Pancreatic Mucinous-Cystic Neoplasm Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | August 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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). |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Samsung Medical Cencer | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 | Yes |
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