Comparison the therapeutical outcomes between common bile duct (CBD) stenting and standard endoscopic treatment in patient with CBD stones and multiple gallbladder stones
Comparison the therapeutical outcomes between common bile duct (CBD) stenting and standard endoscopic treatment in patient with CBD stones and multiple gallbladder stones
Design
Randomized controlled trial, with two arm parallel group of 40 patients, will be enrolled between September 2018 and March 2019, and will follow for 1 month
Settings and conduct
In this research, 40 eligible patients needed endoscopic retrograde cholangiopancreatography 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 and control group will receive standard endoscopic retrograde cholangiopancreatography. Participants does not know the intervention type.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with CBD stones and multiple gallbladder stones. Exclusion criteria: history of bile duct surgery; history of stomach and duodenal surgery; history of cholecystectomy
Intervention groups
Intervention group: common bile duct stenting. Control group: standard endoscopic retrograde cholangiopancreatography
Main outcome variables
Stone migration from gallbladder to common bile duct
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161205031252N9
Registration date:2018-09-22, 1397/06/31
Registration timing:prospective
Last update:2018-09-22, 1397/06/31
Update count:0
Registration date
2018-09-22, 1397/06/31
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
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutical outcomes between common bile duct (CBD) stenting and standard endoscopic treatment in patient with CBD stones and multiple gallbladder stones
Public title
Common bile duct stenting treatment in patient with CBD stones and multiple gallbladder stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with CBD stones and multiple gallbladder stones
Exclusion criteria:
History of bile duct surgery
History of stomach and duodenal surgery
History of cholecystectomy
High risk for cardiovascular and respiratory events
Bleeding disorders
Radiotherapy history
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
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)
Single blinded
Blinding description
Participants does not know the allocation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Saheli street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2018-09-11, 1397/06/20
Ethics committee reference number
IR.MUQ.REC.1397.085
Health conditions studied
1
Description of health condition studied
Common bile duct stones
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
Stone migration from gallbladder to common bile duct
Timepoint
1 month after treatment
Method of measurement
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
Intervention groups
1
Description
Intervention group: Common bile duct stenting
Category
Treatment - Devices
2
Description
Control group: Standard Endoscopic retrograde cholangiopancreatography