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Trial record 66 of 130 for:    Pancreatic Cancer | ( Map: South Korea )

Endoscopic Ultrasonography-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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.


Condition or disease Intervention/treatment Phase
Pancreatic Mucinous-Cystic Neoplasm Drug: Endoscopic ultrasonography-guided double ethanol lavage Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Ultrasound

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

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


Contacts
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Contact: Jong-Kyun Lee, M.D., Ph.D. 82-2-3410-3407 jongk.lee@samsung.com

Locations
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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    jongk.lee@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jong-Kyun Lee, M.D., Ph.D. Division of Gastroenterology, Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02213419     History of Changes
Other Study ID Numbers: 2014-06-058-001
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: July 2014
Keywords provided by Samsung Medical Center:
Cystic Tumors of the Pancreas
Endoscopic Ultrasound
Ethanol
Additional relevant MeSH terms:
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Pancreatic Cyst
Cysts
Neoplasms
Pancreatic Diseases
Digestive System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs