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Phase 2/3 Study of EUS-guided Ethanol Lavage With Paclitaxel Injection for Cystic Tumors of the Pancreas


Phase 2/Phase 3
20 Years
85 Years
Open (Enrolling)
Both
Cystic Tumors of the Pancreas

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Trial Information

Phase 2/3 Study of EUS-guided Ethanol Lavage With Paclitaxel Injection for Cystic Tumors of the Pancreas


Inclusion Criteria:



- uni- or oligo-locular cystic tumors

- indeterminate cystic tumors for which EUS-guided fine needle aspiration (FNA) was
required to obtain additional information

- cystic tumors that increased in size during the observation period

Exclusion Criteria:

- cystic tumors which had the typical morphology of serous cystadenomas (i.e.,
honeycomb appearance) and pseudocysts (i.e., parenchymal changes)

- evidence of communication between the cystic lesion and the main pancreatic duct
according to endoscopic retrograde pancreatograms

- overt carcinomas with peripancreatic invasion

- patients with a bleeding tendency (prothrombin time > 1.5 international normalized
ratio [INR] or platelet count < 50,000/μL).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of complications Treatment response by change of calculated cyst volume

Outcome Time Frame:

30-days for complication and at least 6 months for treatment response

Safety Issue:

Yes

Principal Investigator

Dong Wan Seo, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center, University of Ulsan Collge of Medicine

Authority:

Korea: Food and Drug Administration

Study ID:

AMC0183

NCT ID:

NCT00689715

Start Date:

June 2006

Completion Date:

February 2012

Related Keywords:

  • Cystic Tumors of the Pancreas
  • Cystic tumor
  • Pancreas
  • EUS
  • Pancreatic Neoplasms

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