Safe and speedy way to treat gastrointestinal diseases
Millions of people around the world suffer from gastrointestinal diseases (GIs), such as irritable bowel syndrome, constipation, anal fissures and colon cancer. It is hard to pin down the exact economic cost of GIs, yet they lead to frequent medical visits, including high rates of hospitalisation. Absence from work and reduced productivity all compound the economic effects of the diseases. In many cases, disorders can often lead to a narrowing (stenosis) in the ducts of the pancreas and other organs. These situations require urgent treatment to restore proper drainage and prevent further complications like jaundice and liver disease. At present, these are treated through long-term placement of a stent – a metal or plastic tube inserted into the ducts. Yet this procedure, especially when multiple stent insertions are required, can lead to damaging side effects. “Placing stents in the liver and pancreas is critical to keeping pre-surgical patients stable. But these surgeries are tedious because, as things stand, the surgeon needs to re-navigate to the bile duct using a guidewire for each stent placement,” says Omri Naveh, CEO of Endo GI Medical and ENDOGI project coordinator. Multiple stents require multiple entries, taking up time for doctor and patient. Lost guidewires are also commonplace.
A smarter stent solution
The EndoGI system was created with the help of Horizon 2020 funding, to speed up the process and reduce harmful effects of the regular treatment pattern. The team designed and created the first patented, multi-stent delivery system for the treatment of stenosis in ducts around the liver, urinary tract and pancreas. The system is capable of inserting one or two plastic stents with a single guidewire. It also allows for secure, constant access to the guidewire throughout the procedure. The speed that this allows decreases the adverse effects from prolonged operation time. Extended operation times in the treatment of GIs can lead to heart problems, such as myocardial injury. Just 15 minutes of prolonged operation time has been shown to increase the risk of myocardial ischemia, where reduced blood flow to the heart means it cannot get enough oxygen, by up to 141 %. Plastic stents are cheaper than metal ones, and easier to remove. The ability to place multiple stents in parallel has a wide range of benefits: a larger overall drainage diameter in the chosen duct improves treatment outcome; the enhanced outward force resists compression pressure; and the risk of stent migration is lowered.
From pigs to humans
Positive tests of the system have been carried out on pigs. Pilot studies in humans will soon be carried out in both the EU and US, after which the team hopes to secure complete regulatory approvals. Substantial roundtable interviews and in-depth questionnaires among physicians in both regions have shown the device to be popular and to have a wide appeal among medical practitioners. The grant from the European Commission supported the team in carrying out research to better understand the market need, and how to manage the research and development processes. As a result, the treatment should arrive sooner than would have been possible. “We have paved the way to becoming available to the market in a short period,” says Naveh.
Keywords
ENDOGI, gastrointestinal disease, treatment, pain, side effect, stent, multiple, plastic, cheaper