Comparison the therapeutical outcomes between CBD stenting and standard endoscopic treatment in large (grater than 15mm in diameter) and multiple (more than 3) CBD stones
The aim of the study is to compare clinical outcome of CBD stenting and standard endoscopic treatment in large(more than 15mm in diameter) or multiple CBD stones.This is a mono centric doble blinded randomized clinical trial. Patients with large or multiple CBD stones enroll the study and in case of recent surgery on bile duct, exclude the study.64 patients will divide in 2 groups randomly, one will receive standard endoscopic treatment and the other will undergo CBD stenting. Stents will be removed within 2 months. clinical outcomes including success rate, pancreatitis, cholangitis , reduction in number and size of stones, isolated pain and rupture will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020831252N4
Registration date:2017-11-02, 1396/08/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-02, 1396/08/11
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
Qom University of Medical Sciences
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2018-03-22, 1397/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutical outcomes between CBD stenting and standard endoscopic treatment in large (grater than 15mm in diameter) and multiple (more than 3) CBD stones
Public title
Comparison of CBD stenting and standard endoscopic treatment in large and multiple CBD stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: CBD stone with a diameter greater than 15mm; More than 3 stones in CBD
Exclusion criteria: History of recent surgery on bile ducts; History of gasterectomy; History of duodenal stricture; Patients who don not fill the informed concept form
Age
From 18 years old to 80 years old
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
Blinding (investigator's opinion)
Single blinded
Blinding description
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
Postal code
3716987366
Approval date
2015-11-11, 1394/08/20
Ethics committee reference number
IR.MUQ.REC.1394.133
Health conditions studied
1
Description of health condition studied
CBD stones
ICD-10 code
K80.5, K80
ICD-10 code description
Calculus of bile duct without cholangitis or cholecystitis, Calculus of bile duct with cholecystitis, Calculus of bile duct with cholangitis
Primary outcomes
1
Description
Common bile duct clearing
Timepoint
2 months after CBD stenting
Method of measurement
By ERCP
Secondary outcomes
1
Description
Chollangitis
Timepoint
After ERCP
Method of measurement
According to Charcot's triad including abdominal pain, serum bilirubin measurement and core body temperature measurement.
2
Description
Pancreatitis
Timepoint
After ERCP
Method of measurement
Serum Amylase level measurement
3
Description
Bile ducts perforation
Timepoint
During ERCP
Method of measurement
By ERCP
4
Description
Reduction in stones size
Timepoint
2 months after CBD stenting
Method of measurement
By ERCP
5
Description
Reduction in stone number
Timepoint
2 months after CBD stenting
Method of measurement
By ERCP
6
Description
Isolated pain
Timepoint
After ERCP
Method of measurement
Patient's statements
Intervention groups
1
Description
Common bile duct stenting
Category
Treatment - Devices
2
Description
Standard endoscopic treatment by Endoscopic papillary balloon dilatation
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology and Hepatology Disease Research Center, Qom University of Medical Sciences
Full name of responsible person
Dr Ahmad Hormati
Street address
Gastroenterology and Hepatology Disease Research Center Qom University of Medical Science, Shahid Beheshti Hospital, Qom
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr Ahmad Hormati
Street address
Gastroenterology and Hepatology Disease Research Center Qom University of Medical Science, Shahid Beheshti Hospital
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gastroenterology and Hepatology Disease Research Center, Qom University of Medical Sciences
Full name of responsible person
Dr Ahmad Hormati
Position
Assistant Professor of Gastroenterology
Other areas of specialty/work
Street address
Gastroenterology and Hepatology Disease Research Center, Shahid Beheshti Hospital, Qom
City
Qom
Postal code
3719964794
Phone
+98 25 3612 2053
Fax
+98 25 3612 2053
Email
hormatia@yahoo.com
Web page address
http://qddrc.muq.ac.ir/index.aspx
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gastroenterology and Hepatology Disease Research Center Qom University of Medical Sciences
Full name of responsible person
Dr Ahmad Hormati
Position
Assistant Professor of Gastroenterology
Other areas of specialty/work
Street address
Gastroenterology and Hepatology Disease Research Center Qom University of Medical Science, Shahid Beheshti Hospital, Qom
City
Qom
Postal code
3719964797
Phone
+98 25 3612 2053
Fax
+98 25 3612 2053
Email
hormatia@yahoo.com
Web page address
http://qddrc.muq.ac.ir/index.aspx
Person responsible for updating data
Contact
Name of organization / entity
Gastroenterology and Hepatology Disease Research Center, Qom University of Medical Sciences
Full name of responsible person
Dr Ahmad Hormati
Position
Assistant Professor of Gastroenterology
Other areas of specialty/work
Street address
Gastroenterology and Hepatology Disease Research Center, Shahid Beheshti Hospital, Qom
City
Qom
Postal code
3719964797
Phone
+98 25 3612 2053
Fax
+98 25 3612 2053
Email
hormatia@yahoo.com
Web page address
http://qddrc.muq.ac.ir/index.aspx
Sharing plan
Deidentified Individual Participant Data Set (IPD)