로봇 보조 수술 - 식도

Abstract

평가 배경 로봇 보조 수술은 컴퓨터가 제공하는 3차원 영상을 바탕으로 집도의가 로봇 팔을 원격조정하여 수술을 시행하는 기술이다. 2005년 식품의약품안전처에서 허가된 후 2006년 의료행위전문평가위원회에서 관혈적 수술 대비 재원기간을 단축시키고 수술부위 상처를 적게 하는 등의 장점은 있으나 비용-효과성 등 경제성이 불분명한 점을 들어 비급여로 결정된 바 있다. 이후 지속적으로 로봇 보조 수술의 급여화와 관련한 논의가 있었으며 2022년 건강보험심사평가원(‘심평원’) 예비급여부에서는 로봇 보조 수술에 대한 급여 적용 타당성 판단 등 비급여의 급여 추진과 관련하여 의사결정에 필요한 근거자료를 도출하기 위하여 해당 행위의 재평가를 본원에 의뢰하였다(예비급여부-6, 2022.01.05.). 심평원에서는 관련 학회의견을 참조하여 기존 수술(복강경 포함) 대비 임상적 유용성이 유사하거나 높은 로봇 보조 수술 및 관련 적응증 54건(11개 영역)에 대하여 평가를 의뢰하였으며 2022년 제2차 의료기술재평가위원회(2022.2.18.)에서 재평가계획서 및 소위원회 구성안에 대한 심의 후 재평가를 수행하였다. 본 평가의 목적은 로봇 보조 수술의 임상적 안전성 및 효과성에 대한 과학적 근거를 제공함으로써 관련 정책적 의사결정을 지원하는 것이며, 본 보고서는 ‘식도종양’, ‘식도열공탈장’, ‘식도게실’ 환자에서 로봇 보조 수술이 임상적으로 안전하고 효과적인지 평가하였다.

평가 방법 로봇 보조 수술의 안전성 및 효과성 평가를 위해 체계적 문헌고찰을 수행하였다. 모든 평가방법은 평가 목적을 고려하여 “로봇 보조 수술 평가 소위원회(이하 ‘소위원회’라 한다)”의 심의를 거쳐 확정하였다. 소위원회 구성은 비뇨의학과 3인, 산부인과 3인, 흉부외과 2인, 이비인후과 2인, 외과 1인, 내분비외과 1인, 근거기반의학 2인의 전문가 14인으로 구성하였다. 소위원회에서는 심평원에서 의뢰한 54건의 로봇 보조 수술에 대하여 질환에 따라 33개 항목으로 재분류하고 재평가를 수행하기로 하였다. 본 보고서는 식도영역을 대상으로 평가하였으며, 식도 영역 평가의 핵심질문은 “식도종양에서 로봇 보조 수술은 기존 수술 대비 임상적으로 안전하고 효과적인가?”, “식도열공탈장에서 로봇 보조 수술은 기존 수술 대비 임상적으로 안전하고 효과적인가?”, “식도게실에서 로봇 보조 수술은 기존 수술 대비 임상적으로 안전하고 효과적인가?”이었다. 안전성 지표는 합병증, 개흉(복) 수술 전환이었고, 효과성은 생존율, 수술시간, 출혈량, 재원기간, 삶의 질을 평가하였다. 또한 본 평가의 목적을 고려하여 연구유형은 무작위배정비교임상시험(Ranodmized controlled trial, RCT)로 제한하였다. 체계적 문헌고찰은 핵심질문을 토대로 국외 3개, 국내 5개 데이터베이스에서 검색하였으며, 문헌 선정과정은 문헌선택 및 배제기준에 따라 6명의 평가자가 짝을 이루어 독립적으로 수행하고, 의견의 불일치가 있는 경우에는 평가자간 합의를 통해 최종 논문을 결정하였다. 문헌의 비뚤림위험 평가는 Cochrane의 Risk of Bias (RoB) 도구를 사용하여 평가하였으며, 최종 선택된 문헌을 대상으로 2명의 평가자가 독립적으로 평가 하였으며, 의견이 불일치한 경우 평가자간 합의를 통해 일치된 결과를 도출하였다. 모든 자료는 연구단위로 추출하였다. 자료분석은 비교중재의 유형에 따라 구분하여 수행하였으며 정량적 분석이 가능할 경우 메타분석을 수행하고 불가능한 경우 질적 검토를 수행하였다. 체계적 문헌고찰 결과의 근거 수준은 Grading of Recommendations Assessment, Development and Evaluation (GRADE) 방법론을 이용하여 평가하였으며 본 평가는 소위원회의 검토의견을 고려하여 의료기술재평가위원회에서 최종심의 후 권고등급을 제시하였다.

