Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380543
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-18
Brief Title:
ERCP Biliary Cannulation Success Using ESGE Algorithm
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Efficacy of ERCP Using ESGE Algorithm for Biliary Cannulation a Multicenter Prospective Italian Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BILINCE
Brief Summary:
Papillary cannulation attempts have been shown to be an independent predictor of post-ERCP pancreatitis PEP when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time In order to reduce complications the 2016 ESGE guideline recommends a precise sequence of alternative cannulation techniques to the primary guidewire approach before exceeding the stated limits However there are no published data about the routinary application of this biliary cannulation algorithm
The investigators hypothesised that the ESGE algorithm predicts an increased cannulation success Nevertheless its unclear if this benefit is also associated with a decreased risk of complications mainly post-procedural pancreatitis
The investigators hypothesised that the ESGE algorithm predicts an increased cannulation success Nevertheless its unclear if this benefit is also associated with a decreased risk of complications mainly post-procedural pancreatitis
Detailed Description:
Multicenter prospective observational study which was promoted by SIED the Italian Society of Digestive Endoscopy involving Italian Centers that perform ERCP
The study was approved from the Ethics Committee in 2020 with an expected enrollment of 800 patients over three years with the potential to enroll patients for an extended period of time
Each Center have to enroll a minimum of 15 consecutive patients depending on the number of enrolling centers
Each patient need to undergo ERCP by using the different cannulation techniques reported in the ESGE algorithm which are numbered from 1 easy cannulation to 9 difficult cannulation
Digital data entry RedCap application are divided in three part 1 before ERCP patient demographics indications for ERCP the degree of anesthetic risk ASA 1-3 any prophylactic therapy for pancreatitis any assumptioninterruption of anti-platelet andor anti-coagulant drugs the type of sedation 2 ERCP cannulation details according to ESGE algorithm difficulty and duration of the procedure final diagnosis expertise of the endoscopist 3 After ERCP early and at 30-days complications defined and graded according to the Cotton classification
The study was approved from the Ethics Committee in 2020 with an expected enrollment of 800 patients over three years with the potential to enroll patients for an extended period of time
Each Center have to enroll a minimum of 15 consecutive patients depending on the number of enrolling centers
Each patient need to undergo ERCP by using the different cannulation techniques reported in the ESGE algorithm which are numbered from 1 easy cannulation to 9 difficult cannulation
Digital data entry RedCap application are divided in three part 1 before ERCP patient demographics indications for ERCP the degree of anesthetic risk ASA 1-3 any prophylactic therapy for pancreatitis any assumptioninterruption of anti-platelet andor anti-coagulant drugs the type of sedation 2 ERCP cannulation details according to ESGE algorithm difficulty and duration of the procedure final diagnosis expertise of the endoscopist 3 After ERCP early and at 30-days complications defined and graded according to the Cotton classification
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None