PancreatitisNCT06452875
PRIMARY NEEDLE KNIFE FISTULOTOMY
An observational study of Pancreatitis, run by University of Minho at 1 site in Portugal.
Trial summary
Evaluate the outcomes of NKF as an initial method for biliary access. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Primary Needle Knike Fistulotomy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2021to 31 Dec 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * ERCP with indication for biliary access * Naïve papilla (excluding flat or diverticular papillae according to Viana's classification)
Who may be able to join
- ERCP with indication for biliary access
- Naïve papilla
Who cannot join
- Patients unable to sign or understand the informed consent
- Patients with surgically altered anatomy
- Patients with tumors of the papilla
- Previous sphincterotomy
- Spontaneous papillary fistula
- Papilla not visualized
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PRIMARY NEEDLE KNIFE FISTULOTOMY FOR BILIARY CANNULATION IN A CONSECUTIVE GROUP OF PATIENTS
Evaluate the outcomes of NKF as an initial method for biliary access.
Read the 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 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
- Pancreatitis
- Being tested
- Primary Needle Knike Fistulotomy
- Keywords
- ERCP, Biliary cannulation, Needle-knife fistulotomy, Standard cannulation methods
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Needle Knike FistulotomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Comparison of adverse event rate between the two strategies
Measured: 30 days from the procedure
Technical success
Comparison of technical success between the two strategies
Measured: 1 day (same day of the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Lopes, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452875
- Sponsor's protocol ID
- 30/2021
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIMARY NEEDLE KNIFE FISTULOTOMY FOR BILIARY CANNULATION IN A CONSECUTIVE GROUP OF PATIENTS
- ClinicalTrials.gov ID
- NCT06452875
- Acronym / sponsor ID
- 30/2021
- Conditions
- Pancreatitis
- Keywords
- ERCP, Biliary cannulation, Needle-knife fistulotomy, Standard cannulation methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * ERCP with indication for biliary access * Naïve papilla (excluding flat or diverticular papillae according to Viana's classification)
Key inclusion criteria (2 listed)
- ERCP with indication for biliary access
- Naïve papilla
Key exclusion criteria (6 listed)
- Patients unable to sign or understand the informed consent
- Patients with surgically altered anatomy
- Patients with tumors of the papilla
- Previous sphincterotomy
- Spontaneous papillary fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Needle Knike FistulotomyAfter 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. | Procedure or surgery | – |
Primary outcome
Adverse events
Time frame: 30 days from the procedure
Comparison of adverse event rate between the two strategies
Technical success
Time frame: 1 day (same day of the procedure)
Comparison of technical success between the two strategies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, run by University of Minho at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 30 days from the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.