평가 결과 1. 식도종양 식도종양에서 로봇 보조 수술에 대한 체계적 문헌고찰을 수행한 결과, 최종 선택된 무작위배정비교임상시험(Randomized controlled trial, RCT) 연구는 총 2개 연구(3편)였다. 이 중 개흉(복) 수술과 비교한 연구는 1개(2편)였고, 최소침습수술과 비교한 연구는 1개(1편)였다. 선택 연구는 모두 식도종양에서 식도절제술을 시행한 연구로 임상에서는 참고로 식도종양을 대상으로 악성과 양성의 구분없이 ‘근치수술’, ‘단순식도절제술’, ‘식도우회재건술’, ‘식도절제후재건술’을 같이 시행한다는 소위원회 의견이 있었다. 대상자와 연구자의 눈가림에서는 2개 연구 모두 눈가림을 시행할 수 없었다고 언급하여 비뚤림 위험이 높음으로 평가하였다. 결과 측정의 눈가림에서는 수술이라는 중재법의 특성상 연구자, 참여자의 눈가림이 불가한 부분이 있었으나 재원기간, 수술시간 등의 객관적 지표에는 눈가림 여부가 결과에 영향을 미치지 않았을 것으로 판단하여 비뚤림위험이 낮음으로 평가하였고, 설문조사 등 주관적 판단이 반영된 주관적 지표(삶의 질, 통증정도)는 높음으로 평가하였다. 이외 비뚤림위험은 전반적으로 낮음으로 평가하였다. 안전성 안전성은 합병증과 개흉(복) 수술로 전환으로 평가하였다. 전체 합병증 중 modified Clavien-Dindo classification 등급이 2이상인 합병증은 로봇 보조 수술이 개흉(복)수술보다 더 적게 발생하였다(p=0.02). 수술 후 합병증 중 폐합병증(p=0.005)과 심혈관 합병증(p=0.006)은 로봇 보조 수술에서 개흉(복)수술보다 유의하게 더 적었다. 로봇 보조 수술에서 개흉(복) 수술로 전환된 환자수는 5.56% (3/54)이었고, 재수술이 로봇 보조 수술에서 24.07% (13/54), 개흉(복) 수술 32.37% (18/55) 발생하였다. 재수술, 중환자실 재입원, 재입원 모두에서 로봇 보조 수술과 개흉(복) 수술간 통계적으로 유의한 차이는 없었다. 최소침습수술과 비교하였을 때 전체 합병증은 로봇 보조 수술에서 48.6% (88/181), 최소침습수술에서 48.1% (74/177)가 발생하였지만 두 군간 유의한 차이는 없었다. Clavien-Dindo classification 3등급 이상 합병증 발생도 로봇 보조 수술 12.2% (22/181), 최소침습수술10.2% (18/177)로 두 군간 유의한 차이가 없었다. 개흉(복) 수술 전환도 로봇 보조 수술군에서 전체 181명 중 88명(48.6%), 최소침습수술군에서는 177명 중 74명(41.8%)이 발생하였으나 두 군간 유의한 차이가 없었다. 재입원은 로봇 보조 수술군과 최소침습수술군 모두 3명(1.7%)이 발생하여 두 군간 유의한 차이가 없었다. 효과성 식도종양에서 로봇 보조 수술의 효과성은 생존율, 수술시간, 출혈량, 재원기간, 재발, 삶의 질, 림프절 절제수, 통증정도로 평가하였다. 개흉 수술과 비교하여 수술 후 5년 전체 생존율과 무질병 생존율을 보고하였는데, 5년 전체 생존율은 로봇 보조 수술에서 41%, 개흉(복)수술에서 40%였고, 무질병 생존율은 로봇 보조 수술에서 42%, 개흉(복) 수술에서 43%였고 두 군간 유의한 차이가 없었다. 수술시간은 로봇 보조 수술(평균 349분)에서 개흉(복)수술(평균 296분)보다 유의하게 길었고(p<0.001), 출혈량은 로봇 보조 수술(중간값 400ml)이 개흉(복) 수술(중간값 568ml)보다 더 적었다(p<0.001). 재원기간은 로봇 보조 수술(중간값 14일)와 개흉(복) 수술(중간값 16일)간에 유의한 차이가 없었고, 재발도 로봇 보조 수술(56% , 28/50), 개흉(복) 수술(54%, 29/54)간에 유의한 차이는 없었다. 퇴원시점과 6주 후 삶의 질을 측정한 결과 개흉(복) 수술보다 로봇 보조 수술군에서 더 좋은 삶의 질을 보고하였다(p<0.05). 림프절 절제수는 로봇 보조 수술군(중간값 27개), 개흉(복) 수술군(중간값 25개)간에 유의한 차이가 없었다. 통증정도는 로봇 보조 수술군(평균 1.86점)에서 개흉(복) 수술(평균 2.62점)보다 유의하게 더 낮았다(p<0.001). 최소침습수술(평균 244.3 ±61.0)과 비교하여 로봇 보조 수술(평균 203.8± 51.4분)의 수술시간이 유의하게 짧았다(p<0.001). 출혈량(두 군 모두 중간값 200ml), 재원기간(두 군 모두 중간값 9일), 전체 림프절 젤제수(두군 모두 중간값 23개) 모두 두 군간 유의한 차이가 없었다.

