A Phase 1 interventional study of Endoscopic ultrasonography-guided double ethanol lavage in Pancreatic Mucinous-Cystic Neoplasm, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-12.
Sponsored by Samsung Medical Center · Phase 1, Interventional, and Treatment
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.
94 studies on the registry are indexed under Pancreatic Cyst; 34 are open to participants now.
This study's planned enrollment of 40 is below the median of 67 across 40 interventional studies indexed under Pancreatic Cyst.
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Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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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.
Also known as: Ethanol
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)
Time frame: 1 year after final treatment
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
Time frame: 1 year after final treatment
This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center