Early endoscopic intervention versus early conservative management in patients with acute gallstone pancreatitis and biliopancreatic obstruction: a randomized clinical trial. Early ERCP and papillotomy compared with conservative treatment for acute biliary pancreatitis. The German Study Group on Acute Biliary Pancreatitis. Controlled trial of urgent endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy versus conservative treatment for acute pancreatitis due to gallstones. Duodenoscopy in treatment of acute gallstone pancreatitis. Post-ERCP pancreatitis: reduction by routine antibiotics.
To test the hypothesis that early endoscopic intervention, performed on patients with acute gallstone pancreatitis and biliopancreatic obstruction, reduces systemic and local inflammation.
                The role of early endoscopic intervention, in the treatment of acute gallstone pancreatitis, remains controversial. Previous randomized trials have not focused on the subgroup of patients with clinical evidence of biliopancreatic obstruction.
                This single-center randomized clinical trial was performed between May 2000 and September 2005. Of 238 patients, admitted within 48 hours after the onset of acute gallstone pancreatitis, 103 with a distal bile duct measuring > or =8 mm combined with a total serum bilirubin > or =1.20 mg/dL, were randomized to receive either endoscopic retrograde cholangiopancreatography followed by endoscopic papillotomy for bile duct stones (EEI, n = 51) or early conservative management (ECM, n = 52). Patients with clinical evidence of coexisting acute cholangitis were excluded. Outcome measures included changes in organ failure score and computed tomography (CT) severity index during the first week after admission, incidence of local complications, and overall morbidity and mortality.
                The incidence of bile duct stones at EEI was 72% and 40% of patients in the ECM group had persisting bile duct stones at elective biliary surgery. No significant differences were found between the EEI and ECM groups regarding changes in mean organ failure score (P = 0.87), mean CT severity index (P = 0.88), incidence of local complications (6% vs. 6%, P = 0.99), overall morbidity (21% vs. 18%, P = 0.80), and mortality (6% vs. 2%, P = 1).
                The present study failed to provide evidence that early endoscopic intervention reduces systemic and local inflammation in patients with acute gallstone pancreatitis and biliopancreatic obstruction. If acute cholangitis can be safely excluded, early endoscopic intervention is not mandatory and should not be considered a standard indication. The role of early endoscopic retrograde cholangiopancreatography (ERCP) and papillotomy in the treatment of patients who have acute biliary pancreatitis without obstructive jaundice is uncertain.
                We conducted a prospective, multicenter study in which 126 patients were randomly assigned to early ERCP (within 72 hours after the onset of symptoms) and endoscopic papillotomy for the removal of stones in the common bile duct, when appropriate, and 112 patients were assigned to conservative treatment. In the conservative-treatment group, ERCP was performed within three weeks if signs of biliary obstruction or sepsis developed. Overall mortality, mortality due to pancreatitis, and complications were compared in the two groups.
                Early ERCP was successful in 121 of the 126 patients in the invasive-treatment group. Endoscopic papillotomy was performed to remove bile-duct stones in 58 patients; stones were successfully extracted in 57. ERCP was performed in 22 of the 112 patients in the conservative-treatment group; papillotomy for stone removal was successful in 13 patients. Fourteen patients in the invasive-treatment group and 7 in the conservative-treatment group died within three months (P=0.10); 10 patients in the invasive-treatment group and 4 in the conservative-treatment group died from acute biliary pancreatis (P=0.16). The overall rate of complications was similar in the two groups, but patients in the invasive-treatment group had more severe complications. Respiratory failure was more frequent in the invasive-treatment group, and jaundice was more frequent in the conservative-treatment group.
                In patients with acute biliary pancreatis but without obstructive jaundice, early ERCP and sphincterotomy were not beneficial. 121 patients with acute pancreatitis thought to be due to gallstones were randomised to treatment with urgent endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (ES) or with conventional treatment. They were stratified by predicted severity of the attack, according to the modified Glasgow system. ERCP was done within 72 h, and if common bileduct stones were identified, patients underwent ES immediately to extract the stones. There were fewer complications in the 59 patients who underwent ERCP +/- ES than among the 62 treated conventionally, the difference being confined to those whose attacks were predicted to be severe (6/25 ERCP +/- ES [1 death] compared with 17/28 conventional treatment [5 deaths]). Hospital stay was also shorter for patients with severe attacks who underwent ERCP +/- ES than for those who received conservative treatment (median 9.5 versus 17.0 days). To probe the potential use of duodenoscopy in the diagnosis and treatment of acute gallstone pancreatitis (GP).
