jRCTs042240197招募中不适用
An Exploratory study of a new drainage catheter fixation device for solid cancer patients with pleural, ascites, or pericardial effusion
未提供0 个研究点目标入组 20 人开始时间: 2025年4月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 主要终点
- Percentage of patients who were able to remain in a fixation device for 1 week without complete catheter deviation or complete detachment of the fixation device from the body surface
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Ascites: Patients with solid cancer who are considered to require drainage more than once a week on the ward and for whom indwelling catheters may be useful.
- •Pericardial effusion: Patients with solid tumors who are considered to require continuous drainage for more than 1 week in the ward.
- •Pleural effusion: Patients who are considered to require continuous drainage for more than 1 week in the ward. Pleural effusion: Patients with solid cancer who are considered to require continuous drainage for more than 1 week in the ward or drainage more than once/week and for whom catheter placement is considered useful.
- •The following are common selection criteria
- •Patients who can stay in the hospital for at least 1 week (drainage days 1-8)
- •Patients with a drainage catheter of 12Fr or less to be inserted
- •Prognosis is expected to be more than 1 month
- •Patients who are at least 18 years old at the time of consent
- •Patients have given written consent to participate in the study. However, even if the patient is able to understand and agree to the content of the explanation, if the patient is unable to sign the informed consent form due to worsening of systemic symptoms, a surrogate may sign on behalf of the patient to confirm the patient's consent.
排除标准
- •Patients who are unable to comply with instructions
- •Patients who require drainage in more than one location at the same time
- •Patients who have an uneven surface due to ribs, etc., at the location where the fixation seal is applied, which may make stable fixation difficult.
- •Patients who are expected to have skin problems after fixation due to skin diseases or fragility of the skin
- •Patients with psychiatric disorders or psychiatric symptoms that interfere with their daily life and make it difficult for them to participate in the study
- •Other patients who are deemed inappropriate to participate in the study by the principal investigator or sub-investigator.
结局指标
主要结局
Percentage of patients who were able to remain in a fixation device for 1 week without complete catheter deviation or complete detachment of the fixation device from the body surface
时间窗: 1 week
Definition of complete catheter deviation : catheter deviates from the body surface in its entirety, or even one of the catheter's side holes is visible from the body surface.
次要结局
- Degree of catheter deviation
- Degree of detachment of the fixture from the body surface
- Degree of side leakage around the fixture
- Whether or not there are skin problems at the time of completion or discontinuation of the procedure
- Degree of itching around the fixation device
- Degree of pressure sensation around the fixation device
- The degree of hindrance to daily life caused by the fixture
研究者
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