Expert consensus on evaluation indicators for the application of domestic high-end thoracoscopic thoracic surgery_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

 CHEN Chang , Shanghai Medical Association Thoracic Surgery Branch , Shanghai Medical Doctor Association Thoracic Surgery Physician Branch , General Thoracic Surgery Clinical Capacity Promotion and Improvement Alliance

Department of Thoracic Surgery, Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, 200433, P. R. China;

Corresponding?author：

CHEN Chang, Email: chenthoracic@163.com

Keywords：

4K fluorescence; domestic medical endoscopes; segmentectomy; lobectomy; Delphi; evaluation system; expert consensus

DOI：

10.7507/1007-4848.202509054

Video：

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Abstract Full text Figures/Tables Video References Cited by

The rapid development of domestically produced high-end medical endoscopes, particularly those incorporating 4K ultra-high-definition and fluorescence imaging, has shown significant promise in minimally invasive thoracic surgery. This expert consensus systematically delineates the clinical applications and value of these advanced technologies in various thoracic procedures, including wedge resection, anatomical segmentectomy, and bronchial sleeve resection. Furthermore, it establishes a scientific, quantitative evaluation system for these domestic thoracoscopes. The proposed framework comprises four primary indicators (reliability, efficiency & cost-effectiveness, clinical performance, and service & support) and 14 secondary indicators, each with a defined weight. This consensus aims to provide technical guidance for clinicians, direct future research and development for manufacturers, and ultimately promote the widespread adoption of high-quality domestic medical endoscopes, thereby advancing the national medical equipment industry.

Citation： CHEN Chang, Shanghai Medical Association Thoracic Surgery Branch, Shanghai Medical Doctor Association Thoracic Surgery Physician Branch, General Thoracic Surgery Clinical Capacity Promotion and Improvement Alliance. Expert consensus on evaluation indicators for the application of domestic high-end thoracoscopic thoracic surgery. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2026, 33(1): 13-18. doi: 10.7507/1007-4848.202509054 Copy

