EUS-guided Ablation of Pancreatic Cyst Neoplasms

December 12, 2024 updated by: AdventHealth

Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cyst Neoplasms

This is a registry that will maintain prospective data on the clinical outcomes of all patients with pancreatic cyst lesions who undergo EUS-guided alcohol ablation.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Visit 1 for all participants will consist of going over the Informed Consent form and talking with the patient about the study. If the patient agrees to participate, he/she will be asked to sign the form, and a copy will be given to him/her for his/her records. This will be conducted during the day of the endoscopic procedure before the participant is under anesthesia. The treatment provided will be standard-of-care that is offered to patients with pancreatic cyst lesions (PCL) interested in undergoing EUS-guided ethanol ablation.

An MRI of the abdomen will be obtained as baseline measure to determine the size of the pancreatic cyst and confirm diagnosis.

Prior to undertaking any ablation, the cyst fluid will be sampled at a prior EUS session to check for mucin, viscosity, carcinoembryonic antigen (CEA) (>200U/L=mucinous cyst), amylase and if required molecular marker analysis. Once a PCL is determined to have a malignant potential the patient will be selected for EUS-guided ablation. All patients will receive a dose of intravenous ciprofloxacin 500mg 30 minutes prior to the ablation. These evaluation and treatment measures are standard-of-care for any patient with pancreatic cyst lesion undergoing EUS-guided ethanol ablation.

Procedural Technique: All procedures will be undertaken using a curvilinear echoendoscope. Once a cyst is identified for ablation it will be punctured using a 22G needle. After subtotal evacuation of the cyst, injection is performed with a volume of alcohol that is equal to the quantity aspirated, and the cyst will be lavaged for 3 to 5 minutes, alternatively filling and emptying the cavity. The injected ethanol will then be evacuated at the end of lavage, leaving just enough fluid to outline the cavity. A second ablative agent such as paclitaxel is then injected and left in the cyst cavity; the volume injected should not exceed the volume of aspirated fluid. The needle tip must be carefully maintained within the cyst to avoid parenchymal injury or cyst wall leak. At the completion of the procedure, the needle will be removed from the cyst cavity. When a cyst is not restored to its original size during ethanol injection, vigorous lavage and aspiration must be avoided because of probable communication with the main pancreatic duct.

In patients with multi-loculated cysts, a single injection may not provide sufficient drug delivery to all locules within a cyst. It is important to determine the optimal angle at which the needle can be introduced into the maximum number of targeted locules. When all punctured locules cannot be visualized on endosonographic image, needle passage across a septation may be indicated. The simultaneous collapse of locules across the septum during cyst fluid evacuation and spread of echogenic bubbles across the septation during injection of ablative agents are indication of good distribution of the ablative agent into the locules. This is important as a missed locule may result in cyst regrowth and treatment failure. While additional needle passes through different angles may increase the effectiveness of cyst ablation it will also increase the incidence of adverse events. Therefore a second needle puncture may be considered only when the risk of adverse events appears low.

The relative effectiveness of the procedure is related to the degree of contact between the ablative agent and the cyst epithelium. However, it is important to maintain the needle in the visual plane and within the cyst cavity during the entire procedure. All techniques described above are standard-of-care treatment measures offered to patients undergoing EUS-guided ethanol ablation of pancreatic cysts.

Ablative agents:

  1. Ethanol: concentration of 80-99% may be used.
  2. Paclitaxel: Because of the high viscosity of its cosolvent (castor oil) the paclitaxel solution must be diluted 1:1 in 0.9% normal saline to yield a final dose concentration of 3mg/mL. However, if the agent is available in a less viscous format (polymeric micelle) it can be used without dilution (a dose concentration of 6mg/mL).

