The effect of adding ursodeoxycholic acid to common bile duct (CBD) stenting for treatment of large and multiple CBD stones
Design
Randomized controlled trial, with two arm parallel group of 64 patients, will be enrolled between September 2018 and March 2019, and will follow for 2 months.
Settings and conduct
In this research, 64 eligible patients needed common bile duct stenting referring to Qom gastroenterology clinic were chosen. Then, patients by block randomization were randomly divided into two control and intervention groups. The intervention group will receive common bile duct stenting with ursodeoxycholic acid capsule and control group will receive only common bile duct stenting. The study will be done without blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: common bile duct stone with a diameter greater than 15mm; More than 3 stones in common bile duct. Exclusion criteria: History of recent surgery on bile ducts; History of gasterectomy; History of duodenal stricture
Intervention groups
Control group: Common bile duct stenting. Intervention group: Common bile duct stenting with Ursodeoxycholic Acid capsule, 300 mg, oral, once daily, for two months
Main outcome variables
Common bile duct clearing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161205031252N8
Registration date:2018-08-29, 1397/06/07
Registration timing:prospective
Last update:2018-08-29, 1397/06/07
Update count:0
Registration date
2018-08-29, 1397/06/07
Registrant information
Name
Ahmad Hormati
Name of organization / entity
Qom university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2053
Email address
hormatia@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding ursodeoxycholic acid to common bile duct (CBD) stenting for treatment of large and multiple CBD stones
Public title
The effect of ursodeoxycholic acid for treatment of large and multiple common bile duct stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Common bile duct stone with a diameter greater than 15 mm
More than 3 stones in common bile duct
Exclusion criteria:
History of recent surgery on bile ducts
History of gasterectomy
History of duodenal stricture
Patients who do not fill the informed concept form
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be assigned to two groups of intervention and control by block randomization. For this purpose blocks of size 4 will be used. Six blocks will include BAAB, ABBA, BABA, BBAA, ABAB, AABB. To hide the random allocation, the numbered dark envelopes will be used, in which the group name is specified in the random sequence generated. Then, according to the order of entering samples, for the first patient the envelope number one is opened and the group will be identified until the end.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
No. 83, 4th alley, 1.1 alley, Safashahr Blvd
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2018-07-31, 1397/05/09
Ethics committee reference number
IR.MUQ.REC.1397.075
Health conditions studied
1
Description of health condition studied
CBD stones
ICD-10 code
K80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis
Primary outcomes
1
Description
Common bile duct clearing
Timepoint
2 months after CBD stenting
Method of measurement
By endoscopic retrograde cholangiopancreatography
Secondary outcomes
1
Description
Chollangitis
Timepoint
After endoscopic retrograde cholangiopancreatography
Method of measurement
According to Charcot's triad including abdominal pain, serum bilirubin measurement and core body temperature measurement
2
Description
Pancreatitis
Timepoint
After endoscopic retrograde cholangiopancreatography
Method of measurement
Serum amylase level measurement
3
Description
Reduction in stones size
Timepoint
Two months after common bile duct stenting
Method of measurement
By fluoroscopy during endoscopic retrograde cholangiopancreatography
4
Description
Reduction in common bile duct (CBD) stone number
Timepoint
Two months after CBD stenting
Method of measurement
By endoscopic retrograde cholangiopancreatography
Intervention groups
1
Description
Intervention group: Common bile duct stenting with Ursodeoxycholic Acid capsule, KoushanPharmed company, 300 mg, oral, once daily, for two months