2. 식도열공탈장 식도열공탈장환자에서 로봇 보조 식도열공탈장 적출술에 대한 안전성 및 효과성을 평가하는 체계적 문헌고찰을 수행하였으나 최종 선정된 RCT 문헌은 없었다.

3. 식도게실 식도게실에서 로봇 보조 식도게실 적출술에 대한 안전성 및 효과성을 평가하는 체계적 문헌고찰을 수행하였으나 최종 선정된 RCT 문헌은 없었다.

결론 및 제언 소위원회에서는 현재 문헌적 근거를 바탕으로 다음과 같이 결과 및 의견을 제시하였다. ⅰ) 식도종양 환자 수술에서 중요한 지표로 판단된 폐 합병증과 심혈관계 합병증 발생이 로봇 보조 수술에서 적어 개흉(복) 수술보다 더 안전하고, 최소침습수술과 차이가 없어 안전한 기술로 평가하였다. 개흉(복) 수술과 비교하였을 때 로봇 보조 수술은 생존율은 차이가 없었지만, 수술시간이 긴 반면 출혈량이 적고, 삶의 질 개선과 통증감소에 효과적이었다. 또한 최소침습수술과 비교하였을 때는 수술시간이 짧았고 재원기간, 림프절 절제수에서 차이가 없었다. 따라서 소위원회는 식도종양에서 로봇 보조 수술은 안전하고 출혈량은 기존 수술과 유사하거나 감소시키고 재원기간, 림프절 절제수는 유사하여 효과적인 기술로 평가하였다. ⅱ) 식도열공탈장 환자에서 로봇 보조 수술에 대한 RCT 문헌은 확인되지 않아, 소위원회에서는 해당 질환에서 로봇 보조 수술이 기존 수술과 비교하여 안전하고 효과적인지 판단할 수 없다고 평가하였다. 또한 향후 잘 설계된 임상연구를 기반으로 식도열공탈장에서의 로봇 보조 수술의 안전성과 효과성에 대한 근거가 필요하다고 제언하였다. ⅲ) 식도게실 환자에서 로봇 보조 수술에 대한 RCT 문헌은 확인되지 않아, 소위원회에서는 해당 질환에서 로봇 보조 수술이 기존 수술과 비교하여 안전하고 효과적인지 판단할 수 없다고 평가하였다. 또한 향후 잘 설계된 임상연구를 기반으로 식도게실환자에서의 로봇 보조 수술의 안전성과 효과성에 대한 근거가 필요하다고 제언하였다. 2022년 제12차 의료기술재평가위원회(2022.12.9.)에서는 의료기술재평가사업 관리지침 제4조 제10항에 의거 “로봇 보조 수술”에 대하여 로봇 보조 수술이 사용되는 전반적인 항목을 대상으로 문헌적 근거를 검토한 소위원회의 결론에 대하여 종합적으로 심의하였다. ⅰ) 의료기술재평가위원회는 임상적 안전성과 효과성의 근거 및 그 외 평가항목 등을 종합적으로 고려하였을 때, 국내 임상상황에서 식도종양 환자를 대상으로 수행하는 로봇 보조 수술을 ‘조건부 권고함’으로 심의하였다(권고등급: 조건부 권고함). ⅱ) 의료기술재평가위원회는 임상적 안전성과 효과성 등을 판단할 RCT 문헌을 확인하지 못하여 국내 임상상황에서 식도열공탈장 환자를 대상으로 수행하는 로봇 보조 수술의 권고등급을 결정할 수 없어 ‘불충분’으로 심의하였다(권고등급: 불충분). ⅲ) 의료기술재평가위원회는 임상적 안전성과 효과성 등을 판단할 RCT 문헌을 확인하지 못하여 국내 임상상황에서 식도게실 환자를 대상으로 수행하는 로봇 보조 수술의 권고등급을 결정할 수 없어 ‘불충분’으로 심의하였다(권고등급: 불충분).

