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Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

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ClinicalTrials.gov Identifier: NCT00826501
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : March 18, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Pancreatic Pseudocysts Procedure: Endoscopic cyst-gastrostomy Procedure: Surgical cyst-gastrostomy

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy
Study Start Date : January 2009
Primary Completion Date : December 2009
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Endoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy
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.
Active Comparator: 2
Surgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic
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.


Outcome Measures

Primary Outcome Measures :
  1. Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Median time to pseudocyst recurrence at 24 month follow-up. [ Time Frame: 24 months ]
    Median time to pseudocyst recurrence at 24 month follow-up.


Other Outcome Measures:
  1. Compare pain medication usage [ Time Frame: 24 months ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826501


Locations
United States, Alabama
University of Alabama at birmingham
Birmingham, Alabama, United States, 35244
Sponsors and Collaborators
Shyam Varadarajulu
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shyam Varadarajulu, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00826501     History of Changes
Other Study ID Numbers: F080108003
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Pancreatic Cyst
Pancreatic Pseudocyst
Cysts
Neoplasms
Pancreatic Diseases
Digestive System Diseases