Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy
Primary Purpose
Pancreatic Pseudocysts
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic cyst-gastrostomy
Surgical cyst-gastrostomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Pseudocysts
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
Sites / Locations
- University of Alabama at birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Endoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy
Surgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic
Outcomes
Primary Outcome Measures
Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy
Secondary Outcome Measures
Quality of Life following treatment which will be assessed on a 3-month basis for 24-months using the SF-36 questionnaire
Median time to pseudocyst recurrence at 24 month follow-up.
Median time to pseudocyst recurrence at 24 month follow-up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00826501
Brief Title
Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy
Official Title
Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shyam Varadarajulu
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Pseudocysts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Endoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Surgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic
Intervention Type
Procedure
Intervention Name(s)
Endoscopic cyst-gastrostomy
Intervention Description
After passing a small camera into the stomach the pseudocyst will be punctured and drained into the stomach by stent placement.
Intervention Type
Procedure
Intervention Name(s)
Surgical cyst-gastrostomy
Intervention Description
After making an incision in the abdomen the pseudocyst contents will be emptied and the pseudocyst will be sutured to the stomach.
Primary Outcome Measure Information:
Title
Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Quality of Life following treatment which will be assessed on a 3-month basis for 24-months using the SF-36 questionnaire
Time Frame
24 months
Title
Median time to pseudocyst recurrence at 24 month follow-up.
Description
Median time to pseudocyst recurrence at 24 month follow-up.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Compare pain medication usage
Description
We will attempt to assess the amount of oral/transdermal opiate pain medication used in both arms to determine the efficacy of the neurolytic block.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama at birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23732774
Citation
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.
Results Reference
derived
Learn more about this trial
Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy
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