주요어 식도암, 로봇 보조 수술, 최소침습수술

Background Robotic-assisted procedures involve a technique that allows a surgeon to remotely control a robotic arm to perform surgery based on three-dimensional images supplied by a computer. Such procedures were approved by the Ministry of Food and Drug Safety in 2005. However, in 2006, the Medical Practice Professional Assessment Committee determined that robotic-assisted surgeries were non-reimbursable items based on uncertainty regarding their economic feasibility (such as cost-effectiveness), even though these procedures offered advantages such as reducing hospital stays and minimizing surgical site wounds compared with conventional open surgery. Since then, there have been ongoing discussions regarding the reimbursement of robotic-assisted surgery. In 2022, the Preliminary Coverage Division of the Health Insurance Review and Assessment Service (HIRA) commissioned our institution to conduct a reassessment of this medical practice to derive evidence-based data needed for decision-making regarding the expansion of coverage, such as the determination of the validity of including robotic-assisted surgeries as reimbursable items (Preliminary Coverage Division; May 1, 2022). The assessment included an evaluation of the clinical usefulness of robotic-assisted surgery and related indications for 54 cases (11 domains) based on the opinions of relevant medical societies and applicable indications with similar or higher clinical usefulness as compared to the usefulness of conventional surgery (such as laparoscopic surgery). Accordingly, the reassessment was conducted after a review of the reassessment plan and the proposed subcommittee composition during the 2nd session of the Committee of Health Technology Reassessment in 2022 (February 18, 2022). The purpose of this assessment was to provide scientific evidence on the clinical safety and effectiveness of robotic-assisted surgery for supporting relevant policy decision-making. This report contains the assessment results on whether robotic-assisted surgeries are clinically safe and effective in patients with esophageal neoplasms, esophageal hiatal hernia, or esophageal diverticulum.

Methods A systematic review was performed to assess the safety and effectiveness of robotic-assisted surgery. All assessment methods were finalized after review by the “Robotic Surgical Procedure Assessment Subcommittee” (hereinafter referred to as “subcommittee”), with consideration of the purpose of the assessment. The subcommittee consisted of 14 experts: three urologists, three obstetricians and gynecologists, two thoracic surgeons, two otolaryngologists, one general surgeon, one endocrine surgeon, and two evidence-based medicine specialists. The subcommittee conducted the reassessment by reclassifying the 54 cases of robotic-assisted surgeries identified by the HIRA into 33 items according to disease type. This report contains the assessment results on the clinical safety and effectiveness of robotic-assisted surgery for patients with tumors in the esophageal region. The key questions of the assessment were as follows: “Are robotic-assisted surgeries clinically safe and effective in patients with esophageal neoplasms, as compared to conventional surgery?”; “Are robotic-assisted surgeries clinically safe and effective in patients with esophageal hiatal hernia, as compared to conventional surgery?”; and “Are robotic-assisted surgeries clinically safe and effective in patients with esophageal diverticulum, as compared to conventional surgery?.” The safety indicators included complications and conversion to thoracotomy (laparotomy), whereas the effectiveness indicators included survival rate, operating time, amount of bleeding, length of hospital stay, and quality of life (QoL). The assessment was limited to randomized controlled trials (RCTs) considering the purpose of this evaluation. For the systematic review, three international and five domestic databases were searched based on the key question. The literature selection process involved six evaluators forming pairs and independently conducting the selection process according to predefined selection and exclusion criteria. In case of any disagreement, the final articles were selected through consensus among the evaluators. Risk of bias (RoB) assessment was performed using the Cochrane Risk of Bias tool for the selected literature. Two evaluators independently assessed the selected literature, and in cases of disagreement, a consensus was reached through discussion. All data were extracted by members of the research unit. Data analysis was performed according to the type of comparator intervention. A meta-analysis was performed if quantitative analysis was possible; otherwise, a qualitative review was performed. The results of the systematic review were assessed for level of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method. The Committee of Health Technology Reassessment issued the grade of recommendation after a final review with consideration of the subcommittee’s review opinions.

