1. Should I cancel or reschedule any procedures that involve a duodenoscope?
The American Gastroenterological Association recommends that patients discuss the benefits and risks with their doctor before cancelling or delaying any planned procedure. Delaying the procedure and alternatives like surgery or radiologic intervention may be riskier than a timely endoscopic retrograde cholangiopancreatography (ERCP).
2. I have heard there was an update from the FDA regarding risk of infections with duodenoscopes used for ERCP. What is the level of risk for infection and what is being done to prevent it?
The risk of getting an identified “superbug infection” with a duodenoscope is very low, currently estimated at 1 per 20,000 ERCPs performed. The complex design of duodenoscopes can sometimes result in bacteria remaining in a small portion of the duodenoscope (the “elevator channel”) even after careful cleaning according to approved instructions. The FDA continues to work with duodenoscope manufacturers to provide strict guidelines for cleaning and disinfection of these tools.
In August 2019, FDA approved new duodenoscopes with parts that are changed before each procedure. The agency recommends health care facilities start using devices with disposable parts or that are entirely disposable. However, the switch to these new duodenoscopes will be slow and orderly to make sure that there are enough duodenoscopes to perform ERCPs so that patients who need this often life-saving procedure can have still have access to the procedures.
3. I have an esophagogastroduodenoscopy (EGD) procedure coming up. Does this procedure use the same duodenoscope tool and are the risks the same?
The EGD procedure does not use the same duodenoscope that is used for ERCP. EGD uses a different endoscope than ERCP and has not been shown to have the same risk of infection because there is no “elevator channel.”
What is a duodenoscope?
A duodenoscope is a long, thin, flexible and lighted tube that is advanced by the physician, passed through the mouth, throat and stomach, and into the small intestine (duodenum). Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures. The duodenoscope has a part at the end called an “elevator channel” which allows the physician to manipulate devices. In the U.S., duodenoscopes are used in more than 650,000 ERCP procedures each year.
What is an endoscopic retrograde cholangiopancreatography (ERCP)?
Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that uses endoscopy, x-ray and dye to view the biliary tract and pancreatic ducts. Endoscopic refers to a tool called an endoscope; retrograde refers to the direction (backward, up into the ducts) the endoscope injects a liquid for x-rays; cholangio refers to the bile duct system; pancreato refers to the pancreas and graphy refers to taking pictures (x-rays). The endoscope used in ERCP is a duodenoscope.
What is ERCP used for?
ERCP can help localize and treat abnormal issues in the bile duct system and pancreas, and possibly help you avoid surgery. During the procedure, tools can be passed through the duodenoscope to relieve a blockage or narrowing in the biliary/pancreatic duct caused by stones, tumors or scarring. It can be used to remove stones and stretch or stent strictures open. This can also help relieve jaundice caused by blocked bile ducts. ERCP can treat some causes of pancreatitis or inflammation (swelling) and help prevent future attacks.
Are there any risks associated with the ERCP procedure?
You should always speak to your doctor about any concerns you have. Depending on your case, ERCP can have a total 5% to 10% risk of complications and is a safer alternative to surgery or radiologic procedures. In rare cases, severe complications may call for hospitalization. More detailed information about ERCP is available in the AGA GI Patient Center.