1.	中國醫療保健國際交流促進會胸外科分會, 中國抗癌協會肺部腫瘤整合康復專業委員會, 浙江省醫師協會胸外科醫師分會, 等. 4K 熒光高端國產醫用內窺鏡全國胸外科臨床應用評價專家共識 (2023). 中國胸心血管外科臨床雜志, 2024, 31(3): 337-342.Thoracic Surgery Branch of China International Exchange and Promotion Association for Medical and Healthcare, Integrated Rehabilitation Professional Committee for Lung Cancer of China Anti-Cancer Association, Thoracic Surgeon Branch of Zhejiang Medical Doctor Association, et al. Chinese expert consensus on clinical application evaluation of 4K fluorescence high-end domestic medical endoscopes in thoracic surgery (2023). Chin J Clin Thorac Cardiovasc Surg, 2024, 31(3): 337-342.
2.	王子豪, 王福強, 張含露, 等. 胸腔鏡的臨床功能及適用性評價體系構建研究. 中國胸心血管外科臨床雜志, 2020, 27(8): 893-899.Wang ZH, Wang FQ, Zhang HL, et al. Establishment of an evaluation system for thoracoscopic clinical function and applicability. Chin J Clin Thorac Cardiovasc Surg, 2020, 27(8): 893-899.
3.	Nwogu CE, D'Cunha J, Pang H, et al. VATS lobectomy has better peri-operative outcomes than open lobectomy: CALGB 31001, an ancillary analysis of CALGB 140202 (Alliance). Ann Thorac Surg, 2015, 99(2): 399-405.
4.	Kagimoto A, Ishida M, Mimura T. Utility of 4K three-dimensional endoscopic system in performing video-assisted thoracoscopic surgery lobectomy: initial results of the first year after installation. Gen Thorac Cardiovasc Surg, 2024, 72(8): 535-541.
5.	Yang C, Mo L, Ma Y, et al. A comparative analysis of lung cancer patients treated with lobectomy via three-dimensional video-assisted thoracoscopic surgery versus two-dimensional resection. J Thorac Dis, 2015, 7(10): 1798-1805.
6.	張曉斌, 張亞東, 周宇. 4K 一體化智能腔鏡系統的探究與應用. 中國醫療設備, 2021, 36(8): 54-57.Zhang XB, Zhang YD, Zhou Y. Exploration and application of 4K integrated intelligent endoscopic system. China Medical Equipment, 2021, 36(8): 54-57.
7.	Wahba R, Datta R, Bu?hoff J, et al. 3D versus 4K display system—influence of "tate-of-the-art"—display technique on surgical performance (IDOSP-study) in minimally invasive surgery: a randomized cross-over trial. Ann Surg, 2020, 272(5): 709-714.
8.	Singla V, Bhattacharjee HK, Gupta E, et al. Performance of three-dimensional and ultra-high-definition (4K) technology in laparoscopic surgery: a systematic review and meta-analysis. J Minim Access Surg, 2022, 18(2): 167-175.
9.	Schaafsma BE, Mieog JS, Hutteman M, et al. The clinical use of indocyanine green as a near-infrared fluorescent contrast agent for image-guided oncologic surgery. J Surg Oncol, 2011, 104(3): 323-332.
10.	Takamori S, Nakatsuka M, Watanabe H, et al. Segmental bronchial marking method using indocyanine green for safe thoracoscopic segmentectomy: a single-center early experience. J Thorac Dis, 2025, 17(5): 2958-2966.
11.	Wang L, Hu J, Gao J, et al. Artificial intelligence-assisted surgical simulation system based on non-enhanced computed tomography images in thoracoscopic pulmonary segmentectomies. J Thorac Dis, 2025, 17(8): 5787-5802.
12.	詹必成, 劉建, 陳劍, 等. 三維重建指導下單孔熒光胸腔鏡肺亞段切除肺結節的療效分析. 中華胸心血管外科雜志, 2024, 40(11): 641-646.Zhan BC, Liu J, Chen J, et al. Efficacy analysis of three-dimensional reconstruction-guided uniportal fluorescent thoracoscopic pulmonary subsegmentectomy for pulmonary nodules. Chin J Thorac Cardiovasc Surg, 2024, 40(11): 641-646.
13.	陳世雄, 陳勝家, 陳愷, 等. 單孔胸腔鏡支氣管袖式肺葉切除術臨床經驗. 中國微創外科雜志, 2022, 22(9): 739-742.Chen SX, Chen SJ, Chen K, et al. Clinical experience with uniportal video-assisted thoracoscopic bronchial sleeve lobectomy. Chin J Min Invas Surg, 2022, 22(9): 739-742.
14.	Watkins AA, Quadri SM, Servais EL. Robotic-assisted complex pulmonary resection: sleeve lobectomy for cancer. Innovations (Phila), 2021, 16(2): 132-135.
15.	Cloyd JM, Sarna A, Arango MJ, et al. Best practices for delivering neoadjuvant therapy in pancreatic ductal adenocarcinoma. JAMA Surg, 2025, 160(2): 172-180.
16.	Ferla G, Mura B, Falasco S, et al. Multi-criteria decision analysis (MCDA) for sustainability assessment in food sector. Sci Total Environ, 2024, 946: 174235.
17.	Gaievskyi S, Delfrate N, Ragazzoni L, et al. Use of multi-criteria decision analysis (MCDA) to support decision-making during health emergencies. Front Public Health, 2025, 13: 1584026.
18.	于曉初, 趙鵬, 焦亞輝, 等. 大型醫用設備成本效益分析評價體系的構建與研究. 中國醫院, 2016, 20(1): 10-12.Yu XC, Zhao P, Jiao YH, et al. Construction and research of cost-benefit analysis and evaluation system for large medical equipment. China Hospital, 2016, 20(1): 10-12.
