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Application of mitoxantrone hydrochloride injection for tracing in transoral robotic thyroid cancer surgery: a prospective randomized controlled study
LUO Fu, ZHANG Gang, GUO Ling-ji, JIANG Yan, YU Fan, XU Jing, HUANG Yu-shu, WANG Ling-li, YAN Jie, XU Yan
Chinese Journal of Practical Surgery ›› 2026, Vol. 46 ›› Issue (6) : 804-809.
PDF(1840 KB)
PDF(1840 KB)
Application of mitoxantrone hydrochloride injection for tracing in transoral robotic thyroid cancer surgery: a prospective randomized controlled study
Objective To evaluate the efficacy and safety of mitoxantrone hydrochloride injection for tracing (MHI) in assisting central lymph node dissection and parathyroid gland protection during transoral robotic thyroidectomy. Methods A prospective, single-center, and randomized controlled clinical trial was conducted. A total of 114 patients who underwent transoral robotic thyroidectomy at the Department of Breast and Thyroid Surgery, Daping Hospital, Army Medical University, between February 2024 and November 2025 were enrolled and randomly assigned at a 1∶1 ratio to the experimental group and the control group, with 57 patients in each group. MHI was injected intraoperatively into the thyroid gland at multiple sites in the experimental group, whereas no lymphatic tracer was used in the control group. The number of dissected central lymph nodes, number of positive lymph nodes detected, rate of inadvertent parathyroidectomy, postoperative changes in parathyroid hormone (PTH) and serum calcium levels, postoperative complications, and adverse reactions were compared between the two groups. Results There were no statistically significant differences in the baseline characteristics between the two groups. The number of dissected central lymph nodes was higher in the experimental group than in the control group [6.0 (4.0, 9.0) vs. 5.0 (3.0, 7.0), P=0.022]. The number of detected positive lymph nodes [1.0 (0.0, 2.0) vs. 0.0 (0.0, 2.0), P=0.518] was not statistically significant. In the experimental group, the staining rate of central lymph nodes was 88.6%, and the tracing rate of positive lymph nodes was 91.6%. The rate of inadvertent parathyroidectomy was lower in the experimental group than in the control group [3.5% (2/57) vs.10.5% (6/57)], but the difference was not statistically significant (P=0.271). No statistically significant differences were observed between the two groups in PTH or serum calcium levels on postoperative days 1 and 7, or in the incidence of transient hypoparathyroidism, transient hypocalcemia, infection, and recurrent laryngeal nerve injury (all P>0.05). Conclusion MHI has a favorable central lymph node tracing effect in transoral robotic thyroidectomy, increases the number of dissected central lymph nodes, and does not increase postoperative complications. Its clinical benefit in inadvertent parathyroid excision has not reached statistical significance and needs to be further validated in multicenter studies with larger sample sizes.
thyroid cancer / mitoxantrone hydrochloride injection for tracing / transoral robotic thyroidectomy / lymph node dissection / parathyroid gland
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The identification and preservation of parathyroid glands (PGs) during thyroid surgery can be challenging. Many techniques have been developed to help surgeons find PGs. We have developed a novel mitoxantrone hydrochloride injection that can be used for lymphatic targeting. After local application during surgery, mitoxantrone hydrochloride injection for tracing (MHI) helps surgeons better identify and preserve PGs and helps pathologists find more lymph nodes. We conducted an open-label, multicenter, randomized clinical trial (CTR20171137) in six centers in China from 08/2017 to 12/2018. Patients with thyroid carcinoma were randomized to the MHI group or the control group. All patients received total thyroidectomy and bilateral central compartment lymph node dissection. The primary outcomes were the PG resection rate and lymph node staining rate. The full analysis set (FAS) included 461 patients, of which 228 were assigned to the MHI group, and 233 were assigned to the control group. The PG resection rates of the MHI group and the control group were 6.6% (15/228) and 26.6% (62/233), respectively, with a significant difference (P < 0.001). No PGs were stained blue with MHI. The central lymph nodes were stained blue with MHI, and the staining rate was 90.5%±12.0%. More lymph nodes were detected in the MHI group than in the control group (13.0±7.3 vs. 10.1±6.4 nodes/patient, P < 0.001). No adverse events related to MHI were observed. MHI is a safe and effective tracer that may help to preserve PGs and identify more central lymph nodes in patients with thyroid cancer.AJCR Copyright © 2022.
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