Back to resultsEndoscopic Ultrasonography-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study
Primary Purpose
Pancreatic Mucinous-Cystic Neoplasm
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endoscopic ultrasonography-guided double ethanol lavage
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Mucinous-Cystic Neoplasm focused on measuring Cystic Tumors of the Pancreas, Endoscopic Ultrasound, Ethanol
Eligibility Criteria
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).
Sites / Locations
- Samsung Medical CencerRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ethanol double lavage
Arm Description
Endoscopic ultrasonography-guided double ethanol lavage
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02213419
First Posted
August 7, 2014
Last Updated
February 10, 2015
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02213419
Brief Title
Endoscopic Ultrasonography-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study
Official Title
EUS-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Mucinous-Cystic Neoplasm
Keywords
Cystic Tumors of the Pancreas, Endoscopic Ultrasound, Ethanol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ethanol double lavage
Arm Type
Experimental
Arm Description
Endoscopic ultrasonography-guided double ethanol lavage
Intervention Type
Drug
Intervention Name(s)
Endoscopic ultrasonography-guided double ethanol lavage
Other Intervention Name(s)
Ethanol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Subjects with Complete or Partial response of treatment
Description
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)
Time Frame
1 year after final treatment
Secondary Outcome Measure Information:
Title
Incidence rate of adverse events after treatment
Description
Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability
Time Frame
1 year after final treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong-Kyun Lee, M.D., Ph.D.
Phone
82-2-3410-3407
Email
jongk.lee@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Kyun Lee, M.D., Ph.D.
Organizational Affiliation
Division of Gastroenterology, Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Cencer
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-Kyun Lee, M.D., Ph.D.
Phone
81-2-3410-3409
Email
jongk.lee@samsung.com
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Ultrasonography-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study
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