Follow-up:

  1. Patients will be admitted overnight for observation and kept nil by mouth. A complete blood count and serum amylase level will be checked the next day and patients will be discharged home if clinically well, with no evidence of pancreatitis or other adverse events and can tolerate a low fat diet. Patients will be prescribed oral ciprofloxacin 500 mg to be taken twice a day for three days. This will be standard-of-care follow-up.
  2. A CT of the abdomen will be obtained at 3 months to assess treatment response. If there is no change in size of the cyst, further CT scans will be scheduled at 3-month intervals with another attempt at EUS-guided cyst ablation. If there is complete or partial cyst resolution, follow-up CT scans will be obtained at 6-month intervals. If complete resolution is documented on two CT scans, then the patient will be scheduled for annual CT scans. This will be standard-of-care follow-up. 3. Patients with persistent or only partial cyst resolution despite two ablative treatment sessions will be referred to a pancreatic surgeon for consultation. If the patients are high-risk surgical candidates, surveillance by EUS and cross-sectional imaging will be continued per International Society of Pancreatology guidelines. This will be standard-of-care follow-up. 4. Definitions: Using multi-detector CT scans and specialized software the original volume (OV) of the cyst will be calculated by the radiologist. Complete resolution will be defined as the cyst being nonvisible or less than 5% of the OV on follow-up CT; Partial resolution of the cyst will be defined as decrease in size by 5-25% of the OV and the cyst will be defined as Persistent if > 25% the OV.

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 (Estimated)

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.
1000

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 Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Adventhealth

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

No

Sampling Method

Probability Sample

Study Population

Any male or female presenting to Florida Hospital Center for Interventional Endoscopy with a pancreatic cyst will be considered for this registry pending he/she meets inclusion/exclusion criteria.

Description

Inclusion Criteria:

  1. Benign branch-duct intraductal papillary mucinous neoplasm (IPMN) or mucinous cyst neoplasm (MCN) measuring >2 and up to 4cm in size and located in the head or body of the pancreas.
  2. Benign branch-duct IPMN or MCN measuring > 2 and up to 4cm in size and located in the tail of the pancreas in a high-risk surgical candidate.
  3. A branch-duct IPMN or MCN with high-risk features (mural nodule or enlarging in size) in a high-risk surgical patient.
  4. Indeterminate cyst lesions

Exclusion Criteria:

  1. Cysts measuring <2cm or >4cm.
  2. Multiloculated cysts (>4 locules).
  3. Cysts with vascular supply.
  4. Cysts communicating with the main pancreatic duct via an obvious side-branch measuring 2mm or more in diameter.
  5. Cysts with hypoechoic mass lesions that on fine needle aspiration (FNA)reveal malignant cells.
  6. Recent history of pancreatitis and EUS findings suggestive of a pseudocyst.
  7. Bleeding tendency; international normalized ratio (INR) >1.4 or platelet count <70,000.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Ablation of PCL
Patients with pancreatic cysts will undergo ablation using alcohol under EUS-guidance
Procedure: Ablation of PCL
All procedures are standard of care and will be undertaken using a curvilinear echoendoscope. The cyst will be punctured using a 22G needle and after subtotal evacuation of the cyst, injection is performed with a volume of alcohol that is equal to the quantity aspirated, and the cyst will be lavaged for 3 to 5 minutes. The injected ethanol will then be evacuated at the end of lavage, leaving just enough fluid to outline the cavity. A second ablative agent such as paclitaxel is then injected and left in the cyst cavity. At the completion of the procedure, the needle will be removed from the cyst cavity.
Other Names:
  • EUS-guided ablation of pancreatic cyst lesions (PCL)

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
This study will evaluate the clinical outcomes (effectiveness) of all patients with pancreatic cyst lesions undergoing EUS-guided ethanol ablation. This will include complete resolution of the pancreatic cyst lesion at the end of the treatment period.
Time Frame: Up to 12 months
Clinical outcomes
Up to 12 months

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.
AdventHealth

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Muhammad Hasan, MD, Adventhealth

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)

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, 2016

Primary Completion (Actual)

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.
December 12, 2024

Study Completion (Actual)

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.
December 12, 2024

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).
February 24, 2015

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.
April 20, 2015

First Posted (Estimated)

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.
April 21, 2015

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.
March 25, 2025

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.
December 12, 2024

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.
December 1, 2024

More Information

Terms related to this study

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.
  • 723324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A manuscript will be developed and submitted for publication upon study completion.

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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