                Fourty-five patients with acute GP were randomly divided into endoscopic retrograde cholangiopancreatography (ERCP) group (n=20) and non-ERCP group (n=25). Each group was subdivided into mild and severe groups according to APACHE II scores. They were given supportive treatment combined with traditional Chinese medicine. The patients in the ERCP group received ERCP within 24 hours after admission. If there were stones in the common bile duct with stenosis of the inferior extremity or ampulla, endoscopic sphincterotomy (ES) was performed to extract the stones by basket. If no calculi were identified or multiple stones were large, endoscopic naso-biliary drainage (ENBD) was carried out.
                The incidence of complication, length of hospitalization and cost were markedly lower in patients with severe acute GP in the ERCP group than those in the non-ERCP group (P<0.05), in contrast to the 2 mild subgroups of the ERCP and non-ERCP groups (P>0.05).
                It is feasible, effective and safe to apply duodenoscopy in the treatment of severe acute GP. Cholangitis and pancreatitis are severe complications of endoscopic retrograde cholangiopancreatography (ERCP). Antibiotics have been considered important in preventing cholangitis, especially in those with jaundice. Some have suggested that bacteria may play a role in the induction of post-ERCP pancreatitis. It is not clear, however, whether the incidence of post-ERCP pancreatitis could be reduced by antibiotic prophylaxis, as is the case with septic complications. In this prospective study, a total of 321 consecutive patients were randomized to the following two groups: (1) a prophylaxis group (n = 161) that was given 2 g of cephtazidime intravenously 30 minutes before ERCP, and (2) a control group (n = 160) that received no antibiotics. All patients admitted to the hospital for ERCP who had not taken any antibiotics during the preceding week were included. Patients who were allergic to cephalosporins, patients with immune deficiency or any other condition requiring antibiotic prophylaxis, patients with clinical jaundice, and pregnant patients were excluded. In the final analysis six patients were excluded because of a diagnosis of bile duct obstruction but with unsuccessful biliary drainage that required immediate antibiotic treatment. The diagnosis of cholangitis was based on a rising fever, an increase in the C-reactive protein (CRP) level, and increases in leukocyte count and liver function values, which were associated with bacteremia in some. The diagnosis of acute pancreatitis was based on clinical findings, and increases in the serum amylase level (>900 IU/L), CRP level, and leukocyte count with no increase in liver chemical values. The control group had significantly more patients with post-ERCP pancreatitis (15 of 160 in the prophylaxis group vs. 4 of 155 in the control group; P = 0.009) and cholangitis (7 of 160 vs. 0 of 155; P = 0.009) compared to the prophylaxis group. Nine patients in the prophylaxis group (6%) and 15 patients in the control group (9%) had remarkably increased serum amylase levels (>900 IU/L) after ERCP, but clinical signs of acute pancreatitis with leukocytosis, CRP reaction, and pain developed in four of nine patients in the prophylaxis group compared to 15 of 15 patients with hyperamylasemia in the control group (P = 0.003). In a multivariate analysis, the lack of antibiotic prophylaxis (odds ratio 6.63, P = 0.03) and sphincterotomy (odds ratio 5.60, P = 0.05) were independent risk factors for the development of post-ERCP pancreatitis. We conclude that antibiotic prophylaxis effectively decreases the risk of pancreatitis, in addition to cholangitis after ERCP, and can thus be routinely recommended prior to ERCP. These results suggest that bacteria could play a role in the pathogenesis of post-ERCP pancreatitis
In patients with acute gallstone pancreatitis, there is no evidence that early routine ERCP significantly affects mortality, and local or systemic complications of pancreatitis, regardless of predicted severity. Our results, however, provide support for current recommendations that early ERCP should be considered in patients with co-existing cholangitis or biliary obstruction.