Endoscopic Ultrasonography-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study
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|ClinicalTrials.gov Identifier: NCT02213419|
Recruitment Status : Unknown
Verified July 2014 by Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : August 11, 2014
Last Update Posted : February 12, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Mucinous-Cystic Neoplasm||Drug: Endoscopic ultrasonography-guided double ethanol lavage||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EUS-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
Experimental: ethanol double lavage
Endoscopic ultrasonography-guided double ethanol lavage
Drug: Endoscopic ultrasonography-guided double ethanol lavage
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.
Other Name: Ethanol
- Rate of Subjects with Complete or Partial response of treatment [ Time Frame: 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)
- Incidence rate of adverse events after treatment [ Time Frame: 1 year after final treatment ]Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213419
|Contact: Jong-Kyun Lee, M.D., Ph.D.||firstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Cencer||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Jong-Kyun Lee, M.D., Ph.D. 81-2-3410-3409 email@example.com|
|Principal Investigator:||Jong-Kyun Lee, M.D., Ph.D.||Division of Gastroenterology, Samsung Medical Center|