UNLABELLED: Biliary stents, placed either surgically, endoscopically or radiologically are a frequent palliative and/or curative option for treatment of obstructive jaundice. Stones or sludge formation above or inside the stent are of major concern in that they cause dysfunction of the stent that needs prompt replacement. To evaluate the efficacy of ursodeoxycholic acid (UDCA) for long-term management of surgically placed biliary stents after iatrogenic injury, a prospective, controlled, randomized trial was conducted. METHOD:Patients with biliary tract reconstruction caused by iatrogenic injury that required a transanastomotic stent were randomized into a control group (N: 29) and into a UDCA (15 mg/kg day)-treated group (N: 30). Patients were followed on an external basis and a cholangiogram was obtained to verify stent patency. Liver function tests were also analyzed. RESULTS: The two groups were compared and no differences were observed. UDCA treated patients had significant elevation of transaminases and alkaline phosphatase. Two patients in the control group and four in the treated group developed lithiasis and/or sludge. CONCLUSION: No advantages were shown with administration of UDCA to maintain the biliary stents patent and to prevent neoformation of lithiasis and/or sludge. We conclude that no benefit is obtained with administration of UDCA to patients with biliary reconstruction and a transanastomotic stent.
RCT Entities:
UNLABELLED: Biliary stents, placed either surgically, endoscopically or radiologically are a frequent palliative and/or curative option for treatment of obstructive jaundice. Stones or sludge formation above or inside the stent are of major concern in that they cause dysfunction of the stent that needs prompt replacement. To evaluate the efficacy of ursodeoxycholic acid (UDCA) for long-term management of surgically placed biliary stents after iatrogenic injury, a prospective, controlled, randomized trial was conducted. METHOD:Patients with biliary tract reconstruction caused by iatrogenic injury that required a transanastomotic stent were randomized into a control group (N: 29) and into a UDCA (15 mg/kg day)-treated group (N: 30). Patients were followed on an external basis and a cholangiogram was obtained to verify stent patency. Liver function tests were also analyzed. RESULTS: The two groups were compared and no differences were observed. UDCA treated patients had significant elevation of transaminases and alkaline phosphatase. Two patients in the control group and four in the treated group developed lithiasis and/or sludge. CONCLUSION: No advantages were shown with administration of UDCA to maintain the biliary stents patent and to prevent neoformation of lithiasis and/or sludge. We conclude that no benefit is obtained with administration of UDCA to patients with biliary reconstruction and a transanastomotic stent.
Authors: Johanna M Laukkarinen; Juhani A Sand; Pierce Chow; Hanne Juuti; Minna Kellomäki; Päivi Kärkkäinen; Jorma Isola; Sidney Yu; Satchithanantham Somanesan; Irene Kee; In Chin Song; Teck Hin Ng; Isto H Nordback Journal: J Gastrointest Surg Date: 2007-06 Impact factor: 3.452