Medical Devices: Evidence and Research (Mar 2009)

Intra-arterial hepatic chemotherapy for unresectable colorectal liver metastases: a review of medical devices complications in 3172 patients

  • Stefano Bacchetti,
  • Enricomaria Pasqual,
  • Elena Crozzolo,
  • Alessandra Pellarin,
  • Pier Paolo Cagol

Journal volume & issue
Vol. 2009, no. default
pp. 31 – 40

Abstract

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Stefano Bacchetti, Enricomaria Pasqual, Elena Crozzolo, Alessandra Pellarin, Pier Paolo CagolDepartment of Surgical Sciences, Faculty of Medicine and Surgery, University of Udine, ItalyBackground: Hepatic artery infusion (HAI) is indicated to treat unresectable colorectal hepatic metastases, with recent applications as a neoadjuvant or adjuvant treatment. Traditionally performed with the infusion of fluoropyrimidine-based chemotherapy, it has been now tested with oxaliplatin or irinotecan and associated with systemic chemotherapy.Methods: To evaluate the impact of medical devices complications we carried out a search of the published studies on HAI in unresectable colorectal liver metastases. Complications were pooled according to the applied medical system: 1) surgical catheter, 2) radiological catheter, and 3) fully implantable pump. The surgical catheter is inserted into the hepatic artery from the gastro-duodenal artery. The radiological catheter is inserted into the hepatic artery through a percutaneous transfemoral or transaxillar access. The fully implantable pump is a totally internal medical device connected to the arterial hepatic catheter during laparotomy.Results: The selection criteria were met in 47/319 studies. The complications of surgical and radiological medical devices connected to a port were found in 16 and 14 studies respectively. Meanwhile, complications with a fully implantable pump were reported in 17 studies. The total number of complications reported in studies evaluating patients with surgical or radiological catheter were 322 (322/948, 34%) and 261 (261/722, 36.1%) respectively. In studies evaluating patients with a fully implantable pump, the total number of complications was 237 (237/1502, 15.8%). In 18/319 studies the number of cycles was reported. The median number of cycles with surgically and radiologically implanted catheters was 8 and 6 respectively. The fully implantable pump allows a median number of 12 cycles.Conclusions: The fully implantable pump, maintaining a continuous infusion through the system, allows the lowest risk for thrombosis and infection and the best median number of cycles of loco-regional chemotherapy in HAI.Keywords: liver metastases, colorectal cancer, medical devices, loco-regional treatments, intra-arterial hepatic chemotherapy