Protocol for China endoscopic and robotic breast surgery guidelines (2026 edition)_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

 DU Zhenggui ¹ ,  Lü Qing ¹ , Lü Pengwei ² , SONG Dajiang ³ , WANG Zihan ⁴ , YANG Benlong ⁵ , SU Shicheng ⁶

1. Breast Disease Center of West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;
2. Department of Breast Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, P. R. China;
3. Department of Oncologic Plastic Surgery, Hunan Cancer Hospital, Changsha, 410013, P. R. China;
4. Department of Breast Surgery, Beijing Chao-yang Hospital, Capital Medical University, Beijing, 100020, P. R. China;
5. Breast Surgery Department, Fudan University Shanghai Cancer Center, Shanghai, 200032, P. R. China;
6. Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, 510120, P. R. China;

Corresponding?author：

DU Zhenggui, Email: docduzg@163.com; Lü Qing, Email: lqlq1963@163.com

Keywords：

Breast cancer; endoscopic breast surgery; robotic breast surgery; guideline; protocol; test; evidence

DOI：

10.7507/1007-4848.202601080

Video：

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Breast cancer is the most common malignant tumor among women in China, with surgery being one of the primary treatment modalities. Endoscopic/robotic breast surgery (ErBS) is gaining widespread acceptance among patients and surgeons alike due to its advantages of minimal invasiveness, superior cosmetic outcomes, and accelerated recovery. However, substantial heterogeneity currently exists across China regarding patient selection, standardized operative techniques, perioperative management, and complication handling, underscoring the urgent need for evidence-based consensus guidelines. To promote standardization and ensure consistent quality of ErBS, the Chinese Endoscopic-Robotic Breast Surgery Clinical Trials Consortium (CErBSCTC) has systematically reviewed the latest high-quality evidence and formulated the "Protocol for the China Endoscopic and Robotic Breast Surgery Guidelines (2026 edition)," which outlines a comprehensive methodology for guideline development.

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2.	Kim J, Harper A, McCormack V, et al. Global patterns and trends in breast cancer incidence and mortality across 185 countries. Nat Med, 2025, 31(4): 1154-1162.
3.	Lai HW, Chen ST, Tai CM, et al. Robotic- versus endoscopic-assisted nipple-sparing mastectomy with immediate prosthesis breast reconstruction in the management of breast cancer: a case-control comparison study with analysis of clinical outcomes, learning curve, patient-reported aesthetic results, and medical cost. Ann Surg Oncol, 2020, 27(7): 2255-2268.
4.	Carroll A, Robles C, Lai HW, et al. Oncological, surgical, and cosmetic outcomes of endoscopic versus conventional nipple-sparing mastectomy: meta-analysis. BJS Open, 2025, 9(3): zraf011.
5.	Kim JH, Ryu JM, Bae SJ, et al. Minimal access vs conventional nipple-sparing mastectomy. JAMA Surg, 2024, 159(10): 1177-1186.
6.	Lai HW, Chen DR, Liu LC, et al. Robotic versus conventional or endoscopic-assisted nipple-sparing mastectomy and immediate prosthesis breast reconstruction in the management of breast cancer: a prospectively designed multicenter trial comparing clinical outcomes, medical cost, and patient-reported outcomes (RCENSM-P). Ann Surg, 2024, 279(1): 138-146.
7.	Wan A, Liang Y, Chen L, et al. Association of long-term oncologic prognosis with minimal access breast surgery vs conventional breast surgery. JAMA Surg, 2022, 157(12): e224711.
8.	Wang ZH, Gao GX, Liu WH, et al. Single-port nipple-sparing subcutaneous mastectomy with immediate prosthetic breast reconstruction for breast cancer. Surg Endosc, 2023, 37(5): 3842-3851.
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12.	Shannath M, Serge R, Bedri KA, et al. WHO Handbook for Guideline Development: 2nd edition. Geneva: World Health Organization, 2014: 1-17.
13.	陳耀龍, 楊克虎, 王小欽, 等. 中國制訂/修訂臨床診療指南的指導原則(2022版). 中華醫學雜志, 2022, 102(10): 697-703.Chen YL, Yang KH, Wang XQ, et al. Principles and methods of development of Chinese clinical practice guidelines (2022 edition). Natl Med J China, 2022, 102(10): 697-703.
14.	Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ, 2004, 328(7454): 1490.
15.	Durieux N, Vandenput S, Pasleau F. OCEBM levels of evidence system. Rev Med Liege, 2013, 68(12): 644-649.
16.	Brouwers MC, Kerkvliet K, Spithoff K. The AGREE reporting checklist: a tool to improve reporting of clinical practice guidelines. BMJ, 2016, 352: i1152.
17.	Chen Y, Yang K, Maru?ic A, et al. A reporting tool for practice guidelines in health care: the RIGHT statement. Ann Intern Med, 2017, 166(2): 128-132.
18.	Sterne JAC, Savovi? J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ, 2019, 366: l4898.
19.	Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ, 2016, 355: i4919.
20.	Whiting PF, Rutjes AWS, Westwood ME, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med, 2011, 155(8): 529-536.
21.	AGREE-REX研究團隊, 王瑞, 張崇凡. 指南研究與評估系統: 最佳推薦意見的質量評價工具(AGREE-REX). 中國循證兒科雜志, 2020, 15(6): 476-480.The AGREE-REX Research Team, Wang R, Zhang CF. AGREE-REX: a tool for assessing the quality of clinical practice guideline recommendations. Chin J Evid Based Pediatr, 2020, 15(6): 476-480.

