PainNCT00968175
Endoscopic Ultrasound (EUS) Guided-Celiac Plexus Neurolysis (CPN) in Unresectable Pancreatic Cancer
A study testing Ultrasound guided celiac plexus neurolysis (CPN) in people with Pain and Pancreatic Cancer, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to decreasing the severity of abdominal pain when compared to analgesic therapy alone. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain, Pancreatic Cancer
- What is being tested?
- Ultrasound guided celiac plexus neurolysis (CPN)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- Age ≥19 yrs old
- Abdominal pain typical for pancreatic cancer ≥3/10
- Abdominal CT radiologically consistent with the diagnosis of pancreatic cancer
- Pancreatic cancer confirmed by FNA during EUS
- Inoperability of pancreatic cancer as determined during EUS or prior CT
Who cannot join
- Age < 19 yrs old
- Unable to safely undergo EUS for any reason
- Coagulopathy (prolongation of prothrombin time > 18 sec, thrombocytopenia <80,000 platelets/ml)
- Previous CPN or other neurolytic block that could affect pancreatic cancer -related pain or had implanted epidural or intrathecal analgesic therapy
- Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
- Potential patient noncompliance (refusing to follow schedule of events)
Show all 10Show fewer
- Active alcohol or other drug use or significant psychiatric illness
- Pregnant or breastfeeding
- Unable to consent
- Non-English speaking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Florida Hospital
Orlando, Florida, 32803
About this study
Official title: EUS Guided-Celiac Plexus Neurolysis (CPN) for Patients With Unresectable Pancreatic Cancer: A Multi-Center, Randomized, Single-Blinded Controlled Trial
The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to decreasing the severity of abdominal pain when compared to analgesic therapy alone.
Read the detailed description
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.
The secondary aims of this study are to evaluate the efficacy of EUS-CPN + analgesic therapy in improvement of quality of life (QOL) of patients with unresectable pancreatic cancer when compared to when compared with analgesic therapy alone, compare pain medication usage between Group 1 when compared to Group 2, and compare the referral for rescue block during the course of the study between Group 1 and Group 2
- Conditions
- Pain, Pancreatic Cancer
- Being tested
- Ultrasound guided celiac plexus neurolysis (CPN)
- Keywords
- Ultrasound guided celiac plexus neurolysis, CPN, Pancreatic Cancer, Pain Management
- Medical subject headings
- Pain, Pancreatic Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided celiac plexus neurolysis (CPN)Procedure or surgery
Also called EUS-CPN
Initial procedure and rescue procedure if applicable
| Study group | Role | What they receive |
|---|---|---|
| Group 1: CPN + analgesic therapy | Active comparator | Receives ultrasound guided celiac plexus neurolysis (CPN) in addition to standard analgesic therapy Receives: Procedure: Ultrasound guided celiac plexus neurolysis (CPN) |
| Analgesic therapy alone | No intervention | Will not receive ultrasound guided celiac plexus neurolysis (CPN); only standard analgesic therapy for pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy
Measured: ~ 2 year
Secondary outcomes (1)
To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL)
Measured: ~2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- AdventHealth
- Responsible party
- Sponsor
- Investigators
- Jayapal Ramesh, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968175
- Sponsor's protocol ID
- F090528002
- Status last verified
- May 2014
- First submitted
- 26 Aug 2009
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS Guided-Celiac Plexus Neurolysis (CPN) for Patients With Unresectable Pancreatic Cancer: A Multi-Center, Randomized, Single-Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT00968175
- Acronym / sponsor ID
- F090528002
- Conditions
- Pain, Pancreatic Cancer
- Keywords
- Ultrasound guided celiac plexus neurolysis, CPN, Pancreatic Cancer, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- AdventHealth
- Study start
- Jun 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Aug 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.
The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to decreasing the severity of abdominal pain when compared to analgesic therapy alone.
Detailed description
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.
The secondary aims of this study are to evaluate the efficacy of EUS-CPN + analgesic therapy in improvement of quality of life (QOL) of patients with unresectable pancreatic cancer when compared to when compared with analgesic therapy alone, compare pain medication usage between Group 1 when compared to Group 2, and compare the referral for rescue block during the course of the study between Group 1 and Group 2
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: CPN + analgesic therapy | Active comparator | Procedure: Ultrasound guided celiac plexus neurolysis (CPN)Receives ultrasound guided celiac plexus neurolysis (CPN) in addition to standard analgesic therapy |
| Analgesic therapy alone | No intervention | –Will not receive ultrasound guided celiac plexus neurolysis (CPN); only standard analgesic therapy for pain management |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female
- Age ≥19 yrs old
- Abdominal pain typical for pancreatic cancer ≥3/10
- Abdominal CT radiologically consistent with the diagnosis of pancreatic cancer
- Pancreatic cancer confirmed by FNA during EUS
Key exclusion criteria (10 listed)
- Age < 19 yrs old
- Unable to safely undergo EUS for any reason
- Coagulopathy (prolongation of prothrombin time > 18 sec, thrombocytopenia <80,000 platelets/ml)
- Previous CPN or other neurolytic block that could affect pancreatic cancer -related pain or had implanted epidural or intrathecal analgesic therapy
- Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
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 |
|---|---|---|
| Ultrasound guided celiac plexus neurolysis (CPN)Also: EUS-CPNInitial procedure and rescue procedure if applicable | Procedure or surgery | Group 1: CPN + analgesic therapy |
Primary outcome
The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy
Time frame: ~ 2 year
1 secondary outcome
To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL)
Time frame: ~2 year
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 4 Jun 2014.
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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.
Jayapal Ramesh, MD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided celiac plexus neurolysis (CPN) in people with Pain and Pancreatic Cancer, run by University of Alabama at Birmingham at 2 sites 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 6 inclusion and 10 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 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy (time frame: ~ 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2014.