Results 1. Esophageal neoplasm A total of two RCTs (three articles) were ultimately selected from a systematic review on robotic-assisted surgery for esophageal neoplasms. Of these, one RCT compared robotic-assisted surgery with thoracotomy (laparotomy), and the other RCT compared robotic-assisted surgery with minimally invasive surgery. Both the selected RCTs performed esophagectomy in patients with esophageal neoplasms; for reference, the subcommittee assumed that radical surgery, simple esophagectomy, esophageal bypass reconstruction, and esophageal reconstruction after resection were performed together in clinical practice regardless of whether the esophageal neoplasm was benign or malignant. With respect to participant-personnel blinding, the RoB was assessed to be high, as both RCTs reported that such blinding could not be applied. With respect to blinding of outcome measures, the RoB was assessed to be low based on the determination that the blinding of objective indicators (e.g., length of hospital stay, operating time) would not influence the outcome measures despite the fact that participant-personnel blinding may have been impossible in some parts due to the nature of the intervention (as the intervention was a surgery). The RoB was assessed to be high for subjective indicators (e.g., QoL, pain severity) that reflect subjective determination, such as those obtained from a questionnaire survey. The RoB for the other domains was generally assessed to be low.

Safety Safety was assessed based on complications and conversion to a thoracotomy (laparotomy). Among all the complications, modified Clavien-Dindo classification grade ≥ 2 complications were lower in robotic-assisted surgery group than in the thoracotomy (laparotomy) group (p=0.02). Among postoperative complications, pulmonary (p=0.005) and cardiovascular (p=0.006) complications were significantly lower in robotic-assisted surgery group than in the thoracotomy (laparotomy) group. In robotic-assisted surgery group, 5.56% of patients (3/54) underwent conversion to thoracotomy (laparotomy), whereas 24.07% of patients (13/54) in robotic-assisted surgery group and 32.37% of patients (18/55) in the thoracotomy (laparotomy) group underwent reoperation. However, no significant differences were noted in the reoperation, intensive care unit readmission, and hospital readmission rates between robotic-assisted surgery group and thoracotomy (laparotomy) group. The incidence of all complications was 48.6% (88/181) in robotic-assisted surgery group and 48.1% (74/177) in the minimally invasive surgery group, but no significant difference was noted between the two groups. The incidence of Clavien-Dindo classification grade ≥3 complications was 12.2% (22/181) in robotic-assisted surgery group and 10.2% (18/177) in the minimally invasive surgery group, but no significant difference was noted between the two groups. Conversion to thoracotomy (laparotomy) was found in 88 patients (48.6%) in robotic-assisted surgery group and 74 patients (41.8%) in the minimally invasive surgery group, but with no significant difference between the two groups. Moreover, no significant difference was noted in readmission rate between the two groups; readmission was observed in three patients (1.7%) each in both robotic-assisted surgery group and minimally invasive surgery group.

Effectiveness The effectiveness of robotic-assisted surgery in patients with esophageal neoplasms was assessed based on the survival rate, operating time, amount of bleeding, length of hospital stay, recurrence, QoL, number of lymph nodes removed, and pain severity. The postoperative 5-year overall survival rate and disease-free survival rate of robotic-assisted surgery were reported and compared to those of thoracotomy. The 5-year overall survival rate was 41% in robotic-assisted surgery group and 40% in the thoracotomy (laparotomy) group, whereas disease-free survival rate was 42% in robotic-assisted surgery group and 43% in the thoracotomy (laparotomy) group, with no significant difference between the two groups in this regard. The operating time was significantly longer in robotic-assisted surgery group (mean: 349 minutes) than in the thoracotomy (laparotomy) group (mean: 296 minutes; p<0.001), whereas the amount of bleeding was lower in robotic-assisted surgery group (median: 400 mL) than in the thoracotomy (laparotomy) group (median: 568 mL; p<0.001). Further, no significant difference was noted in the length of hospital stay between robotic-assisted surgery group (median: 14 days) and thoracotomy (laparotomy) group (median: 16 days). Similarly, no significant difference was noted in recurrence rate between robotic-assisted surgery group (56%, 28/50) and thoracotomy (laparotomy) group (54%, 29/54). The measurement of QoL at six weeks after discharge showed that the QoL was higher in robotic-assisted surgery group than in the thoracotomy (laparotomy) group (p<0.05). No significant difference was noted in the number of lymph nodes removed between robotic-assisted surgery group (median: 27) and thoracotomy (laparotomy) group (median: 25). Pain severity was significantly lower in robotic-assisted surgery group (mean: 1.86 points) than in the thoracotomy (laparotomy) group (mean: 2.62 points; p<0.001). The operating time was significantly shorter in robotic-assisted surgery group (mean: 203.8±51.4 minutes) than in the minimally invasive surgery group (mean: 244.3±61.0 minutes; p<0.001), whereas no significant differences were noted in the amount of bleeding (median: 200 mL in both groups), length of hospital stay (median: 9 days in both groups), and number of lymph nodes removed (median: 23 in both groups) between the two groups.

