Biffi 2009.
| Methods | ‐Country: Italy
‐Setting: European Institute of Oncology in Milan (operating room or angiographic suite) ‐Study design: RCT |
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| Participants | ‐No. of participants randomised: 403
‐Exclusions post randomisation: 2 cancelled operations in the internal jugular catheter group ‐Shifted to another arm: 12 in the internal jugular catheter group, 1 in the subclavian catheter group, and 21 in the cephalic catheter group ‐Number of participants evaluated: data for late complications evaluated for 360 participants ‐Age (mean): 52 years ‐Gender: 90 males, 313 females ‐Inclusion criteria: Hospitalised adults (aged 18 to 75), with an Eastern Cooperative Oncology Group performance status of 0 to 2, bearing solid tumours and candidate for intravenous chemotherapy ‐Exclusion criteria: Active infections, coagulopathy (defined as platelet count < 50,000/µL and/or prothrombin time > 18 s), life expectancy < 6 months, or inability to give written informed consent |
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| Interventions | ‐A total of 403 participants were randomly assigned to undergo implantation of TIVAP through a percutaneous landmark access to internal jugular vein (n = 134), US‐guided infraclavicular access to subclavian vein (n = 136), or a surgical cutdown access through the cephalic vein (n = 133) ‐No mention of procedure fluoroscopy, however chest radiograph was obtained after each procedure |
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| Outcomes | ‐Failure of catheter placement ‐Duration of TIVAP ‐Early complication (intraoperative and post implantation period to first use) ‐Late complications (occurring after first chemotherapy course given through the device) |
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| Notes | TIVAP: single type of port, constructed of titanium and silicone rubber, with a attached 6‐F polyurethane catheter tubing (BardPort; Bard Access Systems Inc, Salt Lake City, UT, USA) Only oncology patients |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "computer‐assisted procedure" |
| Allocation concealment (selection bias) | Unclear risk | "Randomization was intraoperatively carried out by the data manager of the trial using a computer‐assisted procedure and communicated to the operators." It is unclear if the data manager was blinded |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding of either participants or personnel mentioned in the methodology. Comment: Blinding of personnel carrying out the procedure is not feasible for this procedure. Blinding of participants, however, is practically feasible. Nevertheless, it is unlikely the blinding of the personnel and participants would have affected the outcomes of the study. We judged performance bias as low risk of bias |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses to follow‐up: 2 withdrew informed consent and 13 had no data available in the internal jugular vein group; 1 withdrew informed consent and 12 had no data available in the subclavian catheter group; 2 withdrew informed consent and 11 had no data available in the cephalic catheter group. Data on late complication only reported in the on‐treatment group. No ITT analysis |
| Selective reporting (reporting bias) | Low risk | All outcomes reported; flowchart provided |
| Other bias | Low risk | Funding from Italian Association for Cancer Research No mention of author conflict of interest |