Tokyo, March 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060927) titled 'A Study to Evaluate the Safety of Removing a Large Amount of Ascites at One Time in Patients with Cancer' on March 13.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Osaka medical and pharmaceutical university
Condition:
Condition - Cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the safety of paracentesis procedures aiming for large-volume ascites drainage exceeding 4 liters in patients with malignant ascites.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Paracentesis
Eligibility:
Age-lower limit - 18
years-old
= 6.0 g/dL
b). Platelet count >= 50,000/mm3
c). Creatinine level < 2.0 mg/dL
d). Total bilirubin level < 5.0 mg/dL
6 Written informed consent for study participation has been obtained from the subject.
Key exclusion criteria - 1 Received new chemotherapy (including molecularly targeted drugs) or immunotherapy within the past 3 weeks
2 Has active systemic or intraperitoneal infection
3 Has a systolic blood pressure below 100 mmHg
4 Has a psychiatric disorder or psychiatric symptoms that are judged to make participation in the study difficult
5 Other patients deemed unsuitable for inclusion by the principal investigator (or sub-investigator)
Target Size - 24
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 13 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068530
Disclaimer: Curated by HT Syndication.
