None listed
Conditions
Brief summary
A randomised study of a temporary placed catheter for serial intermittent use versus a permanent placed indwelling catheter (Rocket 'Registered Trademark') for continuous drainage of malignant ascites in cancer patients. This study will investigate the acceptability and safety of an indwelling catheter for patients with cancer.
Interventions
Arm A: Temporary placed catheter for recurrent large volume drainage (current best practice) Arm B: Permanent placed indwelling catheter (Rocket 'Registered Trademark') for intermittent drainage (treatment group). Operators / Interventional Radiologists restricted to two very experienced radiolkogists are to wear head, face and shoe coverings. All access to the room will be restricted to the team performing the procedure. Patients are to be nil by mouth for 6 hours before the procedure (water with medication allowed). Patients may receive conscious sedation with IV midazolam (1 mg) and IV fentanyl (50 mcg). This will be adjusted as required due to patient discomfort, anxiety and body habitus and previous opiate exposure. There will be prophylactic pre-procedure antibiotic coverage for skin flora with IV cefazolin 1g will also be administered. An appropriate alternative will be provided for people who have a Cephalosporin allergy. Radiologic Technique: Sonography will be performed before the surgical scrub to localise of a large pocket of ascites. Lateral location for initial access is preferred to facilitate a medially directed subcutaneous tunnel. This allows the exit site of the catheter to be close to midline, allowing a convenient place for access. The Rocket Indwelling Abdominal Catheter will be placed as per the product instructions for use. All the equipment needed for placement is included in the Kit. The site is selected and the patient is prepped. The surgical field will be prepared with providone iodine solution. The operative field will then be draped. The skin of the insertion site and tunnel will be infiltrated with local anaesthetic. A small incision is then made at the insertion site and the tunnel exit site. Under ultrasound guidance the 18g needle will be inserted into the peritoneal cavity and aspiration performed to confirm position. The guide-wire will then be inserted through the needle and the needle removed leaving the guide wire in-situ. The IAC would then be tunnelled (antegrade) using the pre-attached tunnelling device and then drawn through until the cuff is mid-way along the tunnel. The 16g tear way sheath will be then inserted over the guide wire into the peritoneal cavity. The catheter detached from its tunneller and inserted through the sheath which is then torn away and removed. The catheter will then be withdrawn until the cuff is one centimetre from the outer end of the tunnel. The primary insertion site and the tunnel exit are then closed and the site is dressed. The included drainage bag would then be attached to the catheter and the ascites allowed to drain freely. Approximately 90 minutes for the pre and post procedure within interventional radiology, with an additional 6 hours post op follow up within oncology acutes. The catheter will remain in-situ until death, or removed for an adverse event removal, or at patients request. Weekly visits to patient home will be carried out by the Research Nurse. Abdomen will be assessed for ascites, if present will be drained up to a maxim of 2L. Weekly visits will include an assessment of the insertion site for infection, drainage problems ie occlusion and leakage from the insertion site. All results will be recorded and tabled in the results on frequency of each problem.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Patients greater than or equal to 18 years old 2. Histologically confirmed cancer (Histological or cytological specimens must be collected via surgical biopsy, brushing, washing or core needle aspiration of a defined lesion) 3. Patients should be aware of the diagnosis of cancer and that there are no further systemic anti-cancer treatment options open to them 4. Patients diagnosed with cancer of ovarian (or related), gastrointestinal or breast cancer 5. Patients able to give written informed consent obtained according to local guidelines 6. Fulfils at least Grade 2 or 3 International Ascites Club criteria and are symptomatic. (Grade 2: moderate ascites with moderate symmetrical distension of the abdomen and Grade 3: large or gross ascites with marked abdominal distension). Patients should have greater than or equal to grade 2 ascites. 7. Karnofsky Score greater than or equal to 60 OR ECOG Performance Status 0, 1, 2 or 3 8. Requires two therapeutic paracentesis within the last 30 days and been paracentesis-free for the last seven days. 9. Patients with systolic BP greater than or equal to 100 mmHG or diastolic greater than or equal to 60 mm HG 10. Lab values within the range as defined below, on day of randomisation Absolute neutrophils count (ANC) greater than or equal to 1.5 x 109/L Platelets greater than or equal to 100 x 109/L Haemoglobin greater than or equal to 90 g/dL INR greater than or equal to 1.3 Serum creatinine less than or equal to 1.5 x ULN Serum bilirubin ULN and both Aspartate transaminase (AST) and Alanine transaminase less than or equal to 5 x ULN 11. Life expectancy greater than or equal to 3 months
Exclusion criteria
1. Patient unwilling or unable to comply with the study protocol 2. Patients with a stoma 3. Patients receiving enteral feeding 4. Concurrent severe and / or uncontrolled medical disease (e.g. uncontrolled diabetes) 5. Infection e.g. peritoneal cavity 6.History of liver disease with chronic cirrhosis 7. Planned intravenous, oral or intraperitoneal chemotherapy or immunotherapy and active treatment in the last 21 days.