NCT00826501

Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Shyam Varadarajulu · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Pseudocysts

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-12-01
• Completion: 2012-01-01
• First posted: 2009-01-22
• Last updated: 2013-03-18

Locations

1 site across 1 country: United States