Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

Shyam Varadarajulu

Status: Completed

Conditions: Pancreatic Pseudocysts

Treatments: Procedure: Surgical cyst-gastrostomy; Procedure: Endoscopic cyst-gastrostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00826501

F080108003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• age < 19yrs
• unable to consent
• pancreatic abscess or necrosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Active Comparator group

Description:

Endoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy

Treatment:

Procedure: Endoscopic cyst-gastrostomy

2

Active Comparator group

Description:

Surgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic

Treatment:

Procedure: Surgical cyst-gastrostomy