A phase I/II study of transjugular-transhepatic peritoneo-venous shunting for malignant ascites (JIVROSG-0201)

Phase 1

• Conditions: Cancer-related refractory ascites

• Registration Number: JPRN-C000000040
• Lead Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)

Brief Summary

Procedures were completed in all 33 cancer patients (PS 0 in 1, 1 in 11, 2 in 6 and 3 in 15). The right jugular vein was used in 28 pts for the access route, and the right HV was used in 32 pts for perforating route. The pressure gradient between SVC and AC was 17+/-6 cmH2O (mean +/- S.D). The required time was 53+/-30 min (mean +/- S.D). 8 patients died of primary disease progression within 30 days after the procedure. As the procedure related major adverse reaction (>/=Grade 2), decrease of serum albumin, decrease of hemoglobin, appearance of pleural effusion, skin inflammation around the catheter insertion site, congestive cardiac failure, reactive fever were observed in 7,6,3,3,1 and 1 case, respectively. Response rate was 67% (50-80% in 95% CI) (SE in 11, ME in 11 and NE in 11). In 7 among the responded pts, re-increase of ascites occurred over 10 days after the procedure presumed caused by fibrin sheath formation around the TTPVS catheter. Conclusion Newly developed TTPVS is safe and feasible procedure. And it may potentially replace the conventional shunt using subcutaneous lager tube to manage RA in cancer pts because of its lower invasion and efficacy. However, to achieve the better clinical outcome, the improvement of TTPVS catheter will be required.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-05
• Study Completion: 2007-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

1) Controllable ascites by standard anti-cancer therapies. 2) Intracavitary administration of anti-cancer agent is scheduled. 3) Controllable ascites by vascular interventions. 4) No symptom due to ascites. 5) Ascites due to malignatnt mesothelioma, mucin-producting tumor, pseudomyxoma. 6) Bloody, chylous or cloudy ascites. 7) Tumor or dilated intestine along the planned route for catheterization. 8) Active infection. 9) Untreated esophageal varices with red-color sign. 10) Active bleeding from upper digestive tract. 11) Post hepatic lobectomy. 12) Cardiac pacemaker. 13) Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events

Secondary Outcome Measures

Name	Time	Method
Improvement of symptom, decrease of ascites and body weight, elimination of diuretics.