Comparing the Effects of EST and EPBD in Patients With Acute Biliary Pancreatitis
Comparing the Effects of EST and EPBD in Patients With Acute Biliary Pancreatitis
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.
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. They will be
 randomized into two treatment groups (sphincterotomy vs. balloon dilation).

 Inclusion Criteria:

 Patients diagnosed with acute gallstone pancreatitis and fulfill any two items from a to c,
 plus one item in d, and e:

 1. abdominal pain typical of pancreatitis;

 2. elevation of serum amylase and/or lipase up to three times above normal;

 3. imaging studies (abdominal ultrasound or abdominal computed tomography) showed
 evidence of pancreatitis

 4. common bile duct stones, acute cholangitis (Charcot's triad), total bilirubin (total
 bilirubin)> 4mg / dL, bile duct dilatation (diameter> 6mm with intact gallbladder, or>
 10mm when the gallbladder has been removed) plus total bilirubin 1.8 ~ 4mg / dL;

 5. exclude other causes of acute pancreatitis.

 Exclusion Criteria:

 -  septic shock

 -  serious coagulopathy (international normalized ratio 1.5, partial thromboplastin time
 greater than twice that of control, platelet count <50 x 1000 / Cumm)

 -  malignant tumors of the biliary and pancreatic tract

 -  severe cardiovascular or mental illness which can not cooperate with the exam and
 treatment;

 -  pregnant women

 -  patient who had ever received surgery or endoscopic treatment for biliopancreatic
 tract