Petitoneal catheter placement and space-making radiotherapy with artificial ascites for abdominal or pelvic malignant tumors

Clinical study of safety and efficacy of peritoneal catheter placement and saline injection as artificial ascites for space-making radiotherapy in patient with abdominal or pelvic malignant tumor

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042210139

Enrollment

Registered

2022-02-02

Start date

2022-10-12

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

abdominal or pelvic malignant tumors

Interventions

External beam irradiation, percutaneus cacheter insersion, catheter placement into peritoneum cavity or extraperitoneal space , Saline injection at simulation and each treatment session

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically or clinically confirmed primary or metastatic malignant tumors (carcinoma or sarcoma) located in the abdomen and pelvis. (2) The presence of a bowel within a 10 mm distance from GTV (3) ability to maintain a prone or supeine position during radiotherapy (4) Age of 18 years or older (5) Eastern Cooperative Oncology Group performance status 0, 1, and 2 (6) prognosis of > 6 months, based on New Katagiri score (7) provision of written informed consent

Exclusion criteria

Exclusion criteria: (1) Patients who potentially have severe tissue adhesion in the area where catheter will be placed (2) Patients with disseminated metastasis of the peritoneum detected by cytology or radiography in the area of catheter insertion and/or placemen (3) patients with radiation-sensitive tumors, including malignant lymphoma, myeloma, or germ cell tumor (4) Platelet count<50,000 / mm3 (5 ) 1. Heart disease, hypertension, diabetes, psychiatric disease, seizure and seizure disease, intractable infectious disease whose medical treatment is difficult to control. 2. Patients who take antiplatelet drugs ,anticoagulants, and is difficult to discontinue them (6)Woman who is pregnant , lactating or wishing to have children (7)Patient who is deemed inappropriate by the doctor due to medical or psychological factors

Design outcomes

Primary

Measure	Time frame
Phase I part: Morbidity (Rate of toxicity greater than grade IIIb which is obviously attributed to percutaneous catheter insertion and placement) Phase II part: Succeful rate (Rate of the distance between bowel and GTV of at least 10-mm distance at Simulation)	—

Secondary

Measure	Time frame
(1)The shortest distance between bowel and GTV at each radiation therapy session (2)Dosimetric outcomes (PTV,Bowel) (3)all adverse events during radiation therapy (4)Severe adverse events until the 10th week after the end of radiation therapy	—

Contacts

Public ContactTsuyoshi Onoe

Shizuoka Cancer Center

t.onoe@scchr.jp+81-55-989-5222

Outcome results

None listed

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