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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

January 20, 2009
March 15, 2013
January 2009
December 2009   (final data collection date for primary outcome measure)
Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Treatment success rate defined as ability to successfully drain the pseudocyst and patient being relieved of symptoms [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00826501 on ClinicalTrials.gov Archive Site
  • 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.
Quality of Life following treatment which will be assessed on a 3-month basis for 18-months using the SF-36 questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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.
Not Provided
 
Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy
Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Pseudocysts
  • 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.
  • 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.
  • Active Comparator: 1
    Endoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy
    Intervention: Procedure: Endoscopic cyst-gastrostomy
  • Active Comparator: 2
    Surgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic
    Intervention: Procedure: Surgical cyst-gastrostomy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2012
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age > 19yrs
  • able to provide informed consent
  • pancreatic pseudocyst by CT

Exclusion Criteria:

  • age < 19yrs
  • unable to consent
  • pancreatic abscess or necrosis
Both
19 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00826501
F080108003
No
Shyam Varadarajulu, University of Alabama at Birmingham
Shyam Varadarajulu
Not Provided
Not Provided
University of Alabama at Birmingham
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP