Acute Biliary Pancreatitis Clinical Trial
Official title:
Prospective Randomized Study Comparing the Effects of Endoscopic Sphincterotomy (EST) and Endoscopic Papillary Balloon Dilation (EPBD) in Patients With Acute Biliary Pancreatitis (ABP)
This study compares the effect of endoscopic sphincterotomy and endoscopic papillary balloon dilation in the treatment of acute biliary pancreatitis.Participants with acute biliary pancreatitis will be randomized into either the endoscopic sphincterotomy or endoscopic papillary balloon dilation groups.Moreover, the investigators compare the results obtained from the traditional bile/blood culture and metagenomics.
Early endoscopic retrograde choledocho pancreatogram with endoscopic sphincterotomy is
suggested in patients with acute biliary pancreatitis to reduce complication and mortality.
Retrospective study of the investigators' hospital showed that endoscopic papillary balloon
dilation is safe in the treatment of acute biliary pancreatitis. However, there is no report
in literature concerning about the prospective study comparing the effect of endoscopic
sphincterotomy and endoscopic papillary balloon dilation in the treatment of acute biliary
pancreatitis.
Moreover, the presence of infective microorganisms in the biliary and/or pancreatic ducts
may play important role in both the onset and outcome of acute biliary pancreatitis. Blood
or bile obtained via endoscopic means is another way to know the causative
bacterium/bacteria.
However, it still need considerable period of time to get the result of the culture.
Recently, next-generation sequencing technologies have been developed, which can facilitate
the analysis of a large number of microorganisms in different environments and human body
sites. 16S(a svedberg unit) ribosomal deoxyribonucleic acid sequence analysis and
metagenomics are two effective DNA sequencing approaches, and both have been used to study
uncultivated gut microbial communities.
Aims:
1. To study the clinical effects of endoscopic sphincterotomy and endoscopic papillary
balloon dilation in acute biliary pancreatitis.
2. To compare the results obtained from the traditional bile/blood culture and
metagenomics.
Methods: Beginning from Jan 2016, patients with age ≥ 20 years and acute biliary
pancreatitis concomitant with either signs of acute cholangitis or bile duct obstruction
will be enrolled in the study. Participants will be randomized into either the endoscopic
sphincterotomy or endoscopic papillary balloon dilation groups. The treatment effects and
safety of both groups will be compared. The primary endpoint is the relative successful
rates of retrieval of common bile duct stones of both groups. The secondary endpoint is the
frequency of use of mechanical lithotripter, other drainage procedures, complication and
mortality, as well as the number of treatment sections.
Besides blood culture exam, bile will be aspirated by placing a single-use, 5-French,
standard catheter (after guide-wire cannulation) into the bile duct before the injection of
contrast agent for endoscopic retrograde cholangiopancreaticography. Approximately 10 mL of
bile will be collected and transferred in a sterile tube. Half of the bile obtained will be
transported to the microbiology laboratory in blood culture bottles and in an anaerobic
transport system. Bacteria will be cultured and identified according to the standard
protocol used in our clinical microbiology laboratory. Another half of the bile specimen
will be sending for metagenomic study. Finally, investigators will try to compare the
results obtained from the traditional bile culture /blood culture and metagenomics, and to
understand the effects of infective microorganisms in the biliary and/or pancreatic ducts on
the acute biliary pancreatitis. In addition, investigators want to find out the best means
of early and accurate diagnosis of the pathogen responsible for the infection.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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