Bajwa Mandeep S, Jackson Richard, Dhanda Jagtar, Tudur Smith Catrin, Shaw Richard J, Schache Andrew G
Liverpool Head & Neck Centre, Department of Molecular and Clinical Cancer Medicine, The University of Liverpool, William Henry Duncan Building, 6 West Derby Street, Liverpool L7 8TX, UK.
Liverpool Clinical Trials Centre, The University of Liverpool, Liverpool L69 3BX, UK.
Cancers (Basel). 2023 Oct 20;15(20):5073. doi: 10.3390/cancers15205073.
High-quality randomised controlled trials (RCT) to support the use of Fibrin Sealants (FS) in neck dissection (ND) are lacking. The DEFeND trial assessed critical pilot/feasibility questions and signals from clinical outcomes to inform a future definitive trial.
The study design piloted was a blinded surgical RCT. All participants underwent unilateral ND for head and neck cancer. Interventional arm: ND with application of FS.
ND alone. Feasibility outcomes included recruitment, effectiveness of blinding, protocol adherence and evaluating administrative processes. Clinical outcomes included surgical complications (primary outcome), drainage volume, time to drain removal, length of hospital stay, pain and the Neck Dissection Impairment Index.
Recruitment completed ahead of time. Fifty-three patients were recruited, and 48 were randomised at a rate of 5.3 patients/month. Blinding of patients, research nurses and outcome assessors was effective. Two protocol deviations occurred. Two patients were lost to follow-up. The mean (SD) Comprehensive Complication Index in the interventional arm was 6.5 (12.8), and it was 9.9 (14.2) in the control arm. The median (IQR) time to drain removal (days) was shorter in the interventional arm (2.67 (2.42, 3.58) vs. 3.40 (2.50, 4.27)). However, this did not translate to a clinically significant reduction in median (IQR) length of hospital stay in days (intervention: 3.48 (2.64, 4.54), control: 3.74 (3.11, 4.62)).
The proposed trial design was effective, and a definitive surgical trial is feasible. Whilst there was a tendency for FS to improve clinical outcomes, the effect size did not reach clinical or statistical significance. (ISRCTN99181100).
缺乏高质量的随机对照试验（RCT）来支持在颈部清扫术（ND）中使用纤维蛋白封闭剂（FS）。DEFeND试验评估了关键的先导/可行性问题以及临床结果的信号，以为未来的确定性试验提供信息。
所采用的研究设计是一项双盲手术随机对照试验。所有参与者均接受了单侧颈部清扫术以治疗头颈癌。干预组：在颈部清扫术中应用FS。
仅进行颈部清扫术。可行性结果包括招募情况、盲法的有效性、方案依从性以及行政流程评估。临床结果包括手术并发症（主要结果）、引流量、拔管时间、住院时间、疼痛以及颈部清扫损伤指数。
招募提前完成。共招募了53名患者，其中48名被随机分组，每月招募5.3名患者。患者、研究护士和结果评估者的盲法有效。发生了2次方案偏离。2名患者失访。干预组的平均（标准差）综合并发症指数为6.5（12.8），对照组为9.9（14.2）。干预组的拔管中位时间（天）（四分位间距）较短（2.67（2.42，3.58）对3.40（2.50，4.27））。然而，这并未转化为住院天数中位数（四分位间距）的临床显著减少（干预组：3.48（2.64，4.54），对照组：3.74（3.11，4.62））。
所提议的试验设计有效，确定性手术试验可行。虽然FS有改善临床结果的趋势，但效应大小未达到临床或统计学意义。（国际标准随机对照试验编号：ISRCTN99181100）
