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Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shyam Varadarajulu, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00826501
First received: January 20, 2009
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  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 rates of pseudocyst recurrence 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

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

Primary Outcome Measures:
  • Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Median time to pseudocyst recurrence at 24 month follow-up. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Median time to pseudocyst recurrence at 24 month follow-up.


Other Outcome Measures:
  • Compare pain medication usage [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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
Birmingham, Alabama, United States, 35244
Sponsors and Collaborators
Shyam Varadarajulu
  More Information

No publications provided

Responsible Party: Shyam Varadarajulu, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00826501     History of Changes
Other Study ID Numbers: F080108003
Study First Received: January 20, 2009
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013