Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452875
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Brief Title:
PRIMARY NEEDLE KNIFE FISTULOTOMY
Sponsor:
University of Minho
Organization:
University of Minho
Study Overview
Official Title:
PRIMARY NEEDLE KNIFE FISTULOTOMY FOR BILIARY CANNULATION IN A CONSECUTIVE GROUP OF PATIENTS
Status:
COMPLETED
Status Verified Date:
2024-06
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:
None
Brief Summary:
Evaluate the outcomes of NKF as an initial method for biliary access
Detailed Description:
Introduction
A previous feasibility study has suggested that needle knife fistulotomy NFK as an initial method for biliary access in patients with stones is associated with high levels of success and low rate of complications This study evaluated the outcomes of NKF as an initial method for biliary access in a large number of patients with any type of biliary pathology tumors and stones on the basis of success rate complications and factors associated with success and complications
Financial resources
All participants included in this study will perform ERCP laboratory tests and other complementary diagnostic tests after a duly justified medical prescription Therefore there are no additional costs or consumption of hospital resources
Ethical considerations
In this study participants will be included after informed consent Anonymity and confidentiality will be safeguarded by assigning an individual numeric code It will also be explained the possibility of withdrawing from the study at any time with the guarantee of the total elimination of data All researchers involved in the study will adhere to the Rules of Ethical Conduct and Best Practices in order to comply with the precepts of the Declaration of Helsinki the Convention on Human Rights and Biomedicine the guidelines of the Council for International Organizations of Medical Sciences and the Guide to Good Clinical Practice
Statistical analysis
Qualitative variables will be summarized using absolute and relative frequencies and quantitative variables will be summarized using the mean and standard deviation or the median and interquartile range depending on their distribution profiles The normality of the quantitative variables will be assessed using the histogram distribution
Relations between categorical variables will be assessed using a chi-square test and Fishers exact test Differences between two or more groups of independent non-normally distributed quantitative variables will be evaluated using a Kruskal-Wallis test
To explain the risk of pancreatitis a binomial logistic regression model with multiple predictors will be performed
The null hypothesis will be rejected when the test statistics p-values are less than 005 Statistical analysis sample size calculation and graphics will be performed using Stata software StataCorp 2015 Stata Statistical Software Release 14 College Station StataCorp LP
Expected results
The results of this study will contribute to a better understanding of what is the best algorithm to follow when performing an ERCP
A previous feasibility study has suggested that needle knife fistulotomy NFK as an initial method for biliary access in patients with stones is associated with high levels of success and low rate of complications This study evaluated the outcomes of NKF as an initial method for biliary access in a large number of patients with any type of biliary pathology tumors and stones on the basis of success rate complications and factors associated with success and complications
Financial resources
All participants included in this study will perform ERCP laboratory tests and other complementary diagnostic tests after a duly justified medical prescription Therefore there are no additional costs or consumption of hospital resources
Ethical considerations
In this study participants will be included after informed consent Anonymity and confidentiality will be safeguarded by assigning an individual numeric code It will also be explained the possibility of withdrawing from the study at any time with the guarantee of the total elimination of data All researchers involved in the study will adhere to the Rules of Ethical Conduct and Best Practices in order to comply with the precepts of the Declaration of Helsinki the Convention on Human Rights and Biomedicine the guidelines of the Council for International Organizations of Medical Sciences and the Guide to Good Clinical Practice
Statistical analysis
Qualitative variables will be summarized using absolute and relative frequencies and quantitative variables will be summarized using the mean and standard deviation or the median and interquartile range depending on their distribution profiles The normality of the quantitative variables will be assessed using the histogram distribution
Relations between categorical variables will be assessed using a chi-square test and Fishers exact test Differences between two or more groups of independent non-normally distributed quantitative variables will be evaluated using a Kruskal-Wallis test
To explain the risk of pancreatitis a binomial logistic regression model with multiple predictors will be performed
The null hypothesis will be rejected when the test statistics p-values are less than 005 Statistical analysis sample size calculation and graphics will be performed using Stata software StataCorp 2015 Stata Statistical Software Release 14 College Station StataCorp LP
Expected results
The results of this study will contribute to a better understanding of what is the best algorithm to follow when performing an ERCP
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