Investigation of the efficacy of prophylactic pancreatic duct stenting in the prevention of post-ERCP-pancreatitis in patients with difficult common bile duct cannulation using double guide wire technique
Investigating the effect of prophylactic pancreatic duct stenting in preventing pancreatitis after ERCP and comparing it with the group that did not undergo stenting.
Design
A clinical trial with two parallel groups, one side blind and on 238 patients, the trial phase is not applicable for this study. Randomization based on random blocks
Settings and conduct
All patients who are referred to Taleghani Hospital in Tehran for the first time for ERCP and who meet the criteria for difficult biliary cannulation and who have experienced at least one unintentional PD cannulation will be included in this study. The degree of difficulty of biliary cannulation is graded as grade 1 for easy cannulation, grade 2 for cannulation with moderate difficulty, and grade 3 for difficult cannulation. Patients with grade 2 and 3 difficult cannulation are subjected to biliary drainage techniques including DGW, TPS and OGW. Then, they are randomly targeted in the PDS inclusion or non-implementation experiment. A Boston Scientific 5cm-5Fr pigtail stent will be placed in all PD stenting candidates. Finally, patients will be followed for improvement of symptoms and occurrence of side effects during hospitalization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients suspected of acute biliary pancreatitis, biochemical findings and ultrasound findings. Exclusion criteria: cardiopulmonary disease and other systemic diseases that endanger anesthesia
Intervention groups
In the first group (intervention), prophylactic bile duct stents will be implanted for patients. In the second group (control), patients will not be placed under the bile duct stent.
Main outcome variables
Cannulation success rate; Complications include pancreatitis, perforation, bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230314057717N3
Registration date:2023-07-05, 1402/04/14
Registration timing:prospective
Last update:2023-07-05, 1402/04/14
Update count:0
Registration date
2023-07-05, 1402/04/14
Registrant information
Name
Amir Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2540
Email address
amirsadaghi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the efficacy of prophylactic pancreatic duct stenting in the prevention of post-ERCP-pancreatitis in patients with difficult common bile duct cannulation using double guide wire technique
Public title
Investigating the effect of pancreatic duct stent in the prevention of pancreatitis after ERCP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute pancreatitis (increased amylase and lipase 3 times more than normal)
Patients with gallstones on ultrasound suspected to have CBD stones (symptomatic gallstone disease)
Biochemical findings (increased AST, ALP, ALT or bilirubin)
Ultrasound findings (diagnosis of stones or enlargement of the CBD) that indicate a CBD stone or blockage of the CBD
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
238
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two groups using the random block method. The number of blocks will be 4 and in each block three patients will be included in the study order. Random allocation of blocks of patients to two treatment groups will be done through Sealed Envelope online software. The randomized list of blocks is placed in sealed envelopes and will be provided to the endoscopist on a daily basis
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to avoid the bias of the analyst, he does not know which patient is in which group, and the patients' characteristics are provided to him in a coded form.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences Faculty of Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2022-09-20, 1401/06/29
Ethics committee reference number
IR.SBMU.MSP.REC.1401.308
Health conditions studied
1
Description of health condition studied
Bile duct disease
ICD-10 code
K83.1
ICD-10 code description
Obstruction of bile duct
Primary outcomes
1
Description
Incidence of pancreatitis after ERCP
Timepoint
6 hours after the procedure
Method of measurement
Blood Amylase and/or lipase 3 times higher than normal 24 hours after the procedure with abdominal pain
2
Description
Success rate of bile duct cannulation
Timepoint
At the time of cannulation by the endoscopist
Method of measurement
Visual diagnosis of the endoscopist by observing the cannulation process on the monitor
3
Description
Bleeding
Timepoint
During or after the procedure
Method of measurement
Clinical evidence of bleeding or hemoglobin drop
4
Description
Perforation of bile duct
Timepoint
During the procedure
Method of measurement
Clinical evidence of perforation of the lateral or medial wall of the bile duct
5
Description
Cholangitis
Timepoint
6 hours after the procedure
Method of measurement
When the bile duct becomes infected (abdominal pain and fever over 38 degrees)
Secondary outcomes
1
Description
Body temperature
Timepoint
4 hours after the completion of the procedure
Method of measurement
Thermometer
2
Description
Amylas
Timepoint
before the procedure and 3 hours after the procedure
Method of measurement
Blood test
3
Description
Lipas
Timepoint
before the procedure and 3 hours after the procedure
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Patients who undergo implantation of a 5cm-5Fr pigtail Boston Scientific stent in the pancreatic duct.
Category
Treatment - Devices
2
Description
Control group: Patients who do not undergo bile duct stenting
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Amir Sadeghi
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Phone
+98 912 501 6596
Email
amirsadeghimd@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 3277 6063
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gholamreza Noori
Position
Gastroenterologist assistant
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2540
Email
dr_noori11@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Sadeghi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2540
Email
amirsadeghimd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gholamreza Noori
Position
Gastroenterologist assistant
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2540
Email
dr_noori11@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The statistical analysis plan, study design and information on main outcomes will be shared
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Researchers, medical students, professors and doctors
Under which criteria data/document could be used
If used for further research and in compliance with the principle of referencing
From where data/document is obtainable
Responsible author Amir Sadeghi amirsadeghimd@yahoo.com
What processes are involved for a request to access data/document
Send the request to the responsible author and outline the reason for the request