Chronic PancreatitisEarly Phase 1NCT04611958
Intraductal Liposomal Bupivacaine for Chronic Pancreatitis
A Early Phase 1 study testing ERCP with Bupivacaine infusion in people with Chronic Pancreatitis, run by Johns Hopkins University at 1 site in United States.
Trial summary
The major clinical features of chronic pancreatitis include glandular (exocrine and endocrine) failure and pain. Pain has remained a major clinical challenge and is present in up to 90% of patients and is the primary cause of hospitalization in most patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- ERCP with Bupivacaine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Jul 2021
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed consent
- Age >18 years
- Patients with an established diagnosis of chronic pancreatitis with constant daily pain consistent with the same and not relieved despite standard clinical care for at least 6 months and in whom ERCP is indicated for standard of care.
Who cannot join
- Significant liver or renal dysfunction.
- Any Contraindication of ERCP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraductal Liposomal Bupivacaine as a Therapeutic Trial to Determine the Contribution of Peripheral Versus Central Sensitization in the Pathogenesis of Pain in Chronic Pancreatitis- a Pilot and Feasibility Study
The major clinical features of chronic pancreatitis include glandular (exocrine and endocrine) failure and pain. Pain has remained a major clinical challenge and is present in up to 90% of patients and is the primary cause of hospitalization in most patients. Unfortunately, pain in chronic pancreatitis has been very difficult to treat.
The investigators hypothesize that the best method to reliably abolish peripheral nerve signaling is the use of a local anesthetic within the target organ (i.e. pancreas). This can best be done during endoscopic retrograde cholangiopancreatography (ERCP).
Since ERCP is done under deep sedation or general anesthesia, it is critical to select a local anesthetic whose effect persists well after recovery from the procedure; if not, the assessment of the effect of the local anesthetic on pain will be impossible to assess. The investigators have therefore chosen liposomal bupivacaine (Exparel, Pacira Pharmaceuticals), which is an FDA approved product for local infiltration that has a longer duration of action (up to 72 hours) and a slower absorption into the systemic circulation, avoiding high plasma concentrations.
Read the detailed description
The major clinical features of chronic pancreatitis include glandular (exocrine and endocrine) failure and pain. The former can usually be managed satisfactorily by replacement strategies (enzymes or insulin) to restore nutritional and metabolic stability. However, pain has remained a major clinical challenge and is present in up to 90% of patients and is the primary cause of hospitalization in most patients. Unfortunately, pain in chronic pancreatitis has been very difficult to treat, and the investigators' lack of understanding about the underlying biology has led to various empirical approaches that are often based on purely anatomical grounds, and are generally highly invasive. Significant tissue injury such as that observed in chronic pancreatitis not only triggers nociceptor activation but over time, can also increase the pain in the whole system, a process called sensitization.
Determination of the contribution of peripheral versus central factors to nociceptive sensitization has significant clinical implications in an individual patient. Thus, if pain is caused primarily by signals emanating in the peripheral nerves, then perhaps invasive procedures directed against the pancreas (including pancreatectomy) are justified and can be expected to have a high probability of success. On the other hand, if central sensitization is the dominant pathophysiological factor, then these procedures may cause more harm than good and the patient may be best served using aggressive neuromodulator therapies.
The most direct way to address this question is to interrupt peripheral nerve signaling and determine how much of the pain, if any, is taken away. Unfortunately, there are no satisfactory methods to do this currently. Although celiac or splanchnic nerve blocks have been used for the treatment of pain in chronic pancreatitis, the treatments have had limited success for a variety of reasons, including the fact that the technique may not always be accurate in terms of the site of injection.
The investigators hypothesize that the best method to reliably abolish peripheral nerve signaling is the use of a local anesthetic within the target organ (i.e. pancreas). This can best be done during endoscopic retrograde cholangiopancreatography (ERCP), a technique in which the main pancreatic duct is cannulated with the help of a duodenoscope and contrast material injected. This technique is routinely done to assess pancreatic duct anatomy prior to consideration of a therapeutic intervention such as a stent, stricture dilation, or stone removal/lithotripsy.
