Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy
1 other identifier
interventional
40
1 country
1
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 rates of pseudocyst recurrence b) quality of life of patients following treatment and c) cost associated with treatment, between both treatment modalities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
January 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMarch 18, 2013
March 1, 2013
11 months
January 20, 2009
March 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy
24 months
Secondary Outcomes (2)
Quality of Life following treatment which will be assessed on a 3-month basis for 24-months using the SF-36 questionnaire
24 months
Median time to pseudocyst recurrence at 24 month follow-up.
24 months
Other Outcomes (1)
Compare pain medication usage
24 months
Study Arms (2)
1
ACTIVE COMPARATOREndoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy
2
ACTIVE COMPARATORSurgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic
Interventions
After passing a small camera into the stomach the pseudocyst will be punctured and drained into the stomach by stent placement.
After making an incision in the abdomen the pseudocyst contents will be emptied and the pseudocyst will be sutured to the stomach.
Eligibility Criteria
You may qualify if:
- age \> 19yrs
- able to provide informed consent
- pancreatic pseudocyst by CT
You may not qualify if:
- age \< 19yrs
- unable to consent
- pancreatic abscess or necrosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at birmingham
Birmingham, Alabama, 35244, United States
Related Publications (1)
Varadarajulu S, Bang JY, Sutton BS, Trevino JM, Christein JD, Wilcox CM. Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial. Gastroenterology. 2013 Sep;145(3):583-90.e1. doi: 10.1053/j.gastro.2013.05.046. Epub 2013 May 31.
PMID: 23732774DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 20, 2009
First Posted
January 22, 2009
Study Start
January 1, 2009
Primary Completion
December 1, 2009
Study Completion
January 1, 2012
Last Updated
March 18, 2013
Record last verified: 2013-03