Trial reportBreast (Edinburgh, Scotland)2026
Minimal incision-assisted endoscopic versus conventional open breast-conserving surgery: A multicentre randomized clinical trial.
Trial report in Breast (Edinburgh, Scotland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
12 authors.
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Abstract
backgroundCompared with conventional open breast-conserving surgery (BCS), conventional endoscopic (E-BCS) mostly involves dual incisions, which provide an insignificant scarring benefit but increase the surgical difficulty and prolong the surgical time. In contrast, the novel minimal incision-assisted E-BCS (M-E-BCS) procedure enables a near-scarless operation with efficient and precise tumour resection through a single axillary incision.
methodsThis is a phase III, open-label, multicentre, superiority, randomized controlled trial conducted in 3 class IIIA hospitals in China. Patients were assigned to M-E-BCS or conventional open BCS (C-O-BCS). The aim was to compare aesthetic outcomes, surgical efficiency, and safety. The primary endpoint was the patient-reported SCAR-Q score for scar appearance satisfaction at 18 months postoperatively. Secondary endpoints included aesthetic outcomes, quality of life (QoL), operative time, complications, and oncologic outcomes.
resultsOverall, 163 patients were analysed, with 82 in the M-E-BCS group and 81 in the C-O-BCS group. The 18-month SCAR-Q score was available for 155 patients (8 missing, 4 per group). M-E-BCS demonstrated superior SCAR-Q scores (79.9 ± 9.5 vs. 61.4 ± 17.4, P < 0.001), greater improvement in BREAST-Q breast satisfaction (17.7 ± 18.2 vs. 5.4 ± 21.5, P < 0.001), and better psychosocial well-being (10.1 ± 19.2 vs. 0.1 ± 19.3, P = 0.001) at 18 months. The physician assessment (Ueda score) showed a higher "excellent" rate for M-E-BCS (86.5% vs. 57.9%). Operative time (130.8 ± 37.9 vs. 121.8 ± 30.5 min, P = 0.167), complication rates (11.0% vs. 13.6%, P = 0.612), and short-term oncologic outcomes were not significantly different between groups. The median follow-up was 30.0 months (range 19.0-45.0 months). One patient in the C-O-BCS group developed bone metastasis at 5 months, and another developed axillary lymph node recurrence at 17 months. No local recurrence or death occurred in either group.
conclusionM-E-BCS significantly improves aesthetic outcomes and QoL compared to C-O-BCS, without compromising surgical efficiency or safety for early-stage breast cancer patients, supporting its clinical adoption.
trial registrationChiCTR2200061907.
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