Background: A disturbance of the superficial lymphatic system (dermal backflow) in patients with breast cancer-related lymphedema (BCRL) can be visualized by near-infrared fluorescence imaging or lymphofluoroscopy. In clinical practice, exact measurement of the dermal backflow is difficult. The purpose of the study is to investigate the concurrent validity between the clinical assessments and the lymphofluoroscopy in patients with BCRL. Methods and Results: Forty-five patients with BCRL stage I to IIb received lymphofluoroscopy and clinical assessments of their edematous limb (pitting status, skinfold thickness, skin elasticity, water content, lymphedema volume, and extracellular fluid). The correlation between the clinical assessments and the result of the lymphofluoroscopy was determined. The best overall agreement with dermal backflow was found for the clinical assessment pitting status, skinfold thickness, and water content. Overall sensitivity was excellent for lymphedema volume (92.5%), high for skinfold thickness (86.6%) and water content (75.0%), and moderate for pitting status (67.7%). Overall specificity was excellent for skin elasticity (94.7%), high for pitting status (83.4%), and moderate for skinfold thickness (61.6%) and water content (74.8%). In the evaluation of the whole arm, measurements of the excess volume were significantly greater for patients in an advanced stage of dermal backflow in comparison with patients in an earlier stage of dermal backflow (p = 0.002). Conclusions: The clinical assessments of skinfold thickness, water content, and lymphedema volume are the most appropriate tools to detect dermal backflow according to the lymphofluoroscopic images. To confirm the absence of dermal backflow, pitting status can be recommended.

The objective of this trial was to investigate the effectiveness of fluoroscopy-guided manual lymph drainage (MLD), as part of decongestive lymphatic therapy (DLT), on the superficial lymphatic architecture in patients with chronic mild to moderate breast cancer-related lymphoedema (BCRL). This trial was a multicentre, double-blind, randomised controlled trial involving 194 participants with BCRL. Participants were randomised into (1) DLT with fluoroscopy-guided MLD (intervention group), (2) DLT with traditional MLD (control group), or (3) DLT with placebo MLD (placebo group). Superficial lymphatic architecture was evaluated as a secondary outcome, visualised by ICG lymphofluoroscopy at the baseline (B0), post-intensive (P), and post-maintenance phases (P6). Variables were (1) number of efferent superficial lymphatic vessels leaving the dermal backflow region, (2) total dermal backflow score, and (3) number of superficial lymph nodes. The traditional MLD group showed a significant decrease in the number of efferent superficial lymphatic vessels at P (p = 0.026), and of the total dermal backflow score at P6 (p = 0.042). The fluoroscopy-guided MLD and placebo group showed significant decreases in the total dermal backflow score at P (p < 0.001 and p = 0.044, respectively) and at P6 (p < 0.001 and p = 0.007, respectively); the placebo MLD group showed a significant decrease in the total number of lymph nodes at P (p = 0.008). However, there were no significant between-group differences for the changes in these variables. In conclusion, based on lymphatic architecture outcomes, the added value of MLD, in addition to the other parts of DLT, could not be demonstrated in patients with chronic mild to moderate BCRL.