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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ethanol double lavage | Experimental | Endoscopic ultrasonography-guided double ethanol lavage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasonography-guided double ethanol lavage | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong-Kyun Lee, M.D., Ph.D. | Contact | 82-2-3410-3407 | jongk.lee@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Jong-Kyun Lee, M.D., Ph.D. | Division of Gastroenterology, Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Cencer | Recruiting | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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