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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042240197
Enrollment
20
Registered
2025-02-27
Start date
2025-04-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 t

Sponsors

Hamauchi Satoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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

Contacts

Public ContactYuuichi Hashimoto

Shizuoka Cancer Center

y.hashimoto@scchr.jp+81-55-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026