Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591364
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
Prevalence and Predictive Factors of Difficult Biliary Cannulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prevalence and Predictive Factors of Difficult Biliary Cannulation a Multicenter Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECABIDO
Brief Summary:
The main purpose of the study is to evaluate the prevalence of difficult biliary cannulation using endoscopic retrograde cholangiopancreatography ERCP according to the criteria defined by the European Society of Gastrointestinal Endoscopy ESGE and the American Society for Gastrointestinal Endoscopy ASGE as well as the predictive factors for this event in a prospective multicenter study Consecutive patients undergoing ERCP will be included in the study
We will also assess
Evaluate the failure of biliary cannulation in our setting Evaluate predictive factors for difficult cannulation and cannulation failure using ESGE criteria
Design an a priori predictive model for difficult cannulation and cannulation failure
Cost study record of materials used
We will also assess
Evaluate the failure of biliary cannulation in our setting Evaluate predictive factors for difficult cannulation and cannulation failure using ESGE criteria
Design an a priori predictive model for difficult cannulation and cannulation failure
Cost study record of materials used
Detailed Description:
All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study They will be informed by one of the investigators from each center and will sign an informed consent form A data collection sheet will be completed to record demographic data the indication for the procedure and technical variables
The procedures will be performed by endoscopists with at least 200 ERCPs and more than 5 years of experience All patients except in cases of allergy will receive 1 suppository of indomethacin or diclofenac before the procedure In cases of allergy pre-procedure hydration with Ringers lactate will be administered if there is no contraindication consider the protocol proposed by the ESGE 3 mLkghour during ERCP 20 mLkg as a bolus after ERCP and 3 mLkghour for 8 hours post-ERCP The use of a pancreatic stent should be considered when indicated
After the procedure patients will remain hospitalized for at least 24 hours in the hospital The patients medical record will be reviewed 7 days after the procedure to check for any adverse effects and a follow-up phone call will be made to detect any adverse effects
Initially a pilot study will be conducted with 600 patients assessing based on the results-that is the percentage of patients with difficult cannulation and the number of independent variables associated in the multiple logistic regression-the need to include a larger number of patients For each variable included in the multiple logistic regression analysis 8 to 10 cases of patients with difficult cannulation would be required
The procedures will be performed by endoscopists with at least 200 ERCPs and more than 5 years of experience All patients except in cases of allergy will receive 1 suppository of indomethacin or diclofenac before the procedure In cases of allergy pre-procedure hydration with Ringers lactate will be administered if there is no contraindication consider the protocol proposed by the ESGE 3 mLkghour during ERCP 20 mLkg as a bolus after ERCP and 3 mLkghour for 8 hours post-ERCP The use of a pancreatic stent should be considered when indicated
After the procedure patients will remain hospitalized for at least 24 hours in the hospital The patients medical record will be reviewed 7 days after the procedure to check for any adverse effects and a follow-up phone call will be made to detect any adverse effects
Initially a pilot study will be conducted with 600 patients assessing based on the results-that is the percentage of patients with difficult cannulation and the number of independent variables associated in the multiple logistic regression-the need to include a larger number of patients For each variable included in the multiple logistic regression analysis 8 to 10 cases of patients with difficult cannulation would be required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None