Since ERCP is done under deep sedation or general anesthesia, it is critical to select a local anesthetic whose effect persists well after recovery from the procedure; if not, the assessment of the effect of the local anesthetic on pain will be impossible to assess. The investigators have therefore chosen liposomal bupivacaine (Exparel, Pacira Pharmaceuticals), which is an FDA approved product for local infiltration that has a longer duration of action (up to 72 hours) and a slower absorption into the systemic circulation, avoiding high plasma concentrations.
- Conditions
- Chronic Pancreatitis
- Being tested
- ERCP with Bupivacaine infusion
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP with Bupivacaine infusionDrug
Selective cannulation of the pancreatic duct with ERCP scope will be performed. Any contrast dye used will be carefully aspirated and the duct will be flushed with saline as necessary to clear all residual dye. The canula will be taken to the tail of the pancreatic duct, and gradually withdrawn with slow infusion of the bupivacaine solution. Liposomal bupivacaine (13.3 mg/ml of Exparel) will be injected into the main pancreatic duct for a total of 5-10 ml (depending on the length of the pancreatic duct).
Immediately after the procedure, the patient will be monitored for any evidence of acute pancreatitis (worsening abdominal pain, with amylase or lipase x3 upper limit of normal). The patient will be questioned daily after the procedure for common side effects of bupivacaine including nausea, fever, change in taste, dizziness, weakness, palpitations and loss of taste or any other new or unusual symptom.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine arm | Experimental | Participants undergoing ERCP as part of routine clinical care will be consented for this study. Receives: Drug: ERCP with Bupivacaine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the pain score at 24 hours after ERCP
Raw pain score using a visual analog scale from 0 to 10, being 0 no pain and 10 the worst pain the participant can imagine.
Measured: 24 hours after the ERCP
Secondary outcomes (3)
Change in the pain score at 2 hours after ERCP
Raw pain score using a visual analog scale from 0 to 10, being 0 no pain and 10 the worst pain the participant can imagine.
Measured: 2 hours after ERCP
Change in the pain score at 48 hours after ERCP
Raw pain score using a visual analog scale from 0 to 10, being 0 no pain and 10 the worst pain the participant can imagine.
Measured: 48 hours after ERCP
Change in the pain score at 72 hours after ERCP
Raw pain score using a visual analog scale from 0 to 10, being 0 no pain and 10 the worst pain the participant can imagine.
Measured: 72 hours after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Jul 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: The FDA requirements for the IND are not feasible to complete.
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.
- More trials run by Johns Hopkins 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pankaj Pasricha, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611958
- Sponsor's protocol ID
- IRB00268695
- Status last verified
- Jul 2021
- First submitted
- 27 Oct 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraductal Liposomal Bupivacaine as a Therapeutic Trial to Determine the Contribution of Peripheral Versus Central Sensitization in the Pathogenesis of Pain in Chronic Pancreatitis- a Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT04611958
- Acronym / sponsor ID
- IRB00268695
- Conditions
- Chronic Pancreatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The FDA requirements for the IND are not feasible to complete.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 2 Nov 2020 (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.
The major clinical features of chronic pancreatitis include glandular (exocrine and endocrine) failure and pain. Pain has remained a major clinical challenge and is present in up to 90% of patients and is the primary cause of hospitalization in most patients. Unfortunately, pain in chronic pancreatitis has been very difficult to treat.
The investigators hypothesize that the best method to reliably abolish peripheral nerve signaling is the use of a local anesthetic within the target organ (i.e. pancreas). This can best be done during endoscopic retrograde cholangiopancreatography (ERCP).
Since ERCP is done under deep sedation or general anesthesia, it is critical to select a local anesthetic whose effect persists well after recovery from the procedure; if not, the assessment of the effect of the local anesthetic on pain will be impossible to assess. The investigators have therefore chosen liposomal bupivacaine (Exparel, Pacira Pharmaceuticals), which is an FDA approved product for local infiltration that has a longer duration of action (up to 72 hours) and a slower absorption into the systemic circulation, avoiding high plasma concentrations.
Detailed description
The major clinical features of chronic pancreatitis include glandular (exocrine and endocrine) failure and pain. The former can usually be managed satisfactorily by replacement strategies (enzymes or insulin) to restore nutritional and metabolic stability. However, pain has remained a major clinical challenge and is present in up to 90% of patients and is the primary cause of hospitalization in most patients. Unfortunately, pain in chronic pancreatitis has been very difficult to treat, and the investigators' lack of understanding about the underlying biology has led to various empirical approaches that are often based on purely anatomical grounds, and are generally highly invasive. Significant tissue injury such as that observed in chronic pancreatitis not only triggers nociceptor activation but over time, can also increase the pain in the whole system, a process called sensitization.