19.	張和平, 尹軍, 魏安海, 等. 基于 AHP 和德爾菲法的醫療器械臨床使用評價指標體系構建. 中國醫療設備, 2021, 36(3): 120-124.Zhang HP, Yin J, Wei AH, et al. Construction of a clinical evaluation index system for medical devices based on AHP and Delphi method. Chin Med Equip, 2021, 36(3): 120-124.
20.	Fargen KM, Frei D, Fiorella D, et al. The FDA human factors guidance and neurointerventional devices. J Neurointerv Surg, 2015, 7(9): 646-648.
21.	Dalli ?E, Girgin NK. Medical device-related pressure injury knowledge assessment for nurses. J Wound Care, 2023, 32(Sup6a): lxxv-lxxxvi.
22.	桑維陌, 張帥. 基于多源數據分析的醫療設備異常運行狀態監測方法研究. 中國醫療設備, 2025, 40(9): 45-50.Sang WM, Zhang S. Research on the monitoring method of abnormal operation status of medical equipment based on multi-source data analysis. Chin Med Equip, 2025, 40(9): 45-50.
23.	Ogihara A, Omata M, Shidei H, et al. Intraoperative robotic surgical system-related problems in robot-assisted thoracoscopic surgery. Gen Thorac Cardiovasc Surg, 2024, 72(9): 593-598.
24.	Cohen D, Cragg M, Gao F, et al. Development of a key performance indicator framework for medical equipment management. J Med Eng Technol, 2019, 43(3): 139-150.
25.	國家藥品監督管理局醫療器械技術評審中心. 醫療器械臨床評價技術指導原則. (2021-04-30)[2024-05-01].National Medical Products Administration (NMPA) Medical Device Technical Review Center. Technical guidelines for clinical evaluation of medical devices. (2021-04-30)[2024-05-01].
26.	Bedawi EO, Stavroulias D, Hedley E, et al. Early video-assisted thoracoscopic surgery or intrapleural enzyme therapy in pleural infection. Am J Respir Crit Care Med, 2023, 208(12): 1305-1315.
27.	Tenorio C, de la Mata D, Leyva JAF, et al. Mexican radiation dermatitis management consensus. Rep Pract Oncol Radiother, 2022, 27(5): 914-926.
28.	Ferrando C, Carrami?ana A, Pi?eiro P, et al. Individualised, perioperative open-lung ventilation strategy during one-lung ventilation (iPROVE-OLV). Lancet Respir Med, 2024, 12(3): 195-206.
29.	Draeger TB, Gibson VR, Fernandes G, et al. Enhanced recovery after thoracic surgery (ERATS). Heart Lung Circ, 2021, 30(8): 1251-1255.
30.	Gonzalez M, Karenovics W, Bédat B, et al. Performance of prolonged air leak scoring systems in patients undergoing video-assisted thoracoscopic surgery segmentectomy. Eur J Cardiothorac Surg, 2022, 62(3): ezac100.
31.	Kim HJ, Kim M, Park B, et al. Feasibility of ventilator-assisted tubeless anesthesia for video-assisted thoracoscopic surgery. Medicine (Baltimore), 2023, 102(28): e34220.
32.	Markowiak T, Ried M, Gro?er C, et al. Postoperative outcome after palliative treatment of malignant pleural effusion. Thorac Cancer, 2022, 13(15): 2158-2163.
33.	Beeton G, Ngatuvai M, Breeding T, et al. Outcomes of pigtail catheter placement versus chest tube placement in adult thoracic trauma patients: a systematic review and meta-analysis. Am Surg, 2023, 89(6): 2743-2754.
34.	Crook R, Walker S, Maskell N. Treatment of malignant pleural effusions. Clin Chest Med, 2025, 46(2): 227-240.
35.	王豐. 真實世界研究在醫療器械全生命周期中的應用. 醫療裝備, 2023, 36(3): 24-28.Wang F. Real-world research in the application of the entire life cycle of medical devices. Med Equip, 2023, 36(3): 24-28.
36.	尚樸, 單彬, 段麗娟, 等. 醫療器械臨床試驗綜合評價指標體系的構建. 中國醫療設備, 2024, 39(9): 119-124.Shang P, Shan B, Duan LJ, et al. Construction of a comprehensive evaluation index system for clinical trials of medical devices. Chin Med Equip, 2024, 39(9): 119-124.
37.	Spencer BL, Lotakis DM, Vaishnav A, et al. Implications of using a clinical practice guideline on outcomes in pediatric empyema. J Surg Res, 2024, 303: 390-395.
38.	Lee JH, Park TH, Kim HK. Robotic thoracic surgery using the single-port robotic system: initial experience with more than 100 cases. J Thorac Cardiovasc Surg, 2024, 168(6): 1513-1522.
39.	Abdurahiman N, Khorasani M, Padhan J, et al. Scope actuation system for articulated laparoscopes. Surg Endosc, 2023, 37(3): 2404-2413.
40.	Carver TW, Berndtson AE, McNickle AG, et al. Thoracic irrigation for prevention of secondary intervention after thoracostomy tube drainage for hemothorax. J Trauma Acute Care Surg, 2024, 97(5): 724-730.
41.	Al Tannir AH, Biesboer EA, Golestani S, et al. Thoracic cavity irrigation prevents retained hemothorax and decreases surgical intervention in trauma patients. J Trauma Acute Care Surg, 2024, 97(1): 90-95.
42.	Ayyad RF, Ayyad A, Sweity R, et al. Stapler-less uniportal video-assisted thoracoscopic surgery: a case series and review of the literature. Ann Thorac Cardiovasc Surg, 2025, 31(1): 25-00009.

