| Background: Endoscopic retrograde cholangiopancreatography(ERCP)has been considered a minimally invasive and safe method for the management of common bile duct stones(CBDS).Large stones require mechanical lithotripsy(ML)for ductal clearance.After extraction of the stones with baskets or balloons from the bile duct,a balloon occlusion cholangiogram(OC)is routinely performed to confirm that the common bile duct(CBD)is clear.However,there are still residual fragments in the common bile duct after endoscopic retrograde cholangiopancreatography when a balloon occlusion cholangiogram was performed to confirm the bile duct was clear.These residual fragments may lead to stone recurrence.Therefore,it has been suggested that the use of normal saline to irrigate the bile duct after stone removal can increase the cleaning of the bile duct.Objective:The purpose of this trial will be to evaluate the efficacy and safety of saline solution irrigation for decreasing residual CBD stones using the SpyGlass Direct Visualization System(SpyGlass DS)and measure whether 100 ml saline irrigation is sufficient to remove retained stones from the bile duct after lithotripsy.Methods: This was a prospective self-controlled study.Patients with CBD stones who need ERCP and ML were recruited in the trial.SpyGlass DS was performed to evaluate the cleanliness of the CBD after OC confirmed no residual stones.The researchers used 50 ml of saline to irrigate the residual stones and floccule missed by OC.Then,if there still were some residual stones detected with Spyglass DS after irrigation,another 50 ml of saline was used to irrigate again,and the cleanliness of CBD was investigated with Spyglass DS.(clinical trial registration number: NCT03701009).Results: Forty-seven patients were enrolled from October 2018 to January 2020,the mean age was 61±16.5 years.The stone clearance rate for non-irrigation,washing with 50 ml and washing with 100 ml were 15%,60% and 94%,respectively.Biliary cleanliness score was 2.4±1.1 in non-irrigation group,3.5±0.7 in washing with 50 ml group and 4.6±0.6 in washing with 100 ml group(P<0.001).Multivariate analysis showed that CBD diameter>15 mm(odds ratio [OR] 4.93,95% CI 1.13-21.57;P=0.03)was an independent risk factor for massive residual CBD stones(score=1)after ERCP.Periampullary diverticulum(PAD)(OR 11.26,95% CI 1.92-66.14;P=0.002)and CBD diameter>15 mm(OR 0.08,95%CI 0.01-0.49;P=0.007)were independent risk factors for incomplete cleaning of the bile duct(score=5).The mixed model analysis showed that the amount of normal saline flushing(P<0.001)were important factors affecting the biliary cleanliness score.Pigment-based stones were the main types of stones in patients with PAD(P=0.004),and the main reason for residual stones after 100 ml saline irrigation.Conclusions: The removal rate of bile duct stones after lithotripsy can be significantly improved by flushing bile duct with 100 ml salt water.The diameter of periampullary diverticulum and CBD>15 mm is an independent risk factor for stone removal.The pigment-based stone is a reason of residual in patients with PAD. |
