Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2021-01-01
2023-12-31
Brief Summary
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Detailed Description
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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 Fisher´s 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 \<0.05. 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Primary Needle Knike Fistulotomy
After verifying the eligibility of the papillary morphology (excluding flat or diverticular papillae according to Viana's classification), access to the bile duct will be initiated using the primary needle knife fistulotomy technique. After the first contact of the needle knife with the papilla, the endoscopist will have a total of 8 minutes, after which he can change to other cannulation techniques (eg standard cannulation methods through the papillary orifice) or even stop the procedure.
During ERCP all patients will be submitted to PEP prophylaxis with indomethacin. Also as a prophylactic PEP measure a pancreatic stent will be placed whenever there is cannulation or opacification of the Wirsung duct. For the purpose of this study, a dedicated form (attached) will be created with the various variables to be analyzed.
Eligibility Criteria
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Inclusion Criteria
* Naïve papilla
Exclusion Criteria
* Patients with surgically altered anatomy
* Patients with tumors of the papilla
* Previous sphincterotomy
* Spontaneous papillary fistula
* Papilla not visualized
18 Years
ALL
Yes
Sponsors
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University of Minho
OTHER
Responsible Party
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Luis Lopes
PhD
Locations
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ULS Nordeste
Bragança, , Portugal
Countries
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Other Identifiers
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30/2021
Identifier Type: -
Identifier Source: org_study_id
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