1. 中國醫療保健國際交流促進會胸外科分會, 中國抗癌協會肺部腫瘤整合康復專業委員會, 浙江省醫師協會胸外科醫師分會, 等. 4K 熒光高端國產醫用內窺鏡全國胸外科臨床應用評價專家共識 (2023). 中國胸心血管外科臨床雜志, 2024, 31(3): 337-342.Thoracic Surgery Branch of China International Exchange and Promotion Association for Medical and Healthcare, Integrated Rehabilitation Professional Committee for Lung Cancer of China Anti-Cancer Association, Thoracic Surgeon Branch of Zhejiang Medical Doctor Association, et al. Chinese expert consensus on clinical application evaluation of 4K fluorescence high-end domestic medical endoscopes in thoracic surgery (2023). Chin J Clin Thorac Cardiovasc Surg, 2024, 31(3): 337-342.
2. 王子豪, 王福強, 張含露, 等. 胸腔鏡的臨床功能及適用性評價體系構建研究. 中國胸心血管外科臨床雜志, 2020, 27(8): 893-899.Wang ZH, Wang FQ, Zhang HL, et al. Establishment of an evaluation system for thoracoscopic clinical function and applicability. Chin J Clin Thorac Cardiovasc Surg, 2020, 27(8): 893-899.
3. Nwogu CE, D'Cunha J, Pang H, et al. VATS lobectomy has better peri-operative outcomes than open lobectomy: CALGB 31001, an ancillary analysis of CALGB 140202 (Alliance). Ann Thorac Surg, 2015, 99(2): 399-405.
4. Kagimoto A, Ishida M, Mimura T. Utility of 4K three-dimensional endoscopic system in performing video-assisted thoracoscopic surgery lobectomy: initial results of the first year after installation. Gen Thorac Cardiovasc Surg, 2024, 72(8): 535-541.
5. Yang C, Mo L, Ma Y, et al. A comparative analysis of lung cancer patients treated with lobectomy via three-dimensional video-assisted thoracoscopic surgery versus two-dimensional resection. J Thorac Dis, 2015, 7(10): 1798-1805.
6. 張曉斌, 張亞東, 周宇. 4K 一體化智能腔鏡系統的探究與應用. 中國醫療設備, 2021, 36(8): 54-57.Zhang XB, Zhang YD, Zhou Y. Exploration and application of 4K integrated intelligent endoscopic system. China Medical Equipment, 2021, 36(8): 54-57.
7. Wahba R, Datta R, Bu?hoff J, et al. 3D versus 4K display system—influence of "tate-of-the-art"—display technique on surgical performance (IDOSP-study) in minimally invasive surgery: a randomized cross-over trial. Ann Surg, 2020, 272(5): 709-714.
8. Singla V, Bhattacharjee HK, Gupta E, et al. Performance of three-dimensional and ultra-high-definition (4K) technology in laparoscopic surgery: a systematic review and meta-analysis. J Minim Access Surg, 2022, 18(2): 167-175.
9. Schaafsma BE, Mieog JS, Hutteman M, et al. The clinical use of indocyanine green as a near-infrared fluorescent contrast agent for image-guided oncologic surgery. J Surg Oncol, 2011, 104(3): 323-332.
10. Takamori S, Nakatsuka M, Watanabe H, et al. Segmental bronchial marking method using indocyanine green for safe thoracoscopic segmentectomy: a single-center early experience. J Thorac Dis, 2025, 17(5): 2958-2966.
11. Wang L, Hu J, Gao J, et al. Artificial intelligence-assisted surgical simulation system based on non-enhanced computed tomography images in thoracoscopic pulmonary segmentectomies. J Thorac Dis, 2025, 17(8): 5787-5802.
