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2009-01
2009-12
2012-01
40
NCT00826501
University of Alabama at Birmingham
University of Alabama at Birmingham
INTERVENTIONAL
Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2009-01-20 | N/A | 2013-03-15 |
2009-01-20 | N/A | 2013-03-18 |
2009-01-22 | N/A | 2013-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: 1 Endoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy | PROCEDURE: Endoscopic cyst-gastrostomy
|
| ACTIVE_COMPARATOR: 2 Surgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic | PROCEDURE: Surgical cyst-gastrostomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy | 24 months |
| Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
