Chronic PancreatitisPhase 4NCT00583479
Prospective Study of Celiac Block Injection: 1 vs. 2
A Phase 4 study testing one injection into the celiac ganglion and two injections into the celiac ganglion in people with Chronic Pancreatitis and Pancreatic Cancer, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this prospective randomized study is to compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis, Pancreatic Cancer
- What is being tested?
- one injection into the celiac ganglion and two injections into the celiac ganglion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Jul 2008
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block will be eligible to participate in this study. Chronic pancreatitis and pancreatic cancer must be measured and documented by prior CT, ERCP, or EUS.
- Patients should not have significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit survivability of the sedation given or the procedure.
- Age > or = to 18 years
- No evidence of significant active infection (ie. pneumonia, peritonitis, wound sepsis, etc)
- No evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc)
- No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
- Patient must provide signed written informed consent.
- Patients that have had a previous celiac plexus block are eligible for this study
Who cannot join
- The patient's celiac trunk should be imaged clearly under endoscopic ultrasound. The patient's celiac plexus should be accessed easily with a needle for the medication injection. If this cannot be done safely due to the patient's anatomy (intervening blood vessel or tumor), the patient will not be eligible for the procedure or study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clarian Health: Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: A Prospective Study of Celiac Block Technique: One Injection or Two?
The purpose of this prospective randomized study is to compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region.
- Conditions
- Chronic Pancreatitis, Pancreatic Cancer
- Being tested
- one injection into the celiac ganglion, two injections into the celiac ganglion
- Medical subject headings
- Pancreatitis, Chronic, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one injection into the celiac ganglionOther
one injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer
two injections into the celiac ganglionOther
two injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer
| Study group | Role | What they receive |
|---|---|---|
| A | Other | subjects who get one medication injection into the celiac ganglion during the EUS Receives: Other: one injection into the celiac ganglion |
| B | Other | subjects who get divided dose of the medication injected into two locations within the celiac ganglion during the EUS Receives: Other: two injections into the celiac ganglion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region
Measured: 24-hour after the procedure; then every week thereafter until the subject is no longer in the study
Secondary outcomes (3)
change in medication use
Measured: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
change is pain score
Measured: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
complications related to CB
Measured: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startJun 2002
- Primary completionJul 2008
- Study completionJul 2008
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 Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Investigators
- Julia LeBlanc, MD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583479
- Sponsor's protocol ID
- 0203-32
- Status last verified
- Sep 2012
- First submitted
- 20 Dec 2007
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
LeBlanc JK, Al-Haddad M, McHenry L, Sherman S, Juan M, McGreevy K, Johnson C, Howard TJ, Lillemoe KD, DeWitt J. A prospective, randomized study of EUS-guided celiac plexus neurolysis for pancreatic cancer: one injection or two? Gastrointest Endosc. 2011 Dec;74(6):1300-7. doi: 10.1016/j.gie.2011.07.073. Epub 2011 Oct 13.
PubMed 22000795
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Celiac Block Technique: One Injection or Two?
- ClinicalTrials.gov ID
- NCT00583479
- Acronym / sponsor ID
- 0203-32
- Conditions
- Chronic Pancreatitis, Pancreatic Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 31 Dec 2007 (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 prospective randomized study is to compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Other: one injection into the celiac ganglionsubjects who get one medication injection into the celiac ganglion during the EUS |
| B | Other | Other: two injections into the celiac ganglionsubjects who get divided dose of the medication injected into two locations within the celiac ganglion during the EUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block will be eligible to participate in this study. Chronic pancreatitis and pancreatic cancer must be measured and documented by prior CT, ERCP, or EUS.
- Patients should not have significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit survivability of the sedation given or the procedure.
- Age > or = to 18 years
- No evidence of significant active infection (ie. pneumonia, peritonitis, wound sepsis, etc)
- No evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc)
Key exclusion criteria (1 listed)
- The patient's celiac trunk should be imaged clearly under endoscopic ultrasound. The patient's celiac plexus should be accessed easily with a needle for the medication injection. If this cannot be done safely due to the patient's anatomy (intervening blood vessel or tumor), the patient will not be eligible for the procedure or study.
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 |
|---|---|---|
| one injection into the celiac ganglionone injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer | Other | A |
| two injections into the celiac gangliontwo injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer | Other | B |
Primary outcome
Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region
Time frame: 24-hour after the procedure; then every week thereafter until the subject is no longer in the study
3 secondary outcomes
change in medication use
Time frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
change is pain score
Time frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
complications related to CB
Time frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
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 12 Sep 2012.
- Derived from this study: PubMed 22000795LeBlanc JK, Al-Haddad M, McHenry L, Sherman S, Juan M, McGreevy K, Johnson C, Howard TJ, Lillemoe KD, DeWitt J. A prospective, randomized study of EUS-guided celiac plexus neurolysis for pancreatic cancer: one injection or two? Gastrointest Endosc. 2011 Dec;74(6):1300-7. doi: 10.1016/j.gie.2011.07.073. Epub 2011 Oct 13.
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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.
Julia LeBlanc, MD, MPH principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing one injection into the celiac ganglion and two injections into the celiac ganglion in people with Chronic Pancreatitis and Pancreatic Cancer, run by Indiana University 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 8 inclusion and 1 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 12 Sep 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region (time frame: 24-hour after the procedure; then every week thereafter until the subject is no longer in the study). 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 NCT00583479, 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 12 Sep 2012.