Salvage EUS-RV, Precut Sphincterotomy Comparable for Difficult Bile Duct Cannulation

Arup Choudhury, MD

Credit: ResearchGate

Findings from a recent study are providing clinicians with an overview of the use of endoscopic ultrasound-guided rendezvous technique (EUS-RV) and precut sphincterotomy as salvage techniques for patients with benign biliary disease and difficult bile duct cannulation.¹

The study was published in Annals of Internal Medicine and results suggest similar technical success, procedure time, and complication rates with both EUS-RV and precut sphincterotomy. Of note, failed cases in either salvage group could be successfully cannulated when crossed over to the other group.¹

Biliary cannulation in endoscopic retrograde cholangiopancreatography (ERCP) is unsuccessful in as many as 20% of patients, and once cannulation has been deemed difficult, the risk of post-ERCP pancreatitis and technical failure increases. Although multiple salvage techniques have been proposed, data regarding their rate of success and adverse events have been variable.² Precut sphincterotomy has historically served as the standard salvage technique used for difficult bile duct cannulation, but EUS-RV has recently emerged as another promising salvage method.¹

“In the presence of availability of technical expertise for both techniques, a direct comparison of the 2 methods would be useful to guide clinical care,” Arup Choudhury, MD, an associate professor at the Postgraduate Institute of Medical Education and Research in India, and colleagues wrote.¹ “There are limited data on the comparison between these 2 salvage techniques of precut sphincterotomy and EUS-RV for difficult bile duct cannulation… To the best of our knowledge, this is the first RCT that has compared the 2 salvage methods of EUS-RV and precut sphincterotomy for difficult bile duct cannulation.”

To compare EUS-RV and precut sphincterotomy as salvage techniques for difficult bile duct cannulation in benign biliary obstruction, investigators conducted a participant-masked, parallel-group, superiority randomized controlled trial at the Postgraduate Institute of Medical Education and Research in Chandigarh, India, from July 2020 to May 2021. For inclusion, patients were required to be ≥ 18 years of age with a benign cause of extrahepatic biliary obstruction with native papilla. Additionally, they were required to have difficult bile duct cannulation at the index ERCP attempt, defined as either > 5 contacts with the papilla, > 5 minutes spent at cannulation attempt after papilla visualization, or > 1 unintended pancreatic duct cannulation or opacification.¹

After excluding patients with previous sphincterotomy of the papilla, malignant biliary obstruction, and those who did not provide informed consent, 100 participants were enrolled in the study and randomly assigned in a 1:1 ratio to either EUS-RV or precut sphincterotomy. Patients were blinded to the technique used for salvage, and those with failed precut sphincterotomy were crossed over to EUS-RV and vice versa.¹

The primary outcome measure was technical success, defined as successful deep biliary cannulation confirmed on cholangiogram using either of the 2 techniques. Other outcome measures included procedure time, radiation dose, and adverse events.¹

Among the cohort (n = 100), the majority of participants were female (72%) and the mean age was 51.7 (Standard deviation, 14.2) years. All were randomly assigned to EUS-RV (n = 50) or precut sphincterotomy (n = 50), with the most common indications for ERCP being choledocholithiasis (79%) followed by biliary stricture (12%). Investigators noted cholangitis in 19% of cases.¹

Overall, deep biliary cannulation was achieved in 91 patients using either of the 2 initial salvage techniques. Investigators pointed out technical success was similar between the EUS-RV (92%; 95% CI, 80.7% to 97.7%) and precut (90%; 95% CI, 78.2% to 96.6%) groups (P = 1.00), as were the median procedure time (10.1 vs 9.75 minutes), and overall complication rate (12% vs 10%; relative risk, 1.20; 95% CI, 0.39 to 3.68).¹

Of the 4 failed EUS-RV cases, 3 had failed guidewire negotiation, whereas 1 did not have a safe vessel-free window. Of the 5 failed precut cases, bile duct could not be accessed in 4 despite optimum dissection, whereas in 1 case, an adequate cut could not be attempted due to an indistinct margin secondary to a large periampullary diverticulum.¹

Investigators noted 10% (95% CI, 3% to 21.8%) of patients in both groups developed post–ERCP pancreatitis. Of these cases, 1 in the EUS-RV had moderately severe pancreatitis, whereas the rest had mild pancreatitis.¹

On crossover, all failed cases in the EUS-RV group could be cannulated successfully by precut sphincterotomy and vice versa. Thus, investigators noted all of the cases had eventual successful deep biliary cannulation.¹

They acknowledged multiple limitations to these findings, including a potential lack of generalizability due to the single-center study design; the lack of a cost-efficacy analysis for EUS-RV, which includes additional costs for a needle and a separate scope; the disproportionate amount of female participants; and the need for larger studies to validate the negligible difference in technical success between the 2 groups.¹

“EUS-RV is not superior to precut sphincterotomy as a salvage technique for difficult bile duct cannulation in benign biliary diseases, and has a similar adverse event profile to precut sphincterotomy,” investigators concluded.¹ “Moreover, in case of failure of one technique, crossover to the other technique can help achieve successful cannulation in all cases.”

References

1. ^{Choudhury A, Samanta J, Muktesh G, et al. Endoscopic Ultrasound-Guided Rendezvous Technique Versus Precut Sphincterotomy as Salvage Technique in Patients With Benign Biliary Disease and Difficult Biliary Cannulation: A Randomized Controlled Trial. Ann Intern Med. doi:10.7326/M24-0092}
2. ^{Berry R, Han JY, Tabibian JH. Difficult biliary cannulation: Historical perspective, practical updates, and guide for the endoscopist. World J Gastrointest Endosc. doi:10.4253/wjge.v11.i1.5}