Chronic PancreatitisNCT00583271
A Prospective Study of EUS Guided Celiac Block
An observational study of Chronic Pancreatitis and Pancreatic Cancer, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons. 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?
- triamcinolone and 98% dehydrated alcohol
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Dec 2012
- Phase
- Observational
- 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
Study population: Patients with abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block.
Who may be able to join
- Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer or other visceral malignancy that are undergoing EUS-guided CB (for purposes other than this study) will be eligible to participate in this study.
- Patients with chronic pancreatitis and pancreatic cancer must have documented disease by CT, ERCP, or EUS.
- 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
Who cannot join
- Patients that have had a previous celiac plexus block are eligible for this 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 Endoscopic Ultrasound-guided Celiac (CB) Effectiveness
The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons.
- Conditions
- Chronic Pancreatitis, Pancreatic Cancer
- Being tested
- triamcinolone, 98% dehydrated alcohol
- 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.
triamcinoloneDrug
Also called Kenalog 80mg
80mg of triamcinolone injected into the celiac ganglion during the EUS-CB
98% dehydrated alcoholDrug
10ml of 98% dehydrated alcohol injected into the celiac ganglion during the EUS-CB
| Study group | Role | What they receive |
|---|---|---|
| 1 | subjects who are getting a celiac block for chronic pancreatitis Receives: Drug: triamcinolone | |
| 2 | subjects who are getting a celiac block for pancreatic cancer Receives: Drug: 98% dehydrated alcohol |
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 completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia LeBlanc, MD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583271
- Sponsor's protocol ID
- 0205-04B
- Other IDs
- IRB #0205-04B
- Status last verified
- Sep 2014
- First submitted
- 20 Dec 2007
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Endoscopic Ultrasound-guided Celiac (CB) Effectiveness
- ClinicalTrials.gov ID
- NCT00583271
- Acronym / sponsor ID
- 0205-04B
- Conditions
- Chronic Pancreatitis, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (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 study is to measure the clinical effectiveness of EUS-guided CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: triamcinolonesubjects who are getting a celiac block for chronic pancreatitis |
| 2 | – | Drug: 98% dehydrated alcoholsubjects who are getting a celiac block for pancreatic cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block.
Key inclusion criteria (4 listed)
- Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer or other visceral malignancy that are undergoing EUS-guided CB (for purposes other than this study) will be eligible to participate in this study.
- Patients with chronic pancreatitis and pancreatic cancer must have documented disease by CT, ERCP, or EUS.
- 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
Key exclusion criteria (1 listed)
- Patients that have had a previous celiac plexus block are eligible for this 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 |
|---|---|---|
| triamcinoloneAlso: Kenalog 80mg80mg of triamcinolone injected into the celiac ganglion during the EUS-CB | Drug | 1 |
| 98% dehydrated alcohol10ml of 98% dehydrated alcohol injected into the celiac ganglion during the EUS-CB | Drug | 2 |
Primary outcome
Not reported in the source record.
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 5 Sep 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.
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?
An observational study of 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 4 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 5 Sep 2014. 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.
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 5 Sep 2014.