Prerandomization Surgical Training for the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-32 trial: a randomized phase III clinical trial to compare sentinel node resection to conventional axillary dissection in clinically node-negative breast cancer.

摘要: Sentinel node biopsy (SNB) is a minimally invasive procedure that allows the surgeon to accurately remove set of lymph nodes first receive drainage from primary tumor. This an attractive alternative conventional axillary resection (ANR) because it results in removal less node-bearing tissue and tumor-bearing can be identified if they are located outside axilla. The reasons for performing regional breast cancer maximize survival, provide long-term disease control, obtain important staging information. Collectively, randomized trials comparing ANR omission indicate survival advantage associated with 5.4% (95% confidence interval = 2.7% 8.0%).1 Modern reviews large sets patients also show reduction ANR.2 association decreased has been noted even early (T1a-b) stage cancers.3 outcome SNB direct comparison unknown. The National Surgical Adjuvant Breast Bowel Project clinical group (NSABP) partnership University Vermont conducting trial, B-32, determine whether alone will same control as clinically node-negative patients.4 endpoints B-32 trial morbidity. To detect possible difference small 2% between 2 groups, about 5600 enrolled. Several different techniques available there no consensus optimal method. minimize potential negative impact could have on interpretation outcomes single standardized method was chosen. Our preliminary experience multicenter validation sentinel study demonstrated intraoperative instruction, surgeons achieve overall technical success rates false-negative consistent international experience.5 We learned process generating source documentation capturing real-time elements surgical into field-based data collection form were activities not familiar all surgeons. Data procedures unique issues compared studies involving systemic or radiation therapy. medical records related drug administration therapy well established often entered redundant manner, making this information readily accessible. Events occurring during surgery, however, transient, generally nonredundant. If dictated operative note, simply becomes unavailable documentation. Completeness accuracy entry just analysis actual performance procedure. A training quality-control program focused both methods recording completely. goals insure performed surgery according specific guidelines used protocol, pathologists evaluation listed documents appropriately generated, completely recorded pathology forms. Source defined trial-relevant present permanent legal record. An element core across country site visits participating centers. provided personal quality SNB, generation documentation, entry. standardize training, each trainer accompanied his her visit either PI (Krag) protocol Training Chair (Harlow). manuscript initial presentation process.