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

Sponsored by:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00826501

Purpose

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
Pancreatic Pseudocysts	Procedure: Endoscopic cyst-gastrostomy Procedure: Surgical cyst-gastrostomy

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

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

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

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
1: Active Comparator Endoscopic cyst-gastrostomy	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.
2: Active Comparator Surgical cyst-gastrostomy	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.

Eligibility

Ages Eligible for Study:	19 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826501

Locations

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

Sponsors and Collaborators

University of Alabama at Birmingham

More Information

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
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Digestive System Diseases
Pancreatic Cyst
Pancreatic Diseases
Pancreatic Pseudocyst
Cysts

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 30, 2009