Choledocholithiasis Which Approach and When? Lygia Stewart, MD University of California, San Francisco 2010 Naffziger Post-Graduate Course Clinical Manifestations of Choledocholithiasis Asymptomatic (no objective signs) Signs of biliary obstruction Elevated LFTs Biliary dilatation Hx of dark urine, acholic stools Pancreatitis Cholangitis Treatment Approaches ERCP / PTC Surgical Laparoscopic vs open Timing and order of approach Predictors of Choledocholithiasis 1
Predictors of Choledocholithiasis Age Bilirubin CBD Dilated on US > 55 years < 55 years Probability of CBD Stones > 1.8 mg/dl Yes 72% No 50% < 1.8 mg/dl Yes 61% No 38% > 1.8 mg/dl Yes 49% No 28% < 1.8 mg/dl Yes 38% No 19% Predictors of Choledocholithiasis Multivariate Analysis 233 patients Score > 3 = CBD stones 80% Specificity 82% Sensitivity Barkun et al, Ann Surg 1994 ; 220: 32 39 39 UC Menzes et al, Br J Surg 2000; 87: 1176-1181 1181 SF Dx CBD Stones: EUS vs ERCP Meta-Analysis 4 Randomized controlled studies 423 patients 213: EUS-guided ERCP 210: ERCP alone EUS first - avoided ERCP in 67% of patients P P < 0.001 Complications ERCP should not be used to Dx CBD stones Choledocholithiasis at time of Lap Chole Petrov et al, Br J Surg 2009; 96: 967-974974 2
Incidence & Natural Hx CBD Stones 999 Lap Chole cases over 11 years IOC 962 patients Filling defect > fine cholangiocath cystic duct Repeat cholangiography 48 hrs / 6 weeks 46 patients (4.6%) filling defect 12 (26%) normal 48 hours (? False +) 12 (26%) normal 6 weeks 22 patients (2.2% total) persistent CBD stones Treated with ERCP Spontaneous passage not determined by number/size stones or CBD diameter Lap Trans-cystic CBDE Trans-cystic CBDE Successful in 80% 98% of cases Collins et al, Ann Surg 2004; 239: 28 33 Hungness & Soper, JOGS 2006; 10: 612-619619 LapCBDE vs Pre-op ERCP Cuschieri, et al European Association of Endoscopic Surgery (E.A. E.S.) Can J Surg 2002;45: 207-9 N = 300 Lap CBDE or Post-op op ERCP? Rogers, et al Arch Surg 2010;145: 28-33 N = 122 Hospital Stay Lap CBDE 55 hours ERCP/LC 98 hours P = 0.001 Rhodes et al, Lancet 1998; 351: 159 61 Lap CBDE ERCP P Value Procedure Time (Min) 90 105 1.0 Initial Success 30/40 (75%) 30/40 (75%) 1.0 Bile leak 3/40 ERCP X1, re-op X1 1/40 ERCP X1 0.6 Hospital Stay 1 day (range 1-26) 3 5 days (range 1-11) 11) 0.0001 3
Lap Choledochotomy or P-op ERCP? Prospective randomized study 7 Metropolitan Hospitals Experienced Surgeons 78% of CBD stones treated with trans-cystic CBDE Choledochotomy > 7mm CBD, no inflammation Choledochotomy ERCP P Value Procedure Time (Min) 159 148 0.49 Re-operation 2/41 (5%) 2/45 (4%) 1.0 Late re-operation 1/41 Strict @ CBD closure Bile leak 6/41 ERCP X3, re-op X1 1/45 Stricture @ CyD 1.0 0 0.01 Biliary Pancreatitis Nathanson et al, Ann Surg 2005; 242: 188 192 Severity of Pancreatitis Ranson Criteria Admission Age >55 yrs Age >55 yrs Wbc Count > 16 K Glucose >200 mg/dl AST > 250 IU/L LDH > 350 IU/L Glasgow Criteria Wbc Count > 15 K Glucose >200 mg/dl BUN > 45 mg/dl PaO 2 < 76 mmhg 48 Hours Increase BUN > 8 mg/dl Albumin < 3.4 gm/dl Ca < 8.0 mg/dl PaO 2 < 60 mmhg Base deficit < 4 Meg/L Fluid sequestration > 6 L Ca < 8.0 mg/dl AST/ALT >96 units/l LDH >219 units/l Mortality: 0 2 = 2%, 3-4 = 15%, 5-6 = 40%, > 7 = 100% Meta-Analysis, ERCP vs Conservative Complications 5 prospective randomized studies 702 patients Cases with cholangitis excluded ERCP < 72 hours P = 0.01 A. Moretti et al, Digestive and Liver Disease 2008; 40: 379 385 385 4
