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Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy


N/A
19 Years
85 Years
Not Enrolling
Both
Pancreatic Pseudocysts

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Trial Information

Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy


The purpose of this study is to examine endoscopic ultrasound guided celiac plexus
neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer will
decrease the severity of abdominal pain when compared to analgesic therapy alone. The
specific primary aim of this study is to evaluate the efficacy of EUS-CPN + analgesic
therapy (Group 1) in pain relief of patients with unresectable pancreatic cancer when
compared with analgesic therapy (Group 2). The hypothesis will be tested by comparing the
changes in reported pain severity between those who receive EUS-CPN in addition to analgesic
therapy as compared to analgesic therapy alone.


Inclusion Criteria:



- age > 19yrs

- able to provide informed consent

- pancreatic pseudocyst by CT

Exclusion Criteria:

- age < 19yrs

- unable to consent

- pancreatic abscess or necrosis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy

Outcome Time Frame:

24 months

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

F080108003

NCT ID:

NCT00826501

Start Date:

January 2009

Completion Date:

January 2012

Related Keywords:

  • Pancreatic Pseudocysts
  • Pancreatic Cyst
  • Pancreatic Pseudocyst

Name

Location

University of Alabama at Birmingham Birmingham, Alabama  35294-3300