Influence of Vater's Ampulla Morphology on ERCP

July 26, 2020 updated by: Luis Lopes, University of Minho

Influence of Vater's Ampulla Morphology on Biliary Cannulation Rate, Complications and Advanced Biliary Cannulation Techniques

Determine the influence of the papilla's morphology on the various outcomes of endoscopic retrograde cholangiopancreatography (ERCP), namely on the success of biliary cannulation, on complications, and on the need to use rescue cannulation techniques;

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

  1. Background

    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.

    Since the first description of the "Vater's papilla" by Abraham Vater in 17209, the variability in papillary morphology has been widely recognized10. The use of high quality digital images has led to a clear need and desire to create an endoscopic classification based on the papilla's morphology. During the last decade, several authors have proposed different classifications in order to predict the success of cannulation, complications and the need for more advanced cannulation techniques11,12,13,14,15. However, all the proposed classifications, with the exception of one, fail because they have not been submitted to a validation process. The only validated one is the proposed by Haraldsson13, which still has the drawback of not incorporating some of the papillary morphologies.

    Given the need, our research group created a new classification (entitled "Viana Classification") that not only incorporates more morphologies but was also validated in due course.

    Hence, the next step is to explore the potential implications of papillary morphology on the success of biliary cannulation, complications resulting from ERCP and the need to use rescue techniques (fistulotomy and double-guidewire cannulation) in the event of failure of the standard cannulation.

  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 (the exact same exams that the patient would do if there wasn't this study). 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.

    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 from this study will contribute to a better understanding of the influence of papillary morphology on cannulation difficulty. In the event of demonstrating that some morphologies imply greater difficulty in cannulation, strategies may be created, such as the use of ab initio rescue techniques, in order to improve the results of ERCP, namely the cannulation rate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Portugal
      • Viana do Castelo, Portugal, 4904-858
        • Recruiting
        • Santa Luzia Hospital, Unidade Local de Saúde do 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All individuals referred for CPRE in the Digestive Endoscopy Unit of the Santa Luzia Hospital, Unidade Local de Saúde do Alto Minho, will be invited to participate in the study, in the period between June 1, 2020 to June 1, 2022.

Description

We will conduct a prospective observational study.

Inclusion Criteria:

  • ERCP with indication for biliary access
  • Naïve papilla

Exclusion Criteria:

  • Patients unable to 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation between the morphology of the Vater's Ampulla and biliary cannulation difficulty
Time Frame: 1 day
Correlation between the morphology of the Papilla de Vater, defined by the Viana classification, and the difficulty of cannulation between experts and other endoscopists (initiates and non-expert specialists)
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between the morphology of the Vater's Ampulla, and complications, and need/success of advanced cannulation techniques
Time Frame: up to 30 days
Correlation between the morphology of the Vater's Ampulla, defined by the Viana classification, and complications, and need/success of advanced cannulation techniques (fistulotomy and double-guidewire cannulation)
up to 30 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minho

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 30/2020

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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