Meta-Analysis, ERCP vs Conservative Complications: Severe vs Mild Pancreatitis Distribution Severe 232 (33%) Ranson > 3 Glascow > 3 APACHE II > 6-8 Mild 470 (67%) Morbidity Mild 13% Severe 41% P < 0.0001 Mortality Mild 0% Severe 13% P < 0.0001 P < 0.6 P < 0.0001 Meta-Analysis, ERCP vs Conservative Mortality Rate 5 prospective randomized studies 702 patients Cases with cholangitis excluded P = 0.9 A. Moretti et al, Digestive and Liver Disease 2008; 40: 379 385385 A. Moretti et al, Digestive and Liver Disease 2008; 40: 379 385 385 Meta-Analysis, ERCP vs Conservative Mortality Rate - Severe 4 prospective randomized studies Addressing severe acute biliary pancreatitis P < 0.2 Acute Pancreatitis Randomized Trials: Open Surgery Kelly, Surgery 1988, N=165 >3 Ranson s Criteria Early Surgery After Resolution Pancreatitis P Value Morbidity 83% 18% < 0.0001 Mortality 48% 11% 0.02 Ranson, Ann Surg 1979, N=74 >3 Ranson s Criteria Mortality 67% 0% 0.003 A. Moretti et al, Digestive and Liver Disease 2008; 40: 379 385385 5
Cholangitis - Clinical Presentation Cholangitis Charcot s triad present in 50-70% of patients RUQ pain, jaundice, fever and chills Most (>90%) have fever, RUQ pain, and jaundice (50-70%) Leukocytosis common - parallels endotoxemia Elevated bilirubin and alkaline phosphatase Should be considered in any patient with jaundice, fever and abdominal pain, especially when gallstones are present Bacterial Detachment from Biofilm and Cholangiovenous Reflux Bacteremia Cholangitis Pathophysiology Cholangiovenous reflux of bacteria (and endotoxin) from the biliary tree into the systemic circulation Requires bacteria in bile and elevated biliary pressure (> 20 cm H 2 0) Source of bacteria is bacterial-laden gallstones in the biliary tree Bactibilia 6
Cholangitis Randomized Trial: Open Surgery vs ERCP Surgery ERCP P Value Lai, NEJM 1992, N=82 Morbidity 66% 34% 0.008 Mortality 32% 10% 0.027 Endotoxemia and Cholangitis 40 patients - cholangitis from gallstones Bile and serum endotoxin measured using Limulus Lysate assay Serum and bile endotoxin decreased markedly after endoscopic drainage, especially in the first 24 hours ERCP is the treatment of choice for Cholangitis Lau JYW, et al., Br J Surg 1996 Conclusions There is no role for ERCP purely for the diagnoses of Choledocholithiasis EUS and MRCP are equivalent diagnostically and confer less risk Pre-op ERCP should be utilized in cases with inflammatory manifestations of CBD stones (Cholangitis, severe Pancreatitis), or elderly / high-risk patients Conclusions Lap CBDE and post-op ERCP are both safe and reliable in clearing CBD stones There is no evidence of a difference in efficacy, morbidity, or mortality LapCBDE has a shorter hospital stay ERCP / sphincterotomy is the recommended treatment for CBD stones post-cholecystectomy NIH Consens State Sci Statements. 2002 Jan 14-16;19(1):1 16;19(1):1-26. NIH state-of-the-science statement on ERCP for diagnosis and therapy 7
Gallstone Pancreatitis Patients with (predicted) severe biliary pancreatitis should undergo ERCP with sphincterotomy and stone extraction within 72 hours Including cases with signs of ongoing biliary obstruction and cholangitis Mild Pancreatitis should be treated with surgery once the inflammatory illness has resolved (within 2 weeks) Cholangitis ERCP / sphincterotomy is the primary treatment for cholangitis due to CBD stones These patients require immediate resuscitation with IV fluids and antibiotics For patients who do not improve promptly, ERCP / sphincterotomy / duct drainage is indicated ASAP For patients who improve, urgent (within 24 hours) ERCP / sphincterotomy is indicated PTC drainage can be used as an alternative to ERCP but open surgery should be avoided NIH Consens State Sci Statements. 2002 Jan 14-16;19(1):1-26. NIH state-of-the-science statement on ERCP for diagnosis and therapy Thank-you 8