MLC45FU study

JRCT ID: jRCTs042230058

Registered date:11/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cancer patients
• Date of first enrollment: 25/07/2023
• Target sample size: 61
• Study type: Interventional
• Intervention(s): After obtaining written informed consent, the midline catheter is inserted in the ward. A VYGON Arterial Leadercath catheter (8 cm) is used. The vein in the upper arm is visualized by echo or other means, and the catheter is punctured under echo guidance. If the guide wire can be inserted smoothly, the needle is removed and the catheter is inserted through the guide wire. Continuous 5-FU is administered through the inserted catheter.

Outcome(s)

• Primary Outcome: Incidence of Phlebitis in Continuous Intravenous 5-FU Infusion via Midline Catheter

Secondary Outcome

Success rate of midline catheter insertion
Incidence of adverse events due to insertion and placement of midline catheters
Injection site evaluation by patient (PRO-CTCAE&trade Japanese version 1.0)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with cancer who will receive continuous intravenous 5-FU infusion for at least 4 days in the hospital.
(2) Patients must be at least 18 years of age (at the time of signing the consent form).
(3) Performance status (PS) of 0 to 1 at the time of enrollment.
(4) Patients who have been fully informed of the study and who have given written consent of their own free will.

Exclude criteria

(1) Patients with any of the following complications.
1) Myocardial infarction
2) Congestive heart failure
3) Angina pectoris with subjective symptoms
4) Arrhythmia with subjective symptoms
5) Infection of skin or subcutaneous tissue of bilateral upper arms (e.g.cellulitis)
6) Burns or ulcers on both upper arms
(2)Patients with any of the following conditions.
1) Median nerve palsy or ulnar nerve palsy
2) Cerebral infarciton or hemiplegia requiring puncture insertion from the paralyzed side
3) Puncture insertion from the shunt limb or the limb from which the shunt is to be created is necessary
4) Puncture insertion from the limb from which the skin valve is to be extracted is required
5) Puncture insertion from the upper arm side with axillary lymph node dissection is necessary
(3) Patients with serious complications (interstitial pneumonia,pulmonary fibrosis,uncontrolled hypertension,uncontrolled diabetes,etc.)
(4) Patients with serious infections.
(5) Patients with dementia or other conditions that make it difficult to hold the catheter after insertion
(6) Patients whose bilateral brachial veins (ulnar vein and brachial vein) are anatomically difficult to insert catheters due to narrowness,collapse,thrombus occlusion,proximity to peripheral nerves,etc.
(7) Patients who have bilateral upper extremity range of motion impairment, such as strong contractures of the bilateral upper extremities.
(8) The most recent laboratory test results prior to enrollment are as follows.
1) Coagulation system factor PT(prothrombin time) 50% or less or INR(international normalized ratio)1.5 or more.
2) Platelet count less than 50,000mm3
(9) Patients who are taking more than 2 antithrombotic drugs.
(10) Pregnant or possibly pregnant.
(11) Other conditions that the investigator deems inappropriate for the safe conduct of this study.

Related Information

• Primary Sponsor: Taniguchi Hiroya