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Comparing the Effects of EST and EPBD in Patients With Acute Biliary Pancreatitis

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ClinicalTrials.gov Identifier: NCT02668081
Recruitment Status : Unknown
Verified January 2016 by Hoi-Hung Chan, Kaohsiung Veterans General Hospital..
Recruitment status was:  Recruiting
First Posted : January 29, 2016
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hoi-Hung Chan, Kaohsiung Veterans General Hospital.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Biliary Pancreatitis Procedure: Endoscopic papillary balloon dilation Procedure: Endoscopic sphincterotomy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endoscopic papillary balloon dilation
For EPBD group, after selective cannulation of the common bile duct by the catheter, cholangiography will be performed to confirm the diagnosis of bile duct pathology. A 0.025-0.035-inch guidewire will then be inserted into the bile duct through the catheter. A dilating balloon (The controlled radial expansion (CRE) balloon dilation catheter, CRE balloon 5.5 cm (centimeter) in length, 1-1.2 cm/1.2-1.5 cm/1.5-2.0 cm in diameter) will be passed via the pre-positioned guidewire into the bile duct. Using fluoroscopic and endoscopic guidance, the balloon will be inflated with contrast medium up to the optimal size and duration (normally 5min (minutes)) after the waist on the balloon disappeared according to the patients' condition and tolerance.
Procedure: Endoscopic papillary balloon dilation
treatment of endoscopic papillary balloon dilation
Other Name: EPBD

Active Comparator: Endoscopic sphincterotomy

For EST group,endoscopic sphincterotomy(EST) will be done as large as possible with a pull type sphincterotome (The TRUEtome, Biliary sphincterotomy sphincterotome, Single-use sphincterotome CleverCut2V)

Other interventions: surgical intervention, endoscopic stenting, percutaneous transhepatic cholangiogram with balloon dilation

Procedure: Endoscopic sphincterotomy
treatment of endoscopic sphincterotomy
Other Name: EST




Primary Outcome Measures :
  1. Complete removal of common bile duct stones [ Time Frame: one year ]
    Successful bile duct clearance was defined as complete if the final cholangiogram revealed no more filling defects.


Secondary Outcome Measures :
  1. Evaluation of adverse events [ Time Frame: One week ]
    Adverse events were recorded according to the definitions and grading systems from the consensus of an American Society of Gastrointestinal Endoscopy Workshop. (P. B. Cotton, G. M. Eisen, L. Aabakken et al., "A lexicon for endoscopic adverse events: report of an ASGE workshop," Gastrointestinal Endoscopy, vol. 71, no. 3, pp. 446-454, 2010.)



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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668081


Contacts
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Contact: Hoi Hung Chan, MD, PhD +886-7-342-2121 ext 2137 hoihungchan@gmail.com
Contact: Tzung Jiun Tsai, MD +886-7-342-2121 ext 2075 medfungi@gmail.com

Locations
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Taiwan
Kaohsiung Veterans General Hospital. Recruiting
Kaohsiung, Taiwan, 386
Contact: Hoi Hung Chan, MD, PhD    +886-7-342-2121 ext 2137    hoihungchan@gmail.com   
Contact: Tzung Jiun Tsai, MD    +886-7-342-2121 ext 2075    medfungi@gmail.com   
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Study Chair: Hoi Hung Chan, MD, PhD Kaohsiung Veterans General Hospital.
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Responsible Party: Hoi-Hung Chan, associate professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02668081    
Other Study ID Numbers: VGHKS15-CT7-13
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Keywords provided by Hoi-Hung Chan, Kaohsiung Veterans General Hospital.:
Endoscopic sphincterotomy
Endoscopic papillary balloon dilation
Metagenomics
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases