Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy

Conditions
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Pancreatic Pseudocysts

Intervention / Treatment
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* Procedure: Endoscopic cyst-gastrostomy
* Procedure: Surgical cyst-gastrostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 19yrs able to provide informed consent pancreatic pseudocyst by CT Exclusion Criteria: age < 19yrs unable to consent pancreatic abscess or necrosis

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Endoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy | Procedure: Endoscopic cyst-gastrostomy<br>* After passing a small camera into the stomach the pseudocyst will be punctured and drained into the stomach by stent placement.<br>|
| Active Comparator: 2<br>Surgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic | Procedure: Surgical cyst-gastrostomy<br>* After making an incision in the abdomen the pseudocyst contents will be emptied and the pseudocyst will be sutured to the stomach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Median time to pseudocyst recurrence at 24 month follow-up. | 24 months |