Medical thoracoscopy with talc poudrage and indwelling pleural catheter insertion versus medical thoracoscopy with talc poudrage alone for patients with symptomatic malignant pleural effusion (TACTIC): a randomised, controlled phase 3 trial.

Therapeutic options include talc pleurodesis via chest drain, poudrage during medical thoracoscopy, or alternatively an indwelling pleural catheter (IPC).

治疗方案包括通过胸管进行滑石粉胸膜固定术、医疗胸腔镜下的粉末喷洒术，或者选择植入式胸膜导管（IPC）。

Combining the diagnostic and therapeutic efficacy of medical thoracoscopy and poudrage with the ambulatory benefits of an IPC has not been studied within a randomised controlled trial. The aim of the TACTIC trial was to determine whether this approach resulted in a reduced length of hospital stay and improvements in dyspnoea.

将内科胸腔镜和粉末喷洒的诊断和治疗效果与间皮导管（IPC）的门诊益处相结合的研究尚未在随机对照试验中进行。TACTIC试验的目的是确定这种方法是否导致住院时间缩短和呼吸困难的改善。

Methods

This unblinded, phase 3, randomised controlled trialwas undertaken in 11 UK hospitals.

这项单盲、第三阶段的随机对照试验在英国的11家医院进行。

Patients with MPE and confirmed malignancy (during medical thoracoscopy or beforehand) received talc poudrage and were randomly assigned by a centralised web-based system to an IPC at the time of medical thoracoscopy or usual care (ie, medical thoracoscopy, poudrage, and admission with large bore tube).

确诊为恶性胸腔积液（MPE）的患者（在内科胸腔镜检查期间或之前）接受了滑石粉喷洒，并通过一个集中的基于网络的系统随机分配到在内科胸腔镜检查时放置胸腔间皮导管（IPC）组或常规护理组（即内科胸腔镜检查、喷洒滑石粉和使用大口径管进行住院）。

Co-primary outcomes were time in hospital (including initial admission for trial procedure and any subsequent readmissions over 4 weeks post procedure) and average breathlessness assessed with visual analogue scale dyspnoea scores, measuring severity of dyspnoea from 0 mm to 100 mm, over a 4-week period.

主要共研究结果是住院时间（包括试验程序的初始入院和术后4周内的任何后续再入院）和平均呼吸困难程度，通过视觉模拟量表（VAS）呼吸困难评分在4周内测量，评分范围从0毫米到100毫米。

All randomised patients in whom an outcome was available were included in the analysis on a modified intention-to-treatbasis.

所有随机患者中，有结果可查的患者均基于修改后的意向治疗原则纳入分析。

TACTIC was registered with ISRCTN on Aug 8, 2021 (ISRCTN11058680).

TACTIC于2021年8月8日在ISRCTN注册（ISRCTN11058680）。

Results

Participants were recruited from between Dec 15, 2021, and Jan 3, 2024. 124 participants were randomised: 62 to the intervention and 62 to standard care.

参与者招募时间为2021年12月15日至2024年1月3日。共有124名参与者被随机分配：62名接受干预措施，62名接受标准护理。

Leading diagnoses were pleural mesothelioma (46%), lung cancer (28%), and breast cancer (10%).

主要诊断为胸膜间皮瘤（46%）、肺癌（28%）和乳腺癌（10%）。

Co-primary outcome data were available for 102 patients for total length of hospital stay (52 in intervention group vs 50 in standard care group) and 108 patients for breathlessness (57 vs 51).

共102名患者的共同主要结局数据可用于总住院时间（干预组52例对比标准护理组50例），以及108名患者的呼吸困难数据（干预组57例对比标准护理组51例）。

Median time in hospital was 1 day (IQR 1-3, 95% CI 1-2) in the intervention group versus 2 days (IQR 1-3, 95% CI 1-2) in standard care group (p=0·26).

干预组的中位住院时间为1天（四分位数间距1-3天，95%置信区间1-2天），标准护理组为2天（四分位数间距1-3天，95%置信区间1-2天），P值为0.26，差异无统计学意义。

Median visual analogue scale dyspnoea scores did not differ between groups: 14·0 mm (IQR 8·8-32·4) in the intervention group versus 19·6 mm (8·1-38·7) in standard care group (p=0·26).

两组之间的中位视觉模拟量表呼吸困难评分没有差异：干预组为14.0毫米（四分位数间距8.8-32.4毫米），标准护理组为19.6毫米（四分位数间距8.1-38.7毫米）（p=0.26）。

Participants in the intervention group required fewer additional invasive pleural procedures by 12 weeks (two [3%] of 60 vs 19 [34%] of 56, p<0·0001) Trial related adverse events rates were similar in both groups (46 [74%] of 62 vs 44 [71%] of 62, p=0·84).

到12周时，干预组需要的额外侵入性胸膜操作较少（60人中有2人[3%]，而56人中有19人[34%]，p<0.0001）。试验相关的不良事件发生率在两组中相似（62人中有46人[74%]，与62人中有44人[71%]，p=0.84）。

Three related serious adverse events were recorded, all occurring in the intervention group.

记录了三起相关的严重不良事件，均发生在干预组。

interpretation

The combination of medical thoracoscopy, poudrage, and IPC did not result in shorter hospital stay but was safe and resulted in similar dyspnoea control compared with standard care.

结合内科胸腔镜、粉末喷洒和间皮腔内导管（IPC）的治疗方法并没有缩短住院时间，但其安全且与标准治疗相比，对呼吸困难的控制效果相似。

For patients with symptomatic MPE undergoing medical thoracoscopy for pleurodesis who prioritise minimising the length of hospital stay or the need for further invasive pleural procedures, the addition of an IPC alongside poudrage might help to achieve this goal.

对于接受内科胸腔镜进行粘连治疗的有症状性恶性胸腔积液患者，如果他们优先考虑缩短住院时间或减少进一步侵入性胸膜程序的需求，那么在粉末喷洒的同时添加间皮导管可能会帮助实现这一目标。

funding

National Institute of Health Research, Research for Patient Benefit.

国家卫生研究院，患者利益研究。