Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-Gastrostomy - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	January 20, 2009
Last Updated Date	January 20, 2009
Start Date ^†	February 2008
Current Primary Outcome Measures ^† (submitted: January 21, 2009)	Treatment success rate defined as ability to successfully drain the pseudocyst and patient being relieved of symptoms [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^†	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^† (submitted: January 21, 2009)	Quality of Life following treatment which will be assessed on a 3-month basis for 18-months using the SF-36 questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-Gastrostomy
Official Title ^†	Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-Gastrostomy
Brief Summary	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.
Detailed Description
Study Phase
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Pancreatic Pseudocysts
Intervention ^†	Procedure: Endoscopic cyst-gastrostomy Procedure: Surgical cyst-gastrostomy
Study Arms / Comparison Groups	Active Comparator: Endoscopic cyst-gastrostomy Active Comparator: Surgical cyst-gastrostomy
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Recruiting
Estimated Enrollment ^†	30
Estimated Completion Date	November 2009
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: age > 19yrs able to provide informed consent pancreatic pseudocyst by CT Exclusion Criteria: age < 19yrs unable to consent pancreatic abscess or necrosis
Gender	Both
Ages	19 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00826501
Responsible Party	Shyam Varadarajulu, University of Alabama at Birmingham
Secondary IDs ^††
Study Sponsor ^†	University of Alabama at Birmingham
Collaborators ^††
Investigators ^†
Information Provided By	University of Alabama at Birmingham
Verification Date	January 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.