A Randomized, Double Blinded, Controlled Trial of a Rapid Pleurodesis Protocol After Indwelling Pleural Catheter Placement for Malignant Pleural Effusions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Time to catheter removal
研究概览
简要总结
The primary objective of the study is to evaluate whether the use of a rapid pleurodesis protocol using 10% iodopovidone immediately after tunneled pleural catheter placement improves time to IPC removal compared to patients who receive an IPC alone.
详细描述
Patients will be screened throughout the year as part of the clinical referral process to the Interventional Pulmonology service at the Hospital of the University of Pennsylvania for the management of a malignant pleural effusion. Patients eligible for inclusion based on the clinical evaluation will be approached for enrollment. Written consent will be obtained. Patients will subsequently undergo placement of a IPC under MAC as per standard clinical practice followed by complete drainage of the pleural space. Patients randomized to the rapid pleurodesis protocol arm will received 20mL of 10% iodopovidone mixed with 80mL of normal saline instilled intrapleurally through the IPC. Patients randomized to the standard of care arm will have 100mL of normal saline (placebo) instilled intrapleurally through the IPC. The mixture will be allowed to dwell for 2 hours and then completely evacuated through the IPC and the patient will be discharged home.
After discharge, all patients will continue to drain their IPC on a daily basis for 7 days. Following this, all patients will continue to drain their IPC on an every-other-day basis until total IPC output is less than 50ml per session over 3 consecutive sessions. At which point they will be asked to undergo a clamp trial of no drainage for 7 days followed by a reattempt at drainage. Patients without return of symptoms over those 7 days and minimal drainage afterwards (<50ml) will be seen in the office for possible IPC removal. Patients with return of symptoms during those 7 days or more than minimal drainage afterwards (>50mL) will be asked to continue drainage until total IPC output is again less than 50mL per session over 3 sessions.
After a passed clamp trial, patients will be evaluated in the office with a bedside ultrasound to assess for pleural apposition in 5 of 6 designated points and the absence of pleural effusions. If all criteria are met, the IPC is removed. If there is evidence of residual effusion, continued drainage will be advised.
All patients will be evaluated in the office on day 7, day 14, day 30, day 60 and day 90 after IPC placement. On each visit they will be assessed for pleural apposition with ultrasound. At day 30, 60, and 90 all patients will receive a global health related questionnaire (EORTC QLQ30) and a symptom questionnaire. At 90 days, complications rate will be assessed for the entire study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Subject assignment will be done using randomly generated assignment tables based on stratification by tumor type (Lung, Breast, Other) and assigned 1:1 using random permuted blocks of 4.
Subjects will be blinded to their group assignment to minimize bias on follow up surveys.
Physicians evaluating the patient during the initial visit and on subsequent postprocedure followup will be blinded to subject assignment. The provider responsible for placement of the catheter and delivery of the pleurodesis agent or placebo will not be involved in post procedure followup care
All treatment physicians will follow prespecified protocols in deciding on adequate pleurodesis and timing of IPC removal.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MPE as defined by
- •A diagnosis a pleural effusion in the setting of known malignancy. AND
- •Confirmed malignant involvement of the pleural space by fluid cytology or pleural biopsy. OR
- •Evidence of pleural disease on radiographic imaging. OR
- •A recurrent effusion with no other identifiable cause after thorough workup.
- •Symptomatic from the pleural effusions (shortness of breath, cough, or chest pain)
- •Prior thoracentesis with post procedure symptomatic relief
- •Recurrence of symptoms with re-accumulation of pleural effusion
- •Lung re-expansion after thoracentesis on chest imaging within last 30 days
排除标准
- •Malignant pleural effusion due to a hematologic malignancy
- •Any history of trapped lung
- •Prior attempted pleurodesis on the affected site
- •Pregnant or lactating
- •Known allergy to iodopovidone (Betadine)
- •Unable or unwilling to provide consent
- •Uncorrectable coagulopathy (INR > 1.5, aPTT > 1.5 x the upper limit of normal) or thrombocytopenia (< 50,000)
- •Anatomic contraindication to IPC (overlying skin abnormalities)
- •Unable or unwilling to care for IPC and adhere to drainage protocol
- •Need for bilateral IPC placement
研究组 & 干预措施
Standard of care
Subjects in this arm will receive placebo only (100mL of normal saline) into the pleural space delivered via the newly placed tunneled intrapleural catheter
干预措施: Placebo (Other)
Rapid pleurodesis protocol
Subjects in this arm will receive the chemical pleurodesing agent of 10% iodopovidone solution delivered to the pleural space via the newly placed tunneled intrapleural catheter
干预措施: Rapid pleurodesis protocol (Drug)
结局指标
主要结局
Time to catheter removal
时间窗: 90 days
Time to IPC removal will be measured in days from the day of IPC placement to the day of IPC removal after meeting removal criteria as listed above.
次要结局
- Change in Global Health Related Quality of Life(30 days, 60 days, and 90 days after catheter placement)
- Change in symptoms of pain and breathlessness(30 days, 60 days, and 90 days after catheter placement)
- Time to return of clinically significant pleural effusion(90 days)
- Rate of successful pleurodesis at 90 days(90 days)
研究者
Kevin Ma, MD
Assistant Professor of Clinical Medicine
University of Pennsylvania