Matthew J Burstow1, Rossita M Yunus, Md Belal Hossain, Shahjahan Khan, Breda Memon, Muhammed A Memon. 1. *Department of Surgery, Royal Brisbane and Women's Hospital †School of Agricultural, Computing and Environmental Sciences, Australian Centre for Sustainable Catchments, University of Southern Queensland, Toowoomba ∥Sunnybank Obesity Centre and SEQS, McCullough Centre, Sunnybank ¶Department of Surgery, Mayne Medical School, University of Queensland, Herston #Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia ‡Institute of Mathematical Sciences, University of Malaya, Kuala Lumpur, Malaysia §Department of Statistics, Biostatistics & Informatics, Dhaka University, Dhaka, Bangladesh **Faculty of Health and Social Science, Bolton University, Bolton, Lancashire, UK.
Abstract
CONTEXT: The utility of early endoscopic retrograde cholangiopancreatography (ERCP) ± endoscopic sphincterotomy (ES) in the treatment of gallstone pancreatitis (GSP) is still contentious. OBJECTIVES: The aim was to conduct a meta-analysis of randomized controlled trials (RCTs) investigating the treatment of GSP by early ERCP ± ES versus conservative management and analyzing the patient outcomes. DATA SOURCES: A search of Medline, Embase, Science Citation Index, Current Contents, PubMed, and the Cochrane Database of Systematic Reviews identified all RCTs comparing early ERCP to conservative management in GSP published between January 1970 and January 2014. Search terms included "Endoscopic retrograde cholangiopancreatography (ERCP)"; "Endoscopic sphincterotomy"; "Gallstones"; "Bile duct stones"; "Gallstone pancreatitis"; "Biliary pancreatitis"; "Randomize/Randomised controlled trials"; "Conservative management/treatment"; "Human"; "English." STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, AND INTERVENTIONS: Only prospective RCTs comparing early intervention (ie, between 24 and 72 h) with ERCP ± ES versus conservative management in GSP were included. STUDY APPRAISAL AND SYNTHESIS METHODS: Data extraction and critical appraisal was carried out independently by 2 authors (M.J.B. and M.A.M.) using predefined data fields. Variables analyzed included severity of pancreatitis (mild or severe), overall mortality, overall complications which included pseudocyst formation, organ failure (renal, respiratory, and cardiac), abnormal coagulation, biliary sepsis, and development of pancreatic abscess/phlegmon. The quality of RCTs was assessed using Jadad's scoring system. Random-effects model was used to calculate the outcomes of both binary and continuous data. Heterogeneity among the outcome variables of these trials was determined by the Cochran Q statistic and I2 index. The meta-analysis was prepared in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines. RESULTS: Eleven RCTs consisting of 1314 patients (conservative management=662, ERCP=652) were analyzed. There was a near significant decrease in mortality for ERCP group compared with conservatively managed patients with severe pancreatitis [odds ratio (OR) 0.45; 95% confidence interval (CI), 0.19, 1.09; P=0.08]. In patients with mild pancreatitis, mortality results were comparable for both groups (OR 0.66; 95% CI, 0.02, 28.75; P=0.83). Overall complications were significantly reduced in the ERCP group in severe pancreatic patients (OR 0.32; 95% CI, 0.17, 0.61; P=0.00). In those with mild disease, a strong trend to decreased complications in the ERCP group was seen, however, this was not significant (OR 0.67; 95% CI, 0.43, 1.03; P=0.06). CONCLUSIONS: This meta-analysis demonstrates a significant decrease in complications in patients with severe GSP managed with early ERCP/ES compared with conservative management. As far as the mortality is concerned, no significant decrease was observed in mortality even in severe GSP patients treated with early ERCP/ES.
CONTEXT: The utility of early endoscopic retrograde cholangiopancreatography (ERCP) ± endoscopic sphincterotomy (ES) in the treatment of gallstone pancreatitis (GSP) is still contentious. OBJECTIVES: The aim was to conduct a meta-analysis of randomized controlled trials (RCTs) investigating the treatment of GSP by early ERCP ± ES versus conservative management and analyzing the patient outcomes. DATA SOURCES: A search of Medline, Embase, Science Citation Index, Current Contents, PubMed, and the Cochrane Database of Systematic Reviews identified all RCTs comparing early ERCP to conservative management in GSP published between January 1970 and January 2014. Search terms included "Endoscopic retrograde cholangiopancreatography (ERCP)"; "Endoscopic sphincterotomy"; "Gallstones"; "Bile duct stones"; "Gallstone pancreatitis"; "Biliary pancreatitis"; "Randomize/Randomised controlled trials"; "Conservative management/treatment"; "Human"; "English." STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, AND INTERVENTIONS: Only prospective RCTs comparing early intervention (ie, between 24 and 72 h) with ERCP ± ES versus conservative management in GSP were included. STUDY APPRAISAL AND SYNTHESIS METHODS: Data extraction and critical appraisal was carried out independently by 2 authors (M.J.B. and M.A.M.) using predefined data fields. Variables analyzed included severity of pancreatitis (mild or severe), overall mortality, overall complications which included pseudocyst formation, organ failure (renal, respiratory, and cardiac), abnormal coagulation, biliary sepsis, and development of pancreatic abscess/phlegmon. The quality of RCTs was assessed using Jadad's scoring system. Random-effects model was used to calculate the outcomes of both binary and continuous data. Heterogeneity among the outcome variables of these trials was determined by the Cochran Q statistic and I2 index. The meta-analysis was prepared in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines. RESULTS: Eleven RCTs consisting of 1314 patients (conservative management=662, ERCP=652) were analyzed. There was a near significant decrease in mortality for ERCP group compared with conservatively managed patients with severe pancreatitis [odds ratio (OR) 0.45; 95% confidence interval (CI), 0.19, 1.09; P=0.08]. In patients with mild pancreatitis, mortality results were comparable for both groups (OR 0.66; 95% CI, 0.02, 28.75; P=0.83). Overall complications were significantly reduced in the ERCP group in severe pancreaticpatients (OR 0.32; 95% CI, 0.17, 0.61; P=0.00). In those with mild disease, a strong trend to decreased complications in the ERCP group was seen, however, this was not significant (OR 0.67; 95% CI, 0.43, 1.03; P=0.06). CONCLUSIONS: This meta-analysis demonstrates a significant decrease in complications in patients with severe GSP managed with early ERCP/ES compared with conservative management. As far as the mortality is concerned, no significant decrease was observed in mortality even in severe GSP patients treated with early ERCP/ES.