|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
8 February 2016 |
|
Main ID: |
NCT02668081 |
|
Date of registration:
|
08/01/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Comparing the Effects of EST and EPBD in Patients With Acute Biliary Pancreatitis
|
|
Scientific title:
|
Prospective Randomized Study Comparing the Effects of Endoscopic Sphincterotomy (EST) and Endoscopic Papillary Balloon Dilation (EPBD) in Patients With Acute Biliary Pancreatitis (ABP) |
|
Date of first enrolment:
|
January 2016 |
|
Target sample size:
|
39 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02668081 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Taiwan
| | | | | | | |
|
Contacts
|
|
Name:
|
Hoi Hung Chan, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Kaohsiung Veterans General Hospital. |
|
|
Name:
|
Hoi Hung Chan, MD, PhD |
|
Address:
|
|
|
Telephone:
|
+886-7-342-2121 |
|
Email:
|
hoihungchan@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Hoi Hung Chan, MD, PhD |
|
Address:
|
|
|
Telephone:
|
+886-7-342-2121 |
|
Email:
|
hoihungchan@gmail.com |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion 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
Age minimum:
20 Years
Age maximum:
100 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Acute Biliary Pancreatitis
|
|
Intervention(s)
|
|
Procedure: Endoscopic papillary balloon dilation
|
|
Procedure: Endoscopic sphincterotomy
|
|
Primary Outcome(s)
|
|
Complete removal of common bile duct stones
[Time Frame: one year]
|
|
Secondary Outcome(s)
|
|
Evaluation of adverse events
[Time Frame: One week]
|
|
Secondary ID(s)
|
|
VGHKS15-CT7-13
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|