Press release 26 September 2024
A new study published in the Journal of Surgical Oncology (August 9 2024) demonstrates that an implantable catheter system developed by Combat Medical facilitates optimal chemotherapy recirculation and maintains its functionality, without complications, in long-term intraperitoneal use.
Intraperitoneal chemotherapy can be administered in successive doses under normothermic conditions. However, catheter-related complications – including infection, device obstruction, retractions, drug leakage, pain and intestinal perforation – can develop over long periods. [1,2,3] These result in up to one-third of patients abandoning treatment. [4,5]
To date, implantable peritoneal access devices have not eliminated these problems. The study’s authors suggested that the risk of infections and adhesions could be increased because the drug is not recovered after treatment, potentially generating an inflammatory response.
To address these concerns, the new implantable, silicone catheter was developed for use with Combat’s normothermic intraperitoneal chemotherapy (NIPEC) recirculation equipment and its disposable NIPEC recirculation kit. Based on Combat’s recirculating hyperthermic intraperitoneal chemotherapy (HIPEC) system, this enables normothermic recirculation of fluids in the peritoneal cavity at a specific and controlled flow, pressure and temperature. It also facilitates abdominal filling using an air purge, emptying of the cavity, and complete recovery of the drug within a closed and safe system at the end of the treatment.
No complications were observed in an experimental swine model (n=16), and optimal recirculation at low flow was achieved, both immediately after the first procedure and also after a second procedure either one or two weeks later. In five of the animals, a catheter replacement procedure was performed, confirming that optimal recirculation was maintained after the replacement. All the animals behaved normally, displaying no signs of pain and maintaining adequate food and water intake.
Combat Medical CEO Edward Bruce-White commented: “Our new catheter system shows promise for long-term intraperitoneal access and may facilitate compliance with long-term chemotherapy administration. It integrates the advantages of previous devices, including the fast and easy repositioning or replacement of central venous catheters using minimally invasive techniques. It also incorporates the benefits of peritoneal dialysis devices, which reduce complications such as infection, migration and leakage.
“Furthermore, its ability to recirculate and withdraw the chemotherapy drug at the end of treatment, as per HIPEC, allows for greater dynamic distribution of the drug and control over the duration of the chemotherapy’s action. The next step will be to confirm its safety and efficacy in patients through its use in a clinical trial, which is due to start in Spain shortly.”
The catheter incorporates a proximal balloon fixation, an irrigation line, a multi-perforated coaxial suction line with a specific anti-collapse design, a valved low-profile connector, a radio-opaque line and a distal tungsten ballast to maintain correct positioning within the cavity.
For more details, contact:
Guy Cooper, Sales and Marketing Director, Combat Medical
Email: grc@combat-medical.com
References
1. Helm C. Ports and complications for intraperitoneal chemotherapy delivery. BJOG Int Obstetric Gynaecol. 2012;119(2):150-159.
2. Kimyon Comert G et al. Management of catheter‐related complications during intraperitoneal chemotherapy for ovarian cancer: two case reports and review of the literature. Marmara Med J. 2018;31(2):88‐93.
3. Makhija S et al. Complications associated with intraperitoneal chemotherapy catheters. Gynecol Oncol. 2001;81(1): 77‐81.
4. Walker JL et al. Intraperitoneal catheter outcomes in a phase III trial of intravenous versus intraperitoneal chemotherapy in optimal stage III ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study. Gynecol Oncol. 2006;100(1):27‐32.
5. Lesnock JL et al. Completion of intraperitoneal chemotherapy in advanced ovarian cancer and catheter‐related complications. Gynecol Oncol. 2010;116(3):345‐350.
