice guidelines.

​

Funding

US National Institutes of Health.

​

Ref. UpTpDate 2024.03.10