Pancreatic PseudocystsNCT00826501
Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy
A study testing Endoscopic cyst-gastrostomy and Surgical cyst-gastrostomy in people with Pancreatic Pseudocysts, run by Shyam Varadarajulu at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Pancreatic Pseudocysts
- What is being tested?
- Endoscopic cyst-gastrostomy and Surgical cyst-gastrostomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 19yrs
- able to provide informed consent
- pancreatic pseudocyst by CT
Who cannot join
- age < 19yrs
- unable to consent
- pancreatic abscess or necrosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at birmingham
Birmingham, Alabama, 35244
About this study
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.
Read the 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
- Being tested
- Endoscopic cyst-gastrostomy, Surgical cyst-gastrostomy
- Medical subject headings
- Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic cyst-gastrostomyProcedure or surgery
After passing a small camera into the stomach the pseudocyst will be punctured and drained into the stomach by stent placement.
Surgical cyst-gastrostomyProcedure or surgery
After making an incision in the abdomen the pseudocyst contents will be emptied and the pseudocyst will be sutured to the stomach.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Endoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy Receives: Procedure: Endoscopic cyst-gastrostomy |
| 2 | Active comparator | Surgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic Receives: Procedure: Surgical cyst-gastrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy
Measured: 24 months
Secondary outcomes (2)
Quality of Life following treatment which will be assessed on a 3-month basis for 24-months using the SF-36 questionnaire
Measured: 24 months
Median time to pseudocyst recurrence at 24 month follow-up.
Median time to pseudocyst recurrence at 24 month follow-up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic PseudocystsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shyam Varadarajulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shyam Varadarajulu, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826501
- Sponsor's protocol ID
- F080108003
- Status last verified
- Mar 2013
- First submitted
- 20 Jan 2009
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Varadarajulu S, Bang JY, Sutton BS, Trevino JM, Christein JD, Wilcox CM. Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial. Gastroenterology. 2013 Sep;145(3):583-90.e1. doi: 10.1053/j.gastro.2013.05.046. Epub 2013 May 31.
PubMed 23732774
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy
- ClinicalTrials.gov ID
- NCT00826501
- Acronym / sponsor ID
- F080108003
- Conditions
- Pancreatic Pseudocysts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shyam VaradarajuluUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Endoscopic cyst-gastrostomyEndoscopic cyst-gastrostomy with a neurolytic block along with oral/transdermal analgesic therapy |
| 2 | Active comparator | Procedure: Surgical cyst-gastrostomySurgical cyst-gastrostomy with neurolytic block and pain managed by only oral/transdermal analgesic |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 19yrs
- able to provide informed consent
- pancreatic pseudocyst by CT
Key exclusion criteria (3 listed)
- age < 19yrs
- unable to consent
- pancreatic abscess or necrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic cyst-gastrostomyAfter passing a small camera into the stomach the pseudocyst will be punctured and drained into the stomach by stent placement. | Procedure or surgery | 1 |
| Surgical cyst-gastrostomyAfter making an incision in the abdomen the pseudocyst contents will be emptied and the pseudocyst will be sutured to the stomach. | Procedure or surgery | 2 |
Primary outcome
Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy
Time frame: 24 months
2 secondary outcomes
Quality of Life following treatment which will be assessed on a 3-month basis for 24-months using the SF-36 questionnaire
Time frame: 24 months
Median time to pseudocyst recurrence at 24 month follow-up.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
- Derived from this study: PubMed 23732774Varadarajulu S, Bang JY, Sutton BS, Trevino JM, Christein JD, Wilcox CM. Equal efficacy of endoscopic and surgical cystogastrostomy for pancreatic pseudocyst drainage in a randomized trial. Gastroenterology. 2013 Sep;145(3):583-90.e1. doi: 10.1053/j.gastro.2013.05.046. Epub 2013 May 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic cyst-gastrostomy and Surgical cyst-gastrostomy in people with Pancreatic Pseudocysts, run by Shyam Varadarajulu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00826501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2013.