Determination of the contribution of peripheral versus central factors to nociceptive sensitization has significant clinical implications in an individual patient. Thus, if pain is caused primarily by signals emanating in the peripheral nerves, then perhaps invasive procedures directed against the pancreas (including pancreatectomy) are justified and can be expected to have a high probability of success. On the other hand, if central sensitization is the dominant pathophysiological factor, then these procedures may cause more harm than good and the patient may be best served using aggressive neuromodulator therapies.
The most direct way to address this question is to interrupt peripheral nerve signaling and determine how much of the pain, if any, is taken away. Unfortunately, there are no satisfactory methods to do this currently. Although celiac or splanchnic nerve blocks have been used for the treatment of pain in chronic pancreatitis, the treatments have had limited success for a variety of reasons, including the fact that the technique may not always be accurate in terms of the site of injection.
The investigators hypothesize that the best method to reliably abolish peripheral nerve signaling is the use of a local anesthetic within the target organ (i.e. pancreas). This can best be done during endoscopic retrograde cholangiopancreatography (ERCP), a technique in which the main pancreatic duct is cannulated with the help of a duodenoscope and contrast material injected. This technique is routinely done to assess pancreatic duct anatomy prior to consideration of a therapeutic intervention such as a stent, stricture dilation, or stone removal/lithotripsy.
Since ERCP is done under deep sedation or general anesthesia, it is critical to select a local anesthetic whose effect persists well after recovery from the procedure; if not, the assessment of the effect of the local anesthetic on pain will be impossible to assess. The investigators have therefore chosen liposomal bupivacaine (Exparel, Pacira Pharmaceuticals), which is an FDA approved product for local infiltration that has a longer duration of action (up to 72 hours) and a slower absorption into the systemic circulation, avoiding high plasma concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine arm | Experimental | Drug: ERCP with Bupivacaine infusionParticipants undergoing ERCP as part of routine clinical care will be consented for this study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed consent
- Age >18 years
- Patients with an established diagnosis of chronic pancreatitis with constant daily pain consistent with the same and not relieved despite standard clinical care for at least 6 months and in whom ERCP is indicated for standard of care.
Key exclusion criteria (2 listed)
- Significant liver or renal dysfunction.
- Any Contraindication of ERCP.
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 |
|---|---|---|
| ERCP with Bupivacaine infusionSelective cannulation of the pancreatic duct with ERCP scope will be performed. Any contrast dye used will be carefully aspirated and the duct will be flushed with saline as necessary to clear all residual dye. The canula will be taken to the tail of the pancreatic duct, and gradually withdrawn with slow infusion of the bupivacaine solution. Liposomal bupivacaine (13.3 mg/ml of Exparel) will be injected into the main pancreatic duct for a total of 5-10 ml (depending on the length of the pancreatic duct). Immediately after the procedure, the patient will be monitored for any evidence of acute pancreatitis (worsening abdominal pain, with amylase or lipase x3 upper limit of normal). The patient will be questioned daily after the procedure for common side effects of bupivacaine including nausea, fever, change in taste, dizziness, weakness, palpitations and loss of taste or any other new or unusual symptom. | Drug | Bupivacaine arm |
Primary outcome
Change in the pain score at 24 hours after ERCP
Time frame: 24 hours after the ERCP
Raw pain score using a visual analog scale from 0 to 10, being 0 no pain and 10 the worst pain the participant can imagine.
3 secondary outcomes
Change in the pain score at 2 hours after ERCP
Time frame: 2 hours after ERCP
Change in the pain score at 48 hours after ERCP
Time frame: 48 hours after ERCP
Change in the pain score at 72 hours after ERCP
Time frame: 72 hours after ERCP
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- 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.
Pankaj Pasricha, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ERCP with Bupivacaine infusion in people with Chronic Pancreatitis, run by Johns Hopkins 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 21 Jul 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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 the pain score at 24 hours after ERCP (time frame: 24 hours after the ERCP). 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 21 Jul 2021.