Endoscopic Ultrasonography-guided Double Ethanol Lavage For Pancreatic Cysts: A Prospective Cohort Study

Study Overview

Endoscopic Ultrasonography-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.

N/A

Pancreatic Mucinous-Cystic Neoplasm

DRUG: Endoscopic ultrasonography-guided double ethanol lavage

2014-06-058-001

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-08-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-02-10
First Submitted that Met QC Criteria 2014-08-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-02-12
First Posted (ESTIMATED) 2014-08-11	Results First Posted N/A	Last Verified 2014-07

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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.

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.

Primary Outcome Measures	Measure Description	Time Frame
Rate of Subjects with Complete or Partial response of 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	Measure Description	Time Frame
Incidence rate of adverse events after treatment	Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability	1 year after final treatment

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

Name: Jong-Kyun Lee, M.D., Ph.D.

Phone Number: 82-2-3410-3407

Email: jongk.lee@samsung.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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

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).

Collaborators and Investigators

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

Investigators

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

Publications

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

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record