Endoscopic Ultrasonography-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study

February 10, 2015 updated by: Samsung Medical Center

EUS-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study

Due to widespread use of cross-sectional imaging modalities, pancreatic cysts are common in abdominal image. These lesions encompass a wide spectrum, ranging from benign to malignant. The diagnosing specific type of cystic lesion is limited in spite of recent advances of diagnostic modalities. Surgical resection is generally recommended for malignant and potentially malignant lesions. However, surgical resection has significant morbidity and sometimes mortality. Recently, a few study of EUS-guided ethanol lavage for cystic tumors of the pancreas reported that complete resolution was achieved in only one-third of patients. Ethanol lavage of pancreatic cysts may be alternative method to surgical resection.

The purpose of this study is the double ethanol lavage is a safe and effective method for treatment in those with the indeterminate pancreas cysts.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

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

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients age 18 and older of any gender, ethnicity and race
  • Voluntary enrollment and ability to give written informed consent
  • Capable of safely undergoing endoscopy with deep sedation or general anesthesia
  • Indeterminate cystic lesion which was diagnosed in cross-sectional image (CT and MRI)
  • Pancreatic cystic lesion having uni- or oligo-locular (defined as having 2-6 locules within a cyst) and 2~4 cm in diameter

Exclusion Criteria:

  • Pancreatic cystic lesions which had the typical morphology of serous cystadenomas (i.e., honeycomb appearance) and pseudocysts (i.e., recent history of acute pancreatitis or parenchymal changes)
  • Pancreatic cystic lesions having communication between the cystic lesion and the main pancreatic duct according to endoscopic retrograde cholangiopancreatography and magnetic resonance cholangiopancreatography
  • Pancreatic cystic lesions having overt evidence of carcinomas, such as peripancreatic invasion
  • Patients with a bleeding tendency (prothrombin time > 1.5 international normalized ratio [INR] or platelet count < 50,000/μL).

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ethanol double lavage
Endoscopic ultrasonography-guided double ethanol lavage
Drug: Endoscopic ultrasonography-guided double ethanol lavage

A radial echoendoscope and a 22 gauge needle were then used for cyst fluid aspiration and ethanol lavage.

The 80 percent volume of cyst fluid was aspirated, and the pure ethanol was injected into the collapsed cyst until the original shape was restored. After 3-5 minutes, the reaspiration of the injected ethanol was then performed. The pure ethanol was reinjected into the collapsed cyst, followed by reaspiration of maximal possible volume for 3-5 minutes.

Other Names:
  • Ethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Subjects with Complete or Partial response of treatment
Time Frame: 1 year after final treatment
Complete or partial response of treatment will be defined by the presence of a treated cystic structure, and its volume and maximum diameter in cross-sectional imaging studies (CT, MR)
1 year after final treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of adverse events after treatment
Time Frame: 1 year after final treatment
Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability
1 year after final treatment

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Jong-Kyun Lee, M.D., Ph.D., Division of Gastroenterology, Samsung Medical Center

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

October 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-06-058-001

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.

Clinical Trials on Pancreatic Mucinous-Cystic Neoplasm

Clinical Trials on Endoscopic ultrasonography-guided double ethanol lavage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe