Pancreatic Pseudocysts
Conditions
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.
Interventions
PROCEDUREEndoscopic cyst-gastrostomy
After passing a small camera into the stomach the pseudocyst will be punctured and drained into the stomach by stent placement.
PROCEDURESurgical cyst-gastrostomy
After making an incision in the abdomen the pseudocyst contents will be emptied and the pseudocyst will be sutured to the stomach.
Sponsors
Shyam Varadarajulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* age \> 19yrs * able to provide informed consent * pancreatic pseudocyst by CT
Exclusion criteria
* age \< 19yrs * unable to consent * pancreatic abscess or necrosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compare pain medication usage | 24 months | 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. |
Countries
United States
Outcome results
None listed