A prospective multicentre German trial enrolled 238 patients with ABP who had no evidence of obstructive jaundice, and assigned them to either ERCP within 72 h of admission or conventional therapy. Of the 126 patients in the interventional group, 121 (96%) successfully underwent ERCP, and 58 proved to have choledocholithiasis. Twenty of the 112 patients in the control group subsequently required ERCP, and 13 of these underwent removal of CBD stones. There were no significant differences in the morbidity or mortality rates between the two groups, but patients who received early ERCP experienced a higher incidence of respiratory failure and more severe complications. Moreover, there was a trend toward increased mortality in the ERCP group, which was contrary to the findings of the other RCTs. Stratification of the patients according to the severity of disease did not affect the findings.
This study involved only patients with ABP who did not have obstructive jaundice, and, thus, it may be surmised that this subgroup of patients do not require ERCP. Many concerns about the design and results of this trial have been raised, however, and confirmatory studies are needed.
The first concern is about the small number of patients enrolled by each of the 22 centres that participated in the German trial. On average, only 10.8 patients (range six to 29) were enrolled at each centre during a period of 54 months, or 2.4 patients per centre each year. Three sites enrolled 20 or more patients, and so the remaining 19 centres studied fewer than two patients per year. In contrast, the single-centre United Kingdom and Hong Kong trials enrolled 121 and 195 patients, respectively. It is known that ERCP and ES are technically demanding procedures, and that proficiency requires ongoing experience. Therefore, the lack of benefit from early endoscopic therapy may reflect the lack of available patients or inadequate expertise.
The second concern addresses the finding that early ERCP was associated with a five-fold increase in the incidence of respiratory failure, as defined by an inability to maintain a partial pressure of arterial oxygen above 60 mmHg with an oxygen mask, and a trend towards increased mortality rates. While hypoxemia is a frequent complication of severe pancreatitis, this complication was not associated with ERCP in either the United Kingdom or Hong Kong trial. The P value for the respiratory failure finding was 0.03. It has been argued that the significance level should have been corrected for the use of multiple comparisons (Bonferroni correction), instead of using the standard 0.05 threshold value. You deserve best quality care that costs less money than you could expect: all you need at this point is to discover very low prices on prescription drugs that do not require a prescription: purchase cialis online only here for wisest customers.