Postoperative upper limb edema and dysfunction generated by axillary node excision with or without axillary vein tributary preservation in breast cancer patients (PLEDGE-Surgery): a randomized controlled study

Background: The incidence of upper limb lymphedema and dysfunction caused by axillary lymph node dissection (ALND) in breast cancer patients is high, and there is a lack of effective prevention strategies. Methods: We conducted a multicenter, prospective, double-blind, randomized, controlled clinical study to compare the effects of ALND with or without axillary vein tributary preservation on the incidence of postoperative upper limb edema and dysfunction in breast cancer patients. Patients aged 18–69 years with stage II–III breast cancer requiring ALND were enrolled. The primary endpoint was the incidence of postoperative short-term upper limb lymphedema and dysfunction on the affected side. All randomly allocated patients were included in the final follow-up and analysis. Findings: From January 3rd, 2022 to April 1st, 2024, 258 female patients were randomly assigned to the intervention group(n = 87) or the control group (n = 171). The median age was 54 years in the intervention group and 53 years in the control group. The median follow-up was 15.1 months in the intervention group and 13.4 months in the control group. The 6-month and 12-month incidences of lymphedema in the intervention group were significantly lower than those in the control group (6-month: 0% vs. 10.78%, ARR (absolute risk reduction) 10.78%, P <0.001; OR (odds ratio) 0.143, 95% CI [0.065, 0.311]. 12-month: 2.38% vs. 16.18%, ARR 13.8%, P <0.001; OR 0.289, 95% CI [0.188, 0.446]). According to the results of the general linear model analysis, the mean DASH (disabilities of the arm, shoulder and hand) scores in the intervention group were lower than those in the control group (F = 10.167, P = 0.002). The results of multivariate logistic regression analysis revealed that preserving axillary vein tributaries during ALND was a protective factor for postoperative upper limb edema, whereas stage III, extensive lymphadenectomy (level 2/3), radiotherapy and postoperative infection were risk factors. No serious complications or deaths related to the operation occurred. Interpretation: ALND with axillary vein tributary preservation is beneficial for reducing the short-term incidence of postoperative upper limb edema and dysfunction, which is worth promoting in breast cancer patients who need ALND.