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

NCT02668081 | Unknown DMC

• 1 other identifier: VGHKS15-CT7-13
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Biliary Pancreatitis

Keywords

Endoscopic sphincterotomy; Endoscopic papillary balloon dilation; Metagenomics

Outcome Measures

Primary Outcomes (1)

• Complete removal of common bile duct stones

  Successful bile duct clearance was defined as complete if the final cholangiogram revealed no more filling defects.

  one year

Secondary Outcomes (1)

• Evaluation of adverse events

  One week

Study Arms (2)

Endoscopic papillary balloon dilation

EXPERIMENTAL

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

Endoscopic sphincterotomy

ACTIVE COMPARATOR

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

Interventions

Endoscopic papillary balloon dilation PROCEDURE

treatment of endoscopic papillary balloon dilation

Also known as: EPBD

Endoscopic papillary balloon dilation

Endoscopic sphincterotomy PROCEDURE

treatment of endoscopic sphincterotomy

Also known as: EST

Endoscopic sphincterotomy

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with acute gallstone pancreatitis and fulfill any two items from a to c, plus one item in d, and e:
• abdominal pain typical of pancreatitis;
• elevation of serum amylase and/or lipase up to three times above normal;
• imaging studies (abdominal ultrasound or abdominal computed tomography) showed evidence of pancreatitis
• 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;
• exclude other causes of acute pancreatitis.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital.

Kaohsiung City, 386, Taiwan

RECRUITING

MeSH Terms

Interventions

Sphincterotomy, Endoscopic

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Minimally Invasive Surgical Procedures; Sphincterotomy; Myotomy

Study Officials

• Hoi Hung Chan, MD, PhD

  Kaohsiung Veterans General Hospital.

  STUDY CHAIR

Central Study Contacts

Hoi Hung Chan, MD, PhD

CONTACT

+886-7-342-2121; hoihungchan@gmail.com

Tzung Jiun Tsai, MD

CONTACT

+886-7-342-2121; medfungi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 29, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

TW (1)