Effect of pancreatic duct stenting before common bile duct (CBD) cannulation for preventing post endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients attending in Firoozgar hospital
Pancreatitis is one of the main complications of ERCP by the 5-15% incidence. It seems that the inducing factor is problem in pancreatitis due to drainage. The aim of this study is the comparison incidence of post-ERCP pancreatitis among intervention and control groups. This is a single blind balanced controlled-trial that will be done in Firoozgar hospital by 96 samples. The patients who had the pancreatitis before ERCP will be excluded and all of patients who are eligible for ERCP implementation will be included in study. The primary outcome is the incidence of pancreatitis in both groups of study. The allocations of intervention and control groups are non-random and patients will be blind from type of intervention. The baseline characteristics are age, sex and serum amylase. The descriptive analysis, Chi-Square tests and logistic regression will be used for data analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201018575N1
Registration date:2013-06-24, 1392/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-24, 1392/04/03
Registrant information
Name
Hossein Ajdarkosh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1382
Email address
ajdarkosh1345@yahoo.com
Recruitment status
Recruitment complete
Funding source
The required tests are done in the hospital. The tests are needed in each case even without stent. The using stents are Endoflex made in German; that the cost of it would be asked from the annually income of research center.
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pancreatic duct stenting before common bile duct (CBD) cannulation for preventing post endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients attending in Firoozgar hospital
Public title
Effect of stent in pancreatic duct for preventing pancreatitis complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are: 1- Difficult cannulation that takes more than 15 minutes time; 2- Precut in vater ampulla while endoscopic retrograde cholangiopancreatography (ERCP); 3- Oddi sphincter dysfunction; 4- Three times duct catheterization with guide; 5- One time duct catheterization with catheter; 6- Duct contrast injection for patients who had at least one above criteria.
The main exclusion criteria are patients who have pancreatitis before intervention.
In this situation, the diagnosis of induced pancreatitis from ERCP is difficult.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
We will study two groups that the ERCP will be done for both of them but only for one group (as Intervention group) put stent. Both of putting and no putting of stent have been approved theoretically and practically. The main goal of this study is the comparison incidence of post-ERCP pancreatitis among intervention and control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
The central headquarters building, Iran University of Medical Sciences, The corner of Milad hospital, Hemmat highway, Tehran
City
Tehran
Postal code
Approval date
2012-04-20, 1391/02/01
Ethics committee reference number
90-04-12-16167-51615
Health conditions studied
1
Description of health condition studied
Common Bile Duct (CBD) stone
ICD-10 code
K80.5
ICD-10 code description
Calculus of bile duct without cholangitis or cholecystitis
Primary outcomes
1
Description
Pancreatitis
Timepoint
Patient's Amylase: 1- before ERCP. 2- during 6 and 18 hours after ERCP / after ERCP symptoms in patients are examined and investigated by a physician.
Method of measurement
According to serum amylase measurement and symptoms such as abdominal pain
2
Description
Putting stents in the pancreatitis duct
Timepoint
While bile duct cannulation in patients having inclusion criteria
Method of measurement
Intraoperative observation
Secondary outcomes
1
Description
Serum amylase
Timepoint
Before ERCP, within 6 and 18 hours post ERCP
Method of measurement
The patients' blood sampling (Mg/ dl)
Intervention groups
1
Description
In the intervention group, according to the accidental cannulation of pancreatic duct, a plastic stent 5cm and 5f (French) is placed in the pancreatic duct, and then ERCP will be done. In the control group, standard ERCP will be done (without putting stent). Stent will be done.
Category
Prevention
2
Description
In the control group, standard ERCP without stenting is done, and the results would be compared with the case group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Hossein Ajdarkosh
Street address
Firoozgar hospital, Behafarin St., Valiasr Sq., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyyed- Abbas Motevallian
Street address
The central headquarters building, Iran University of Medical Sciences, The corner of Milad hospital, Hemmat highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran 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
Firoozgar Hospital
Full name of responsible person
Hossein Ajdarkosh
Position
Gastroenterologist
Other areas of specialty/work
Street address
Firoozgar hospital, Behafarin St., Valiasr Sq.
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1633
Fax
+98 21 8214 1633
Email
ajdarkosh1345@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Firoozgar hospital
Full name of responsible person
Hossein Ajdarkosh
Position
Gastroenterologist
Other areas of specialty/work
Street address
Firoozgar hospital, Behafarin St., Valiasr Sq.
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1633
Fax
+98 21 8214 1633
Email
ajdarkosh1345@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Firoozgar hospital
Full name of responsible person
Hossein Ajdarkosh
Position
Gastroenterologist
Other areas of specialty/work
Street address
Firoozgar hospital, Behafarin St., Valiasr Sq.
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1633
Fax
+98 21 8214 1633
Email
m4_setareh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)