Pancreatitis, ChronicNCT03070210
Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis
A study testing EUS-celiac ganglia block (EUS-CGB) and EUS-celiac plexus block (EUS-CPB) in people with Pancreatitis, Chronic and Abdominal Pain, run by The Cleveland Clinic at 1 site in United States.
Trial summary
AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided celiac ganglia block (EUS-CGB) vs standard endoscopic ultrasound-guided celiac plexus block (EUS-CPB). METHODS: This is a single-center, double-blind, randomized parallel-group study to assess the efficacy of EUS-CPB vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Chronic, Abdominal Pain
- What is being tested?
- EUS-celiac ganglia block (EUS-CGB) and EUS-celiac plexus block (EUS-CPB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2017to 1 Aug 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with chronic pancreatitis and referred for EUS-guided celiac plexus block with: age>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain.
Who cannot join
- pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (>1.5) or low platelet count (<75 cells/mm3), allergy to eggs or "caine" anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Blockade (EUS-CPB) With Standard Plexus Injection vs. Direct Celiac Ganglia Block for Treatment of Pain in Chronic Pancreatitis.
AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided celiac ganglia block (EUS-CGB) vs standard endoscopic ultrasound-guided celiac plexus block (EUS-CPB).
METHODS: This is a single-center, double-blind, randomized parallel-group study to assess the efficacy of EUS-CPB vs. EUS-CGB in patients with painful chronic pancreatitis.
Read the detailed description
Inclusion criteria include: age>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain.
Exclusion criteria include: pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (>1.5) or low platelet count (<75 cells/mm3), allergy to eggs or "caine" anesthetics.
- Conditions
- Pancreatitis, Chronic, Abdominal Pain
- Being tested
- EUS-celiac ganglia block (EUS-CGB), EUS-celiac plexus block (EUS-CPB)
- Medical subject headings
- Pancreatitis, Chronic, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-celiac ganglia block (EUS-CGB)Procedure or surgery
The intervention technique of EUS-CGB is the realization of EUS-guided celiac block with injection of bupivacaine directly into the ganglia for patients with chronic pancreatitis.
EUS-celiac plexus block (EUS-CPB)Procedure or surgery
In the arm of EUS-CPB, the procedure is going to be performed with the standard EUS-guided celiac plexus block with injection of bupivacaine into the retroperitoneal space.
| Study group | Role | What they receive |
|---|---|---|
| EUS-celiac plexus block (EUS-CPB) | Other | This is the standard technique. In this approach, the needle is passed through the body of the stomach adjacent the celiac artery into the retroperitoneal space in 1 or 2 passes. The injectate (bupivacaine or alcohol) is injected and spreads through the retroperitoneal space, effectively "bathing" all the ganglia. Receives: Procedure: EUS-celiac plexus block (EUS-CPB) |
| EUS-celiac ganglia block (EUS-CGB) | Active comparator | This is a more recent technique which has been often used. In this procedure, the needle is inserted under EUS guidance directly into as many ganglia as possible. For celiac ganglia <1cm in diameter, the solution is injected into the central point; for those ≥1 cm, a needle is advanced to the deepest point into the ganglia and solution is injected as the needle is slowly withdrawn. Injections are continued until an echogenic pattern is produced over the entire celiac ganglia. Receives: Procedure: EUS-celiac ganglia block (EUS-CGB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
The primary endpoint will be pain relief at 1 week after the block, defined as a decrease of 3 or more points in the VAS scale measuring "average pain over past week".
Measured: 1 week
Secondary outcomes (4)
Complete response rate
Decrease in pain to 1 or 0.
Measured: 1 week
Duration of pain relief
Duration of pain relief will be assessed during a 2-month follow-up.
Measured: up to 2 months
Opioid consumption
Assess the opioid consumption in up to 2 months after endoscopic therapy.
Measured: up to 2 months
Adverse effects
Assess the incidence of adverse effects after endoscopic therapy.
Measured: in up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start25 Jan 2017
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, ChronicStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler Stevens, The Cleveland Clinic
- Investigators
- Tyler Stevens, MD, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070210
- Sponsor's protocol ID
- 16-1543
- Status last verified
- Apr 2020
- First submitted
- 28 Feb 2017
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doi S, Yasuda I, Kawakami H, Hayashi T, Hisai H, Irisawa A, Mukai T, Katanuma A, Kubota K, Ohnishi T, Ryozawa S, Hara K, Itoi T, Hanada K, Yamao K. Endoscopic ultrasound-guided celiac ganglia neurolysis vs. celiac plexus neurolysis: a randomized multicenter trial. Endoscopy. 2013;45(5):362-9. doi: 10.1055/s-0032-1326225. Epub 2013 Apr 24.
