Large-Caliber Dilation Without Sphincterotomy Is Efficacious and Safe for Stones >10 mm
Bret T. Petersen, MD, MASGE, reviewing Kogure H, et al. Endoscopy 2020 Apr 16.
Endoscopic biliary sphincterotomy (ES) is the standard prelude to duct stone removal; however, it carries moderate risk for both pancreatitis and bleeding and can be challenging to use in some anatomy. Balloon dilation or sphincteroplasty has been used for a number of years to remove small stones, and large-caliber balloon sphincteroplasty (LCBS) after short to moderate sphincterotomy has been shown to reduce the need for lithotripsy techniques when removing large stones.
The authors of this randomized multicenter study, which included 171 patients, compared the efficacy and safety of ES alone versus LCBS alone for removing large (>10 mm) stones from the common bile duct. Complete duct clearance was more commonly achieved in one session with LCBS than with ES (90.7% vs 78.8%; P=.04), and the use of endoscopic lithotripsy was less common with LCBS than with ES (30.2% vs 48.2%; P=.02). The rates of both the overall adverse events (9.3% with LCBS vs 9.4% with ES) and procedural pancreatitis (4.7% with LCBS vs 5.9% with ES) were comparable. The total procedural cost was numerically but not statistically lower in the LCBS group ($1442 vs $1661; P=.12).
COMMENTThe original U.S. study of balloon sphincteroplasty versus ES for the removal of small stones experienced serious adverse events, generating hesitation domestically regarding the technique. Subsequent international studies and experience with the use of ES plus LCBS to remove large stones have confirmed relative safety, efficiency, and cost-effectiveness. This study demonstrates equivalent safety and greater efficacy of LCBS alone versus ES alone for removing large stones. This should ease concerns about balloon dilation without ES in patients with coagulopathy and during long-limb or percutaneous procedures, with which ES is particularly difficult. Rectal indomethacin should undoubtedly be used in these cases.
Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
CITATION(S)
Kogure H, Kawahata S, Mukai T, et al. Multicenter randomized trial of endoscopic papillary large
balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trial. Endoscopy 2020 Apr 16. (Epub ahead of print) (https://doi.org/10.1055/a-1145-3377)
