Clinical trial NCT02213419: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pancreatic Mucinous-Cystic Neoplasm
Keywords: Cystic Tumors of the Pancreas
Endoscopic Ultrasound
Ethanol
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Rate of Subjects with Complete or Partial response of treatment
timeFrame: 1 year after final treatment
Secondary outcomes:
measure: Incidence rate of adverse events after treatment
timeFrame: 1 year after final treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Cencer
Study officials:
affiliation: Division of Gastroenterology, Samsung Medical Center
name: Jong-Kyun Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: