Prospective Comparison Between Ultra Early NKF Versus Standard Cannulation Alone

August 9, 2021 updated by: Luis Lopes, University of Minho

Prospective Comparison Between Ultra Early NKF Versus Standard Cannulation Alone in a Group of High and Low Risk of Pep, Submitted to Pep Prophylaxis

Compare the ultra early fistulotomy strategy with standard cannulation methods for accessing the bile duct during endoscopic retrograde cholangiopancreatography (ERCP)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Introduction

    Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced procedure which is widely used in the diagnosis and treatment of a variety of benign and malignant pancreatobiliary disorders1,2,3,4,5.

    Selective cannulation of the common bile duct (CBD) is the most important and challenging step in a biliary endoscopic retrograde cholangiopancreatography6,7. However, in the first ERCP, even in experienced hands, biliary cannulation may fail in up to 15 % - 35 % of cases when using standard methods alone8. In this subset of patients, additional cannulation techniques are needed to access the CBD in order to continue with the ERCP.

    Precut is the most common strategy used by experienced endoscopists, when conventional methods have failed7. Needle knife fistulotomy (NKF) and conventional precut are the two most common variants. Recently published guidelines recommend opting for NKF, as evidence suggests a lower risk of adverse events, especially pancreatitis, when used early in the biliary cannulation algorithm7,9.

    Technically NKF is the creation of an artificial fistula between the most protuberant portion of the papilla, which represents the intraduodenal portion of the CBD and the biliary tract by using a diathermic cutter of the needle type6,10,11,12,13,14,15,16,17,18. Its big advantage over conventional precut is that it avoids the contact of the cutting device with the papillary orifice and therefore avoiding direct thermal injury to the pancreatic duct.

    Although NKF was originally developed as a rescue technique, to be used after previous failed standard cannulations attempts, it is being increasingly used at an early stage during ERCP. Given its safety and feasibility some authors even advocate, the once unreasonable, primary use without previous standard cannulation attempts10,11,19,20.

  2. 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.

  3. 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.

  4. 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.

    A sample of 334 (167 in each group) patients will provide 80% power to detect a difference of 5% in pancreatitis rates between the two groups based on a chi-square test, assuming a pancreatitis rate of 1% among primary fistulotomy, 6 and a one-tailed alpha of 0.05.

    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)

  5. 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 Type

Interventional

Enrollment (Anticipated)

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
      • Viana do Castelo, Portugal, 4904-858
        • Recruiting
        • Santa Luzia Hospital, ULS Alto Minho
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

From June 1, 2020 to June 1, 2022, all individuals referred for ERCP in the Digestive Endoscopy Unit of Santa Luzia Hospital (Unidade Local de Saúde do Alto Minho) will be invited to participate in the study.

Inclusion Criteria:

  • ERCP with indication for biliary access
  • Naïve papilla

Exclusion Criteria:

  • Flat papillas
  • Intradiverticular / Diverticular border papillas
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultra Early NKF group
Patients submitted to Ultra early NKF in a consecutive fashion by an expert endoscopist
Procedure: Cannulation technique

Participants in the ultra early NKF group will be submitted to 2 standard cannulation attempts (2 contacts with the papilla) before starting NKF. If any of these 2 attemps is successful, NKF won't take place. If NKF is indeed performed and cannulation is not achieved within 8 minutes, the endoscopist is free to perform techniques other than NKF. On the other hand, participants in the standard cannulation group in which cannulation is not achieved within 8 minutes can cross-over to other advanced cannulation techniques (e.g. NKF). For ethical reasons we choose to exclude flat and intradiverticular/diverticular border papillas.

During ERCP all participants will be submitted to PEP prophylaxis with rectal indomethacin. A pancreatic stent will be placed whenever there is cannulation or opacification of the Wirsung duct.

For the purposes of the study, a dedicated form (attached) will be created with the various variables to be analyzed
No Intervention: Standard cannulation techniques group (including double-guidewire-assisted cannulation)
Patients submitted to standard cannulation techniques (including double-guidewire-assisted cannulation) in a consecutive fashion by an expert endoscopist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 30 days from the procedure
Comparison of adverse event rate between the two strategies
30 days from the procedure
Technical success
Time Frame: 1 day (same day of the procedure)
Comparison of technical success between the two strategies
1 day (same day of the procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event rate among sub groups
Time Frame: 30 days from the procedure
Comparison of adverse event rate among sub groups (high and low risk of pancreatitis)
30 days from the procedure
Technical success among sub groups
Time Frame: 1 day (same day of the procedure)
Comparison of technical success rate among sub groups (high and low risk of pancreatitis)
1 day (same day of the procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minho

Collaborators

Unidade Local de Saúde do Alto Minho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 26, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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