12. 詹必成, 劉建, 陳劍, 等. 三維重建指導下單孔熒光胸腔鏡肺亞段切除肺結節的療效分析. 中華胸心血管外科雜志, 2024, 40(11): 641-646.Zhan BC, Liu J, Chen J, et al. Efficacy analysis of three-dimensional reconstruction-guided uniportal fluorescent thoracoscopic pulmonary subsegmentectomy for pulmonary nodules. Chin J Thorac Cardiovasc Surg, 2024, 40(11): 641-646.
13. 陳世雄, 陳勝家, 陳愷, 等. 單孔胸腔鏡支氣管袖式肺葉切除術臨床經驗. 中國微創外科雜志, 2022, 22(9): 739-742.Chen SX, Chen SJ, Chen K, et al. Clinical experience with uniportal video-assisted thoracoscopic bronchial sleeve lobectomy. Chin J Min Invas Surg, 2022, 22(9): 739-742.
14. Watkins AA, Quadri SM, Servais EL. Robotic-assisted complex pulmonary resection: sleeve lobectomy for cancer. Innovations (Phila), 2021, 16(2): 132-135.
15. Cloyd JM, Sarna A, Arango MJ, et al. Best practices for delivering neoadjuvant therapy in pancreatic ductal adenocarcinoma. JAMA Surg, 2025, 160(2): 172-180.
16. Ferla G, Mura B, Falasco S, et al. Multi-criteria decision analysis (MCDA) for sustainability assessment in food sector. Sci Total Environ, 2024, 946: 174235.
17. Gaievskyi S, Delfrate N, Ragazzoni L, et al. Use of multi-criteria decision analysis (MCDA) to support decision-making during health emergencies. Front Public Health, 2025, 13: 1584026.
18. 于曉初, 趙鵬, 焦亞輝, 等. 大型醫用設備成本效益分析評價體系的構建與研究. 中國醫院, 2016, 20(1): 10-12.Yu XC, Zhao P, Jiao YH, et al. Construction and research of cost-benefit analysis and evaluation system for large medical equipment. China Hospital, 2016, 20(1): 10-12.
19. 張和平, 尹軍, 魏安海, 等. 基于 AHP 和德爾菲法的醫療器械臨床使用評價指標體系構建. 中國醫療設備, 2021, 36(3): 120-124.Zhang HP, Yin J, Wei AH, et al. Construction of a clinical evaluation index system for medical devices based on AHP and Delphi method. Chin Med Equip, 2021, 36(3): 120-124.
20. Fargen KM, Frei D, Fiorella D, et al. The FDA human factors guidance and neurointerventional devices. J Neurointerv Surg, 2015, 7(9): 646-648.
21. Dalli ?E, Girgin NK. Medical device-related pressure injury knowledge assessment for nurses. J Wound Care, 2023, 32(Sup6a): lxxv-lxxxvi.
22. 桑維陌, 張帥. 基于多源數據分析的醫療設備異常運行狀態監測方法研究. 中國醫療設備, 2025, 40(9): 45-50.Sang WM, Zhang S. Research on the monitoring method of abnormal operation status of medical equipment based on multi-source data analysis. Chin Med Equip, 2025, 40(9): 45-50.
23. Ogihara A, Omata M, Shidei H, et al. Intraoperative robotic surgical system-related problems in robot-assisted thoracoscopic surgery. Gen Thorac Cardiovasc Surg, 2024, 72(9): 593-598.
24. Cohen D, Cragg M, Gao F, et al. Development of a key performance indicator framework for medical equipment management. J Med Eng Technol, 2019, 43(3): 139-150.
25. 國家藥品監督管理局醫療器械技術評審中心. 醫療器械臨床評價技術指導原則. (2021-04-30)[2024-05-01].National Medical Products Administration (NMPA) Medical Device Technical Review Center. Technical guidelines for clinical evaluation of medical devices. (2021-04-30)[2024-05-01].
26. Bedawi EO, Stavroulias D, Hedley E, et al. Early video-assisted thoracoscopic surgery or intrapleural enzyme therapy in pleural infection. Am J Respir Crit Care Med, 2023, 208(12): 1305-1315.
27. Tenorio C, de la Mata D, Leyva JAF, et al. Mexican radiation dermatitis management consensus. Rep Pract Oncol Radiother, 2022, 27(5): 914-926.
