폐암 냉동제거술

Abstract

평가배경 “폐암 냉동제거술”은 폐암에 대한 일차적 치료 및 재수술 치료를 목적으로, 아르곤 가스와 헬륨 가스를 냉동프로브에 삽입하여 동결/해동 주기를 통해 암조직을 파괴하는 의료기술이다. 국내에서는 신의료기술평가제도가 확립되기 이전인 2006년에 비급여로 등재되었으며, 이후 2011년 건강보험 보장성 강화 정책에 따라 급여로 전환되어 임상에서 사용하고 있다. 해당 의료기술은 행위 급여 항목 중에 과거 유관기관 수요조사에서 저가치 기술로 제기된 바 있어, 내부 모니터링을 통해 재평가 주제로 발굴하였으며, 재평가 대상선별을 위한 임상자문회의와 의료기술재평가위원회의 우선순위 심의를 거쳐 2022년 제8차 의료기술재평가위원회(‘22.8.12.)에서 재평가 대상으로 최종 선정하였다. 본 평가의 목적은 폐암 환자에서 냉동제거술의 안전성 및 효과성 등에 대한 의과학적 근거 평가를 통해 의료기술의 적정 사용 등을 지원하고자 하였다.

평가방법 폐암 냉동제거술에 대한 안전성 및 효과성 평가를 위해 체계적 문헌고찰을 수행하였다. 모든 평가방법은 평가목적을 고려하여 “냉동제거술 통합 소위원회(이하 ‘소위원회’라 한다)”의 심의를 거쳐 확정하였다. 소위원회 구성은 흉부외과 2인, 호흡기내과 1인, 종양내과 1인, 영상의학과 3인, 비뇨의학과 2인, 신장내과 1인, 근거기반의학 2인 전문가로 구성하였다. 평가의 핵심질문은 “폐암 환자에서 냉동제거술은 임상적으로 안전하고 효과적인가?”이었고 안전성은 시술관련 합병증을, 효과성은 종양학적 결과, 폐 기능, 환자 관련 결과 지표로 평가하였다. 체계적 문헌고찰은 핵심질문을 토대로 국외 3개, 국내 5개 데이터베이스에서 검색하였으며, 문헌선정 및 배제기준에 따라 두 명의 검토자가 독립적으로 선별하고 선택하였다.

평가결과 “폐암 환자에서 냉동제거술”에 대한 안전성 및 효과성을 평가하는 체계적 문헌고찰을 수행하였으나 최종 선정된 문헌은 없었다.

결론 및 제언 소위원회는 현재 문헌에 근거하여 “폐암 냉동제거술”의 안전성 및 효과성 결과를 다음과 같이 제시하였다. 폐암 환자에서 냉동제거술에 대한 체계적 문헌고찰 결과, 선택문헌이 없어 안전성 및 효과성을 판단할 수 없었다. 다만, 과거 간암 냉동제거술 평가사례(2022년 제4차 의료기술재평가위원회, 2022.4.15.)와 유사하게 각 시술 경로별 냉동제거술의 안전성과 효과성이 달라질 개연성은 크지 않을 것으로 판단하였다. 따라서, 소위원회는 경피적 냉동제거술의 근거를 냉동제거술의 안전성 및 효과성 평가 근거로 고려하여 표준적 수술이 어려운 상태의 폐암 환자에서 냉동제거술을 안전하고 효과적인 의료기술로 평가하였다. 2023년 제3차 의료기술재평가위원회(2023.3.10.)에서는 소위원회 검토 결과에 근거하여 의료기술 재평가사업 관리지침 제4조제10항에 의거 “폐암 냉동제거술”에 대해 다음과 같이 심의하였다. 의료기술재평가위원회는 임상적 안전성과 효과성의 근거 및 그 외 평가항목 등을 종합적으로 고려하였을 때, 국내 임상상황에서 표준적 수술이 어려운 상태의 폐암 환자를 대상으로 냉동제거술의 사용을 ‘조건부 권고함’으로 심의하였다.

주요어 폐암, 냉동제거술, 안전성, 효과성

Background Cryoablation of lung cancer is a health technology used to destroy cancerous tissues through freeze/thaw cycles. This process involves the use of argon or helium gas, which is inserted into a probe, and is primarily used for both the initial and repeat treatment of lung cancer. In the context of Korean healthcare, this technology was initially listed as a non-benefit item in 2006, prior to the establishment of the new health technology assessment system, cryoablation underwent a reclassification in 2011. This change, aligning with the expanded health insurance coverage policy, led to its integration into clinical practice. However, despite its clinical use, cryoablation was previously assessed as a low-value technology in a demand survey conducted among relevant organizations. It was then identified for reassessment through internal monitoring processes. Following a detailed evaluation, which included candidate screening by the Clinical Advisory Board and a priority review by the Committee of Health Technology Reassessment, cryoablation was ultimately selected for reassessment during the eighth session of the Committee of Health Technology Reassessment in 2022 (on August 12, 2022). The overarching aim of this reassessment is to provide support for the appropriate use of cryoablation in healthcare settings. This goal is grounded in the need for medical and scientific evidence that confirms the safety and effectiveness of cryoablation for patients with lung cancer.

Methods To achieve this aim, a thorough systematic review was conducted to evaluate the safety and effectiveness of cryoablation in the treatment of lung cancer. The methods for this assessment were carefully developed and finalized after extensive review by the “Integrated cryoablation subcommittee (hereafter referred to as the “Subcommittee”) was notably diverse, comprising experts from a range of relevant fields: two from thoracic surgery, one from pulmonology, one from oncology, three from radiology, two from urology, one from nephrology, and two specializing in evidence-based medicine. The central question of the assessment was, “Is cryoablation clinically safe and effective for patients with lung cancer?” The assessment of safety focused on procedure-related complications, while the evaluation of effectiveness took into account several key factors: oncologic outcomes, lung function, and patient-related outcomes. For the literature review component, a strategic and extensive search was conducted across three international and five domestic databases, all framed around the key question. The process involved two independent reviewers who screened and selected articles, adhering to the predetermined inclusion and exclusion criteria.

Results A systematic review was performed to assess the safety and effectiveness of cryoablation in patients with lung cancer, but no articles met the criteria for selection.

Conclusions and recommendations In light of the available evidence, or rather the absence thereof, the Subcommittee provided an assessment of the safety and efficacy of lung cancer cryoablation. Although a systematic review on cryoablation in patients with lung cancer was conducted, its safety and efficacy remain undetermined due to the absence of selected articles. However, it was concluded that there is no significant likelihood of variance in the safety and efficacy of cryoablation across different procedural approaches. This conclusion is consistent with previous evaluations of liver cancer cryoablation (fourth session of the Committee of Health Technology Reassessment, April 15, 2022). Consequently, the Subcommittee, considering the available evidence for percutaneous cryoablation, recognized cryoablation as a safe and effective health technology for patients with lung cancer who have conditions that make for whom standard surgery is challenging. In the third session of the Committee of Health Technology Reassessment in 2023 (on March 10, 2023), the following conclusions were drawn regarding lung cancer cryoablation, in line with Article 4-10 of the Guidelines for Management of Health Technology Reassessment. The Committee “conditionally recommends” cryoablation for patients with lung cancer who are unable to undergo standard surgery due to concomitant conditions in the Korean clinical context. This recommendation is based on a comprehensive review of the evidence regarding its clinical safety and effectiveness, among other evaluation criteria.

Keywords: Lung cancer, Cryoablation, Safety, Effectiveness