A new Hebrew University-developed procedure to identify bile ducts promises to greatly reduce the risk of what could be a fatal injury during one of the most common medical procedures.
CholeVision, a new system developed by researchers at Hebrew U’s BioDesign Medical Innovations program, will enable doctors to more easily identify bile ducts during gallbladder surgery, so they can avoid damaging them ducts and thus prevent an unfortunate side effect experienced by as many as 1 in 200 gallbladder surgery patients in the US annually.
The solution enables doctors to easily identify the bile ducts using light, a far better solution than the methods that have been used until now to identify the location of the bile ducts, indicating where doctors should avoid cutting. Using light, according to Dr. Muhammad Adileh, who led the BioDesign team on the project, is much safer and effective than current identification methods that largely rely on a doctor’s expertise.
Some 800,000 people in the US alone undergo gallbladder surgery each year, many of them for removal of this important but expendable organ. A major part of the digestive system, the gallbladder stores a greenish-brown fluid called bile, which is released by the liver and aids in the digestion process. Bile travels through the body through a network of tubes called bile ducts.
One of the most common digestive problems is the formation of gallstones, which can damage the gallbladder, with attendant pain and digestive disorders. Often, there is no alternative to removal of the gallbladder, which is done using a procedure called laparoscopic cholecystectomy, a minimally invasive procedure that is one of the most common surgical procedures worldwide. The procedure entails the insertion of a small camera (laparoscope) into the body, with pictures of the surgery area transmitted to a video screen. Doctors watch the screen as they operate, with the images guiding their actions during the procedure.
But seeing the action isn’t enough; doctors must be expert enough to identify where the bile ducts are in order to avoid cutting them when removing the gallbladder. Unfortunately, medical industry experts say, not all doctors who perform the surgery have the expertise needed to clearly identify the bile ducts – in which case doctors may inject contrast agents and fluorescent dyes into the surgical area in order to isolate the ducts. However, the BioDesign team says, this “significantly increases the duration and complexity of the laparoscopic procedure. For this reason, these technologies are seldom used.”
But the new BioDesign system – developed at the Hebrew University program along with researchers at Hadassah Medical Center – can enable doctors to easily and painlessly identify the bile ducts. The team’s research identified a unique light spectrum associated with bile acid absorption.
“We found that red light in the visible range is predominantly absorbed by bile acids in the biliary tree,” said Nahmias.
In animal experiments, the team was able to identify bile ducts just by switching the color and direction of light – and further research, the team believes, will show the same results in humans.
Researchers have long been concerned with the problems associated with gallbladder surgery, but have been reluctant to tamper with the methods doctors use. Gallbladder surgery is actually a minimally invasive procedure, requiring just a few incisions in the abdomen and the use of very thin tools to target the organ. Most of the alternative solutions that have been developed have significantly complicated the procedure, according to Dr. Muhammad Adileh, who led the BioDesign team.
“We had to find a solution that wouldn’t complicate things by changing the procedure or increasing operation time,” said Adileh.
The solution is in the targeting of light on the affected area, which clearly indicates where doctors should cut and where to avoid cutting. Eventually, said Adileh, the team hopes to develop a dedicated laparoscopic tool with the light inspection function built into it “that would allow surgeons to avoid bile duct injuries and their devastating consequences.”
Sponsored by Boston Scientific and the Terumo Medical Corporation, the BioDesign program takes outstanding medical fellows, bioengineering and business graduate students and tutors them in the science and practice of bringing a medical innovation to the market. The innovations produced by the Biodesign program participants are commercialized by Yissum, the technology transfer company of the Hebrew University of Jerusalem, and Hadasit, the technology transfer company of the Hadassah Medical Center. According to the BioDesign business development team, led by MBA students Rotem Yarkoni and Asher Saban, insurance claims amount to $1 billion annually in the United States alone, suggesting a significant market potential for the new invention.
“This is a significant discovery,” said Prof. Yaakov Nahmias, director of the Hebrew University’s Alexander Grass Center for Bioengineering which also partnered with BioDesign to develop the solution. “It allows surgeons to carry out the standard laparoscopic procedure and identify bile ducts with a single flip of a button.”