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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
Shyam Varadarajulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Pseudocysts

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 20, 2009
Last Updated
March 15, 2013
Sponsor
Shyam Varadarajulu
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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

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Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

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