medwireNews: The endoscopic ultrasound-guided rendezvous technique (EUS-RV) and precut sphincterotomy have similar success rates for cannulation of difficult bile ducts in benign biliary disease, with acceptable complication rates for both, a study suggests.
“Although more studies and newer methods are gaining interest for biliary drainage in malignant biliary obstruction, data on biliary access for benign disease is scanty, and our study adds to that,” write Jayanta Samanta (Postgraduate Institute of Medical Education and Research, Chandigarh, India) and colleagues in the Annals of Internal Medicine.
Deep cannulation of the common bile duct during endoscopic retrograde cholangiopancreatography (ERCP) has a failure rate of 10-20%, the authors say. A direct comparison of precut sphincterotomy and the more modern EUS-RV as salvage strategies “would be useful to guide clinical care,” they add.
The investigators enrolled 100 patients over the age of 18 years with benign biliary disease and difficult bile duct cannulation requiring a salvage strategy, and randomly assigned them to receive either EUS-RV or precut sphincterotomy (n=50 in each group). Difficult bile duct cannulation was defined as either more than five contacts with the papilla, more than 5 minutes spent attempting cannulation after papilla visualization, or more than one unintended pancreatic duct cannulation or opacification.
Following the procedure, the researchers monitored the progress of the patients until hospital discharge and for 8 hours afterwards as outpatients, as well as calling at 24 hours to check for possible complications.
Overall, the participants had a mean age of 51.7 years and 72% were women. The most common indications for ERCP were choledocholithiasis (79%) and biliary stricture (12%), and 19% of the patients had mild, moderate, or severe cholangitis.
Samanta et al found that the EUS-RV and precut sphincterotomy treatment groups had a similar rate of successful deep biliary cannulation on cholangiogram (92 vs 90%). Moreover, all patients whose initial procedure failed had a successful salvage procedure by the alternative technique, leading the authors to observe that “the 2 salvage techniques are complementary to each other and can help achieve successful cannulation in all cases when used in any sequence.”
The EUS-RV and precut sphincterotomy groups also had a similar median procedure time (10.10 vs 9.75 minutes) and there was no difference in the overall complication rate for the two groups (12 vs 10%). There were no bleeding or perforation events in either group, but 4% of patients receiving EUS-RV had an infection after the procedure.
Samanta and colleagues found that 10% of patients in each group developed post-ERCP pancreatitis (PEP), which was classed as new or worsened abdominal pain combined with three or more times the normal value of amylase or lipase at more than 24 hours after ERCP and requirement of admission or prolongation of a planned admission. One person had a moderately severe form of the condition, and the rest of the cases were mild.
In an analysis of a subgroup of patients who did not have inadvertent pancreatic duct cannulation (n=72), the EUS-RV group had no cases of PEP compared with 5.6% in the precut sphincterotomy group, although the authors comment that the study “was not powered to evaluate this aspect.”
The researchers cite other limitations to the study, including that it was carried out at a single center and may lack generalizability. Additionally, the participants were mostly women, which could influence the risk for PEP and other factors.
Samanta et al conclude that “EUS-RV is not superior to precut sphincterotomy as a salvage technique” but “in case of failure of one technique, crossover to the other technique can help achieve successful cannulation in all cases.”
They add: “A larger, multicenter [randomized controlled trial] would be required to evaluate the probable benefit of lower PEP in the EUS-RV approach.”
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