| Background and Objective:Distal malignant biliary obstruction includes Cholangiocarcinoma,pancreatic carcinoma,and periampullary carcinoma,Meanwhile,the placement of a stent in Endoscopic Retrograde Cholangiopancreatography(ERCP)is preferential in the palliative treatment of distal malignant biliary obstruction.With the development of adjuvant therapy with chemical and targeted drugs,the survival period and quality of life of patients with malignant biliary obstruction after chemotherapy have been improved,and the related complications after stent placement have attracted more attention in recent years.Biliary stents include plastic stents(PS)and self-expandable metallic stents(SEMS).Complications after stent placement include cholecystitis,pancreatitis,current biliary obstruction(RBO),hemorrhage,and non-occlusion cholangitis.Stent occlusion is a common complication of biliary stent placement in the treatment of distal malignant biliary obstruction.However,the patency of stent reintervention is greatly reduced due to the formation of purulent secretion and biofilms in the biliary tract.Chymotrysin is a kind of proteolytic enzyme,which can decompose the clots of fibrin in the inflammation site,promote the dissolution and decomposition of blood clots,purulent secretions and necrotic tissues,so as to purify the wound and pro mote wound healing.The objective of this pilot study was to evaluate the efficacy and safety of chymotrypsin lavage of the biliary tract after reintervention in distal malignant biliary obstruction.Methods:Twenty patients who developed stent occlusion after stent placement due to malignant biliary obstruction were enrolled in this multicenter prospective randomized controlled trial.In the experimental group,the biliary tract was irrigated with chymotrypsin by ENBD after replacement of PS,while in the control group,the biliary tract was irrigated with normal saline after replacement of PS.The main results were to record the degree of bilirubin decline and the patency of the stent.Secondary outcomes were technical succession,clinical succesions,and adverse events.Results:The median total patency time of the second stent [interquartile distance(IQR)]was 109 days(range 28-124 days).The median patency time of the experimental group was 96.5 days(35-124 days)and that of the control group was 61 days(range 28-112days).The patency time of the experimental group showed an extended trend,but was not significant(P = 0.062).The non-RBO rates of the experimental and control groups were 100% and 90% at 1 month and 50% and 30% at 3 months,respectively.alanine aminotransferase(ALT),aspartate transaminase(AST),total bilirubin(TBIL)and direct bilirubin were observed in the experimental group before and after the operation bilirubin,DB)were significantly reduced,The DB,TBIL and ALT of the experimental group at 3 days after surgery and the DB and TBIL of the outpatient review were significantly lower than those of the control group,and the difference was statistically significant(P < 0.05).The technical succession rate of both groups was 100%,and the clinical succession rate of the experimental group and the control group was 100% and90%,respectively.Stent occlusion occurred again in 4 patients(50%)in the experimental group,7 patients(70%)in the control group,and 1 patient(12.5%)in the experimental group developed mild pancreatitis after surgery.In the control group,3patients developed cholangitis after operation.No stent or chymotrypsin related serious adverse events were observed in all patients during follow-up.Conclusions:The application of chymotrypsin in the treatment of stent occlusion with malignant distal biliary obstruction can improve the related laboratory indicators of liver function more quickly,with a higher clinical succession,increased stent patency,reduced the risk of cholangitis,and no serious adverse reactions related to stents and chymotrypsin,demonstrating the effectiveness and safety of chymotrypsin in the application of biliary tract. |
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