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

Samsung Medical Center

Status and phase

Unknown

Phase 1

Conditions

Pancreatic Mucinous-Cystic Neoplasm

Treatments

Drug: Endoscopic ultrasonography-guided double ethanol lavage

Study type

Interventional

Funder types

Other

Identifiers

NCT02213419

2014-06-058-001

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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).