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
Abstract
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