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

Phase 1

• Conditions: Pancreatic Mucinous-Cystic Neoplasm
• Interventions: Drug: Endoscopic ultrasonography-guided double ethanol lavage

• Registration Number: NCT02213419
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-11
• Study Start: 2014-10
• Last Update Submitted: 2015-02-10
• Last Update Posted: 2015-02-12
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ethanol double lavage	Endoscopic ultrasonography-guided double ethanol lavage	Endoscopic ultrasonography-guided double ethanol lavage

Primary Outcome Measures

Name	Time	Method
Rate of Subjects with Complete or Partial response of treatment	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Cencer; 🇰🇷 Seoul, Korea, Republic of