1. Sun K, Zhang B, Lei S, et al. Incidence, mortality, and disability-adjusted life years of female breast cancer in China, 2022. Chin Med J (Engl), 2024, 137(20): 2429-2436.
2. Kim J, Harper A, McCormack V, et al. Global patterns and trends in breast cancer incidence and mortality across 185 countries. Nat Med, 2025, 31(4): 1154-1162.
3. Lai HW, Chen ST, Tai CM, et al. Robotic- versus endoscopic-assisted nipple-sparing mastectomy with immediate prosthesis breast reconstruction in the management of breast cancer: a case-control comparison study with analysis of clinical outcomes, learning curve, patient-reported aesthetic results, and medical cost. Ann Surg Oncol, 2020, 27(7): 2255-2268.
4. Carroll A, Robles C, Lai HW, et al. Oncological, surgical, and cosmetic outcomes of endoscopic versus conventional nipple-sparing mastectomy: meta-analysis. BJS Open, 2025, 9(3): zraf011.
5. Kim JH, Ryu JM, Bae SJ, et al. Minimal access vs conventional nipple-sparing mastectomy. JAMA Surg, 2024, 159(10): 1177-1186.
6. Lai HW, Chen DR, Liu LC, et al. Robotic versus conventional or endoscopic-assisted nipple-sparing mastectomy and immediate prosthesis breast reconstruction in the management of breast cancer: a prospectively designed multicenter trial comparing clinical outcomes, medical cost, and patient-reported outcomes (RCENSM-P). Ann Surg, 2024, 279(1): 138-146.
7. Wan A, Liang Y, Chen L, et al. Association of long-term oncologic prognosis with minimal access breast surgery vs conventional breast surgery. JAMA Surg, 2022, 157(12): e224711.
8. Wang ZH, Gao GX, Liu WH, et al. Single-port nipple-sparing subcutaneous mastectomy with immediate prosthetic breast reconstruction for breast cancer. Surg Endosc, 2023, 37(5): 3842-3851.
9. Wu Z, Kim H, Lee J, et al. Long-term oncologic outcomes of immediate breast reconstruction vs conventional mastectomy alone for breast cancer in the setting of neoadjuvant chemotherapy. JAMA Surg, 2020, 155(12): 1142-1150.
10. 謝妍妍, 呂青, 杜正貴. 乳腺腔鏡和機器人手術的現狀及未來之路—華西醫院經驗分享. 外科理論與實踐, 2022, 27(5): 396-402.Xie YY, Lyu Q, Du ZG. Present and future of breast endoscopic and robotic surgery: experience from West China Hospital. J Surg Concepts Pract, 2022, 27(5): 396-402.
11. 中國抗癌協會乳腺癌專業委員會, 中國醫師協會外科醫師分會乳腺外科醫師委員會, 上海市抗癌協會乳腺癌專業委員會. 乳腺腫瘤整形與乳房重建專家共識(2022年版). 中國癌癥雜志, 2022, 32(9): 836-924.Breast Cancer Committee of China Anti-Cancer Association, Breast Surgeon Committee of Surgeon Branch of Chinese Medical Doctor Association, Breast Cancer Committee of Shanghai Anti-Cancer Association. Expert consensus on oncoplastic surgery and breast reconstruction for breast cancer (2022 edition). China Oncol, 2022, 32(9): 836-924.
12. Shannath M, Serge R, Bedri KA, et al. WHO Handbook for Guideline Development: 2nd edition. Geneva: World Health Organization, 2014: 1-17.
13. 陳耀龍, 楊克虎, 王小欽, 等. 中國制訂/修訂臨床診療指南的指導原則(2022版). 中華醫學雜志, 2022, 102(10): 697-703.Chen YL, Yang KH, Wang XQ, et al. Principles and methods of development of Chinese clinical practice guidelines (2022 edition). Natl Med J China, 2022, 102(10): 697-703.
14. Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ, 2004, 328(7454): 1490.
15. Durieux N, Vandenput S, Pasleau F. OCEBM levels of evidence system. Rev Med Liege, 2013, 68(12): 644-649.
16. Brouwers MC, Kerkvliet K, Spithoff K. The AGREE reporting checklist: a tool to improve reporting of clinical practice guidelines. BMJ, 2016, 352: i1152.
17. Chen Y, Yang K, Maru?ic A, et al. A reporting tool for practice guidelines in health care: the RIGHT statement. Ann Intern Med, 2017, 166(2): 128-132.
18. Sterne JAC, Savovi? J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ, 2019, 366: l4898.
19. Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ, 2016, 355: i4919.
20. Whiting PF, Rutjes AWS, Westwood ME, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med, 2011, 155(8): 529-536.
21. AGREE-REX研究團隊, 王瑞, 張崇凡. 指南研究與評估系統: 最佳推薦意見的質量評價工具(AGREE-REX). 中國循證兒科雜志, 2020, 15(6): 476-480.The AGREE-REX Research Team, Wang R, Zhang CF. AGREE-REX: a tool for assessing the quality of clinical practice guideline recommendations. Chin J Evid Based Pediatr, 2020, 15(6): 476-480.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

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