A new research registry has been awarded one of the largest SIR Foundation grants ever to investigate the use and role of scopes in interventional radiology—an investigation that may open up an entirely new path of IR practice.
The Percutaneous Cholangiopancreatoscopy (PCPS) registry, sponsored by SIR Foundation, will catalog the procedure data of several large academic centers. The PCPS registry is an observational, multicenter registry focused on the treatment of gallbladder and biliary tree lesions with the goal of removing indwelling drainage catheters quickly. Researchers will study tube-free survival rates as well as technical, procedural and clinical success, and complication rates.
“Scopes are generally not in the armamentarium of many interventional radiologists,” said lead researcher, Harjit Singh, MD, FSIR. “But due to recent advances in technology, there may be a role for scopes to become part of the standard IR toolkit and expand what we’re able to do, especially in the treatment of biliary and gallbladder diseases.”
According to researchers, cholangioscopes allow physicians to do procedures that aren’t possible with the standard IR tools like X-ray, needles and wires. Dr. Singh says that the gallbladder is a good example of the important role of scopes, because IRs are frequently called on to insert drains into the gallbladder for decompression. The gold standard of treatment is gallbladder removal, but some patients cannot undergo removal and so have drains inserted for life that are changed regularly. Using scopes, IRs can now remove these drains and substantially improve quality of life.
“Biliary endoscopy is a significant leap forward in terms of not only the effectiveness of interventions we provide but also the diagnostic accuracy of the work we’re doing, specifically related to bile ducts in the postsurgical setting,” said Premal Trivedi, MD, who frequently does scope work and aims to join the registry.
Emerging technology
According to researchers, the rise of disposable scopes has been crucial in opening opportunities for IRs to become more skilled and involved in endoscopic procedures.
“Endoscopy isn’t new,” said Dr. Trivedi. “It’s well established in other parts of medicine, and our GI colleagues have used scopes to diagnose and treat problems for decades. Biliary endoscopy has existed within IR for decades too—it just was a bit more niche, a bit more reserved to specific institutions, and that was largely related to the availability of the endoscope itself.”
Dr. Trivedi, who completed his fellowship with Dr. Singh at Johns Hopkins, was trained on reusable scopes from the very beginning. When he joined the University of Colorado, he turned to disposable scopes.
“When I moved out to the University of Colorado, I ran into a familiar hurdle which is that the GI doctors use their scopes all the time, so there isn’t much downtime,” he said. “And that’s where the disposable scopes were transformative.”
According to Dr. Trivedi, reusable endoscopes posed a challenge due to the fact that acquiring and maintaining them can be costly—which meant only certain centers were able to afford them.
Disposable scopes, Dr. Trivedi said, have opened the door to new possibilities in his own practice. “We’ve significantly increased the number of patients we can treat and accurately diagnose with the correct biliary problem and get them to the right treatment and for a lot of patients that means a transformative change in their life, going from being catheter dependent to living drain-free and cured of their problems.”
Disposable scopes make the technology more accessible, Dr. Trivedi said.
“With disposable endoscopes, we’ve taken care of that technology component,” he said. “You don’t have to build relationships in other departments in quite the same way and be dependent on whether they are not using the scope. That was a real key. Now you can have a vendor come and provide a cholangioscope per case and you throw it away, and it’s relatively affordable when you consider reimbursement.”
Due to the rise of this new accessible technology, Dr. Trivedi believes that it’s never been a better time to get involved.
“We are in a new era of biliary intervention, and this is transforming diagnosis and treatment,” he said. “The time to start getting into this space is right now—we have good data and society support to be able to shorten the learning curve significantly at this point. And what is clear is that if it’s not in your toolkit, then there’s an inherent limitation in what you can do in terms of accuracy and effectiveness of both diagnosis and treatment.”
One way to get involved is through enrolling in the PCPS registry to share and collect data.
Collecting the data
According to researchers, those who do scope work typically only do a handful of interventions each year—so they need a lot more data than each site can individually produce in order to answer questions and fully investigate the effectiveness of PCPS. The data registry will not only solve this problem, but also encourage education and learning, researchers believe.
But one of the roadblocks with registries, Dr. Singh said, is the onus it puts on staff to input data. “People are eager to join, but so many cannot dedicate the time to inputting data,” he said.
Following a research consensus panel held in 2022 to identify priorities regarding percutaneous image- and endoscopy-guided procedures for biliary and gallbladder diseases, the PCPS registry was awarded a grant to support Dr. Singh’s efforts.
The grant from SIR Foundation will provide financial support for a dedicated staff member at each location and enable them to spend the time required to input registry data. “Many sites could not have participated without the support offered by the grant—this grant saved the project,” Dr. Singh said.
Obtaining the grant
Dr. Singh received the SIR Foundation grant through the letter of intent (LOI) process, wherein physicians interested in conducting a research trial, registry or other type of study can submit an LOI which describes the project’s significance, proposed data outcomes and intended role of SIR Foundation. Researchers can follow one of three pathways when submitting an LOI, depending on whether they would like support for a registry, trial or research consensus panel.
Conclusion
The registry is currently enrolling, Dr. Singh says. Researchers hope to enroll at least 540 participants within the registry over the next five years and are seeking non-pregnant adult patients with clinical indications for the PCPS procedure.
The opportunities created by the registry may be transformative, Dr. Singh says.
“By having data to support the efficacy of scopes in existing procedures, it will demonstrate the utility of the scope for our IR patients.”