28. Ferrando C, Carrami?ana A, Pi?eiro P, et al. Individualised, perioperative open-lung ventilation strategy during one-lung ventilation (iPROVE-OLV). Lancet Respir Med, 2024, 12(3): 195-206.
29. Draeger TB, Gibson VR, Fernandes G, et al. Enhanced recovery after thoracic surgery (ERATS). Heart Lung Circ, 2021, 30(8): 1251-1255.
30. Gonzalez M, Karenovics W, Bédat B, et al. Performance of prolonged air leak scoring systems in patients undergoing video-assisted thoracoscopic surgery segmentectomy. Eur J Cardiothorac Surg, 2022, 62(3): ezac100.
31. Kim HJ, Kim M, Park B, et al. Feasibility of ventilator-assisted tubeless anesthesia for video-assisted thoracoscopic surgery. Medicine (Baltimore), 2023, 102(28): e34220.
32. Markowiak T, Ried M, Gro?er C, et al. Postoperative outcome after palliative treatment of malignant pleural effusion. Thorac Cancer, 2022, 13(15): 2158-2163.
33. Beeton G, Ngatuvai M, Breeding T, et al. Outcomes of pigtail catheter placement versus chest tube placement in adult thoracic trauma patients: a systematic review and meta-analysis. Am Surg, 2023, 89(6): 2743-2754.
34. Crook R, Walker S, Maskell N. Treatment of malignant pleural effusions. Clin Chest Med, 2025, 46(2): 227-240.
35. 王豐. 真實世界研究在醫療器械全生命周期中的應用. 醫療裝備, 2023, 36(3): 24-28.Wang F. Real-world research in the application of the entire life cycle of medical devices. Med Equip, 2023, 36(3): 24-28.
36. 尚樸, 單彬, 段麗娟, 等. 醫療器械臨床試驗綜合評價指標體系的構建. 中國醫療設備, 2024, 39(9): 119-124.Shang P, Shan B, Duan LJ, et al. Construction of a comprehensive evaluation index system for clinical trials of medical devices. Chin Med Equip, 2024, 39(9): 119-124.
37. Spencer BL, Lotakis DM, Vaishnav A, et al. Implications of using a clinical practice guideline on outcomes in pediatric empyema. J Surg Res, 2024, 303: 390-395.
38. Lee JH, Park TH, Kim HK. Robotic thoracic surgery using the single-port robotic system: initial experience with more than 100 cases. J Thorac Cardiovasc Surg, 2024, 168(6): 1513-1522.
39. Abdurahiman N, Khorasani M, Padhan J, et al. Scope actuation system for articulated laparoscopes. Surg Endosc, 2023, 37(3): 2404-2413.
40. Carver TW, Berndtson AE, McNickle AG, et al. Thoracic irrigation for prevention of secondary intervention after thoracostomy tube drainage for hemothorax. J Trauma Acute Care Surg, 2024, 97(5): 724-730.
41. Al Tannir AH, Biesboer EA, Golestani S, et al. Thoracic cavity irrigation prevents retained hemothorax and decreases surgical intervention in trauma patients. J Trauma Acute Care Surg, 2024, 97(1): 90-95.
42. Ayyad RF, Ayyad A, Sweity R, et al. Stapler-less uniportal video-assisted thoracoscopic surgery: a case series and review of the literature. Ann Thorac Cardiovasc Surg, 2025, 31(1): 25-00009.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Expert consensus on evaluation indicators for the application of domestic high-end thoracoscopic thoracic surgery

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