Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

Not Applicable

Completed

• Conditions: Pancreatic Pseudocysts
• Interventions: Procedure: Endoscopic cyst-gastrostomy; Procedure: Surgical cyst-gastrostomy

• Registration Number: NCT00826501
• Lead Sponsor: Shyam Varadarajulu

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-22
• Primary Completion: 2009-12
• Study Completion: 2012-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-15
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Endoscopic cyst-gastrostomy	Endoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy
2	Surgical cyst-gastrostomy	Surgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic

Primary Outcome Measures

Name	Time	Method
Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy	24 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life following treatment which will be assessed on a 3-month basis for 24-months using the SF-36 questionnaire	24 months
Median time to pseudocyst recurrence at 24 month follow-up.	24 months	Median time to pseudocyst recurrence at 24 month follow-up.

Trial Locations

Locations (1)

University of Alabama at birmingham; 🇺🇸 Birmingham, Alabama, United States