2. Esophageal hiatal hernia A systematic review was performed to assess the safety and effectiveness of robot-assisted esophageal hiatal hernia surgery in patients with esophageal hiatal hernia. However, no RCTs were identified or ultimately selected.

3. Esophageal diverticulum A systematic review was performed to assess the safety and effectiveness of robot-assisted esophageal diverticulum surgery in patients with esophageal diverticulum. However, no RCTs were identified or ultimately selected.

Conclusions and recommendation Based on the current evidence in literature, the subcommittee presented the following findings and opinions. ⅰ) In patients with esophageal neoplasms, pulmonary and cardiovascular complications, which are considered key surgery-related indicators, were lower in robotic-assisted surgery group than in the thoracotomy (laparotomy) group and were comparable with those in the minimally invasive surgery group. Compared with thoracotomy (laparotomy), robotic-assisted surgery was associated with similar survival rates and longer operating times; however, robotic-assisted surgery was found to be more effective in reducing the amount of bleeding, improving QoL, and reducing pain than thoracotomy. Compared with minimally invasive surgery, robotic-assisted surgery was associated with shorter operating times, although no significant difference was noted in the length of hospital stay and number of lymph nodes removed. Accordingly, the subcommittee determined that robotic-assisted surgery comprises a safe health technology for patients with esophageal neoplasms and that, compared with conventional surgery, robotic-assisted surgery has similar or improved effectiveness with respect to the amount of bleeding and similar effectiveness with respect to the length of hospital stay and number of lymph nodes removed. ⅱ) The subcommittee concluded that the safety and effectiveness of robotic-assisted surgery as compared to those of conventional surgery in patients with esophageal hiatal hernia could not be determined due to nonavailability of articles reporting on relevant RCTs. In addition, the subcommittee recommended that evidence on the safety and effectiveness of robotic-assisted surgery for esophageal hiatal hernia should be obtained based on well-designed clinical trials in the future. ⅲ) The subcommittee concluded that the safety and effectiveness of robotic-assisted surgery as compared to those of conventional surgery in patients with esophageal diverticulum could not be determined due to nonavailability of articles reporting on relevant RCTs. In addition, the subcommittee recommended that evidence of the safety and effectiveness of robotic-assisted surgery for esophageal diverticulum should be obtained based on well-designed clinical trials in the future. During the 12th session of the Committee of Health Technology Reassessment in 2022 (December 9, 2022), the committee comprehensively reviewed the subcommittee findings on the evidence in literature for the general domains in which robotic-assisted surgery is used in accordance with Article 4-10 of the Guidelines for Management of Health Technology Reassessment Project.

ⅰ) The Committee of Health Technology Reassessment “conditionally recommends” the use of robotic-assisted surgery in clinical practice in Korea for patients with esophageal neoplasms in consideration of the evidence of their clinical safety and effectiveness and other assessment findings (grade of recommendation: conditionally recommended). ⅱ) The Committee of Health Technology Reassessment determined that the level of evidence for robotic-assisted surgery performed in clinical practice in Korea for patients with esophageal hiatal hernia is “insufficient” due to nonavailability of RCTs reporting on their clinical safety and effectiveness (grade of recommendation: insufficient). ⅲ) The Committee of Health Technology Reassessment determined that the level of evidence for robotic-assisted surgery performed in clinical practice in Korea for patients with esophageal diverticulum is “insufficient” due to nonavailability of RCTs reporting on their clinical safety and effectiveness (grade of recommendation: insufficient).

Keywords: Esophageal neoplasms, Robotic-assisted surgery, Minimally invasive surgery