PubMed 23616126Ascunce G, Ribeiro A, Reis I, Rocha-Lima C, Sleeman D, Merchan J, Levi J. EUS visualization and direct celiac ganglia neurolysis predicts better pain relief in patients with pancreatic malignancy (with video). Gastrointest Endosc. 2011 Feb;73(2):267-74. doi: 10.1016/j.gie.2010.10.029.
PubMed 21295640
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Blockade (EUS-CPB) With Standard Plexus Injection vs. Direct Celiac Ganglia Block for Treatment of Pain in Chronic Pancreatitis.
- ClinicalTrials.gov ID
- NCT03070210
- Acronym / sponsor ID
- 16-1543
- Conditions
- Pancreatitis, Chronic, Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 3 Mar 2017 (actual)
- 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.
AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided celiac ganglia block (EUS-CGB) vs standard endoscopic ultrasound-guided celiac plexus block (EUS-CPB).
METHODS: This is a single-center, double-blind, randomized parallel-group study to assess the efficacy of EUS-CPB vs. EUS-CGB in patients with painful chronic pancreatitis.
Detailed description
Inclusion criteria include: age>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain.
Exclusion criteria include: pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (>1.5) or low platelet count (<75 cells/mm3), allergy to eggs or "caine" anesthetics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-celiac plexus block (EUS-CPB) | Other | Procedure: EUS-celiac plexus block (EUS-CPB)This is the standard technique. In this approach, the needle is passed through the body of the stomach adjacent the celiac artery into the retroperitoneal space in 1 or 2 passes. The injectate (bupivacaine or alcohol) is injected and spreads through the retroperitoneal space, effectively "bathing" all the ganglia. |
| EUS-celiac ganglia block (EUS-CGB) | Active comparator | Procedure: EUS-celiac ganglia block (EUS-CGB)This is a more recent technique which has been often used. In this procedure, the needle is inserted under EUS guidance directly into as many ganglia as possible. For celiac ganglia <1cm in diameter, the solution is injected into the central point; for those ≥1 cm, a needle is advanced to the deepest point into the ganglia and solution is injected as the needle is slowly withdrawn. Injections are continued until an echogenic pattern is produced over the entire celiac ganglia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with chronic pancreatitis and referred for EUS-guided celiac plexus block with: age>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain.
Key exclusion criteria (1 listed)
- pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (>1.5) or low platelet count (<75 cells/mm3), allergy to eggs or "caine" anesthetics.
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 |
|---|---|---|
| EUS-celiac ganglia block (EUS-CGB)The intervention technique of EUS-CGB is the realization of EUS-guided celiac block with injection of bupivacaine directly into the ganglia for patients with chronic pancreatitis. | Procedure or surgery | EUS-celiac ganglia block (EUS-CGB) |
| EUS-celiac plexus block (EUS-CPB)In the arm of EUS-CPB, the procedure is going to be performed with the standard EUS-guided celiac plexus block with injection of bupivacaine into the retroperitoneal space. | Procedure or surgery | EUS-celiac plexus block (EUS-CPB) |
Primary outcome
Pain relief
Time frame: 1 week
The primary endpoint will be pain relief at 1 week after the block, defined as a decrease of 3 or more points in the VAS scale measuring "average pain over past week".
4 secondary outcomes
Complete response rate
Time frame: 1 week
Duration of pain relief
Time frame: up to 2 months
Opioid consumption
Time frame: up to 2 months
Adverse effects
Time frame: in up to 2 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 17 Apr 2020.
- Background: PubMed 23616126Doi S, Yasuda I, Kawakami H, Hayashi T, Hisai H, Irisawa A, Mukai T, Katanuma A, Kubota K, Ohnishi T, Ryozawa S, Hara K, Itoi T, Hanada K, Yamao K. Endoscopic ultrasound-guided celiac ganglia neurolysis vs. celiac plexus neurolysis: a randomized multicenter trial. Endoscopy. 2013;45(5):362-9. doi: 10.1055/s-0032-1326225. Epub 2013 Apr 24.
- Background: PubMed 21295640Ascunce G, Ribeiro A, Reis I, Rocha-Lima C, Sleeman D, Merchan J, Levi J. EUS visualization and direct celiac ganglia neurolysis predicts better pain relief in patients with pancreatic malignancy (with video). Gastrointest Endosc. 2011 Feb;73(2):267-74. doi: 10.1016/j.gie.2010.10.029.
- Individual participant dataSharing planned: No
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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.
Tyler Stevens, MD study director
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-celiac ganglia block (EUS-CGB) and EUS-celiac plexus block (EUS-CPB) in people with Pancreatitis, Chronic and Abdominal Pain, run by The Cleveland Clinic 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 1 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 17 Apr 2020. 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?
Pain relief (time frame: 1 week). 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 NCT03070210, which also lists 2 linked publications.
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 17 Apr 2020.