Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

Pancreatic Pseudocysts Clinical Trial

Official title:

Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826501
• Other study ID #: F080108003
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: March 15, 2013
• Start date: January 2009
• Est. completion date: January 2012

Study information

• Verified date: March 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 85 Years

Eligibility

Inclusion Criteria:

• age > 19yrs

• able to provide informed consent

• pancreatic pseudocyst by CT

Exclusion Criteria:

• age < 19yrs

• unable to consent

• pancreatic abscess or necrosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cyst
• Pancreatic Pseudocyst
• Pancreatic Pseudocysts

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Shyam Varadarajulu

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare pain medication usage	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.	24 months	No
Primary	Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy		24 months	Yes
Secondary	Quality of Life following treatment which will be assessed on a 3-month basis for 24-months using the SF-36 questionnaire		24 months	No
Secondary	Median time to pseudocyst recurrence at 24 month follow-up.	Median time to pseudocyst recurrence at 24 month follow-up.	24 months	No