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Sponsored by: |
University of Alabama at Birmingham |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00826501 |
Patients with pancreatitis can develop inflammatory fluid collection around the pancreas called pseudocysts. Pseudocysts may cause abdominal pain when they are more than 6cm in size. These pseudocysts can be treated (drained) by surgery or by endoscopy. Both treatment options are the current standard-of-care at all institutions around the World. The aim of this study is to identify the better of the two techniques, surgery versus endoscopy, for treatment of patients with pancreatic pseudocysts. This will be done by comparing a) the treatment success rates b) quality of life of patients following treatment and c) cost associated with treatment, between both treatment modalities.
Condition | Intervention |
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Pancreatic Pseudocysts |
Procedure: Endoscopic cyst-gastrostomy Procedure: Surgical cyst-gastrostomy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-Gastrostomy |
Estimated Enrollment: | 30 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Endoscopic cyst-gastrostomy
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Procedure: Endoscopic cyst-gastrostomy
After passing a small camera into the stomach the pseudocyst will be punctured and drained into the stomach by stent placement.
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2: Active Comparator
Surgical cyst-gastrostomy
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Procedure: Surgical cyst-gastrostomy
After making an incision in the abdomen the pseudocyst contents will be emptied and the pseudocyst will be sutured to the stomach.
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Ages Eligible for Study: | 19 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at birmingham | Recruiting |
Birmingham, Alabama, United States, 35244 | |
Contact: Shyam Varadarajulu, MD 205-934-7989 svaradarajulu@uab.edu | |
Contact: John D Christein, MD 934-9086 jdc16@uab.edu | |
Principal Investigator: Shyam Varadarajulu, MD |
Responsible Party: | University of Alabama at Birmingham ( Shyam Varadarajulu ) |
Study ID Numbers: | F080108003 |
Study First Received: | January 20, 2009 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00826501 History of Changes |
Health Authority: | United States: Institutional Review Board |
Digestive System Diseases Pancreatic Cyst Pancreatic Diseases Pancreatic Pseudocyst Cysts |
Neoplasms Digestive System Diseases Pancreatic Cyst |
Pancreatic Diseases Pancreatic Pseudocyst Cysts |