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An Exploratory study of a new drainage catheter fixation device for solid cancer patients with pleural, ascites, or pericardial effusion

An Exploratory study of a new drainage catheter fixation device for solid cancer patients with pleural, ascites, or pericardial effusion

Hamauchi Satoshi

Shizuoka Cancer Center

1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

s.hamauchi@scchr.jp

Hashimoto Yuuichi

Shizuoka Cancer Center

1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

+81-55-989-5222

y.hashimoto@scchr.jp

Not Recruiting

Feb. 27, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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
1) Patients who can stay in the hospital for at least 1 week (drainage days 1-8)
2) Patients with a drainage catheter of 12Fr or less to be inserted
3) Prognosis is expected to be more than 1 month
4) Patients who are at least 18 years old at the time of consent
5) 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.

1) Patients who are unable to comply with instructions
2) Patients who require drainage in more than one location at the same time
3) 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.
4) Patients who are expected to have skin problems after fixation due to skin diseases or fragility of the skin
5) Patients with psychiatric disorders or psychiatric symptoms that interfere with their daily life and make it difficult for them to participate in the study
6) Other patients who are deemed inappropriate to participate in the study by the principal investigator or sub-investigator.

Both

Solid tumor patients with fluid retention requiring frequent drainage or continuous drainage

Placement of a new drainage catheter for 1 week in solid tumor patients with pleural/pericardial/ascites fluid who are considered to require continuous drainage for more than 1 week or drainage more than once/week

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.
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.

1) Degree of catheter deviation (evaluated on a 3-point scale: no deviation, partial deviation, and complete deviation)
2) Degree of detachment of the fixture from the body surface (evaluated in 4 levels: no detachment, detachment without additional treatment, detachment with additional treatment, and complete detachment).
(evaluated in 4 stages: no separation, separation with no additional treatment, separation with additional treatment, and complete separation)
3) Degree of side leakage around the fixture (evaluated in 3 levels: no side leakage, side leakage but no additional treatment required, side leakage and additional treatment required).
No side leakage, side leakage but no additional treatment required, side leakage and additional treatment required)
4) Whether the catheter position is adjusted by the physician or not.
5) Whether or not there are skin problems at the time of completion or discontinuation of the procedure (photographs should be taken).
6) Degree of itching around the fixation device (Patient's own rating on a 4-point categorical scale: not at all, a little, yes, and strongly)
7) Degree of pressure sensation around the fixation device (Patient's own rating on a 4-point categorical scale: not at all, a little, yes, and strongly)
8) The degree of hindrance to daily life caused by the fixture (Patient's own rating on a 4-point categorical scale: not at all, a little, a little, yes, and strongly)
9) Adverse events related to catheterization

+81-55-989-5222

Feb. 21, 2025

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