Chronic PancreatitisNCT02054910
CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
A study testing Celiac Plexus Block in people with Chronic Pancreatitis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Celiac Plexus Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All patients referred to UAB Endoscopy Unit for with known chronic pancreatitis
- Patients referred to the endoscopy unit with abdominal pain with suspicion of chronic pancreatitis meeting 5 of 9 parenchymal and ductal changes (i.e. lobulations, hyperechoic stranding, hyperechoic foci, cysts, calcification, irregular duct, hyperechoic walls, side branch dilations and ductal calculi).
Who cannot join
- Age <19 years
- Unable to safely undergo EUS for any reason
- Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
- Unable to consent
- Non-English speaking patients.
- Previously undergone CPB
Show all 11Show fewer
- Pregnancy and Breast feeding
- Patients with ductal strictures, calcification, pancreatic ductal calculi, pseudocysts.
- Previous pancreatic surgery
- Previous pseudocyst drainage
- Other documented causes of abdominal pain.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Randomized Single Blinded Control Trial Comparing EUS Guided Celiac Plexus Block (CPB) Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed.
Read the detailed description
The purpose of this study is to assess pain response to EUS guided celiac plexus block treatment compared to no treatment. The Visual Analog Scale (VAS) is the primary measure. Secondary aims include the comparison of quality of life scores, need for narcotics, to assess the effect of EUS-CPB on overall mental state using the Beck's Depression Index, and to assess the effect of EUS-CBP on health care utilization and on employment.
- Conditions
- Chronic Pancreatitis
- Being tested
- Celiac Plexus Block, Sham
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celiac Plexus BlockProcedure or surgery
Patients will receive celiac plexus block during endoscopy.
ShamProcedure or surgery
Patients will not receive celiac plexus block during endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Celiac Plexus Block | Experimental | Celiac Plexus Block will be administered following EUS Receives: Procedure: Celiac Plexus Block |
| Sham | Sham comparator | A celiac plexus block will not be administered for pain management Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Response Over a 6 Month Period of Time Using the VAS Score
Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain.
Measured: baseline to 6 months
Secondary outcomes (5)
Mean Quality of Life Score Between Each Group at 6 Months
The American Chronic Pain Association, Quality of Life Score will be used. This scoring ranges from 0 (Stay in bed all day Feel hopeless and helpless about life - non-functioning) to 10 (Go to work/volunteer each day Normal daily activities each day Have a social life outside of work Take an active part in family life - normal life).
Measured: 6 months post baseline
Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline
the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.
Measured: baseline to 6 months
Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.
The Beck's Depression scale was used to indicate subject's depression:
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
Measured: baseline to 6 months
Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure
The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group
Measured: baseline to 6 months
% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.
Subjects will be asked about employment at 6 months post procedure
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PancreatitisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Mel Wilcox, MD, University of Alabama at Birmingham
- Investigators
- Charles M Wilcox, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054910
- Sponsor's protocol ID
- F130822012
- Status last verified
- Jan 2017
- First submitted
- 29 Jan 2014
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Single Blinded Control Trial Comparing EUS Guided Celiac Plexus Block (CPB) Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT02054910
- Acronym / sponsor ID
- F130822012
- Conditions
- Chronic Pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Posted 28 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed.
Detailed description
The purpose of this study is to assess pain response to EUS guided celiac plexus block treatment compared to no treatment. The Visual Analog Scale (VAS) is the primary measure. Secondary aims include the comparison of quality of life scores, need for narcotics, to assess the effect of EUS-CPB on overall mental state using the Beck's Depression Index, and to assess the effect of EUS-CBP on health care utilization and on employment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celiac Plexus Block | Experimental | Procedure: Celiac Plexus BlockCeliac Plexus Block will be administered following EUS |
| Sham | Sham comparator | Procedure: ShamA celiac plexus block will not be administered 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 (2 listed)
- All patients referred to UAB Endoscopy Unit for with known chronic pancreatitis
- Patients referred to the endoscopy unit with abdominal pain with suspicion of chronic pancreatitis meeting 5 of 9 parenchymal and ductal changes (i.e. lobulations, hyperechoic stranding, hyperechoic foci, cysts, calcification, irregular duct, hyperechoic walls, side branch dilations and ductal calculi).
Key exclusion criteria (11 listed)
- Age <19 years
- Unable to safely undergo EUS for any reason
- Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
- Unable to consent
- Non-English speaking patients.
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 |
|---|---|---|
| Celiac Plexus BlockPatients will receive celiac plexus block during endoscopy. | Procedure or surgery | Celiac Plexus Block |
| ShamPatients will not receive celiac plexus block during endoscopy. | Procedure or surgery | Sham |
Primary outcome
Change in Pain Response Over a 6 Month Period of Time Using the VAS Score
Time frame: baseline to 6 months
Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain.
5 secondary outcomes
Mean Quality of Life Score Between Each Group at 6 Months
Time frame: 6 months post baseline
Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline
Time frame: baseline to 6 months
Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.
Time frame: baseline to 6 months
Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure
Time frame: baseline to 6 months
% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.
Time frame: baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
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.
Charles M Wilcox, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celiac Plexus Block in people with Chronic Pancreatitis, run by University of Alabama at Birmingham 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 2 inclusion and 11 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 28 Feb 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Pain Response Over a 6 Month Period of Time Using the VAS Score (time frame: baseline to 6 months). 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 28 Feb 2017.