Intraductal Liposomal Bupivacaine for Chronic Pancreatitis

NCT04611958 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: IRB00268695
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after the ERCP

Secondary Outcomes (3)

• Change in the pain score at 2 hours after ERCP

  2 hours after ERCP

• Change in the pain score at 48 hours after ERCP

  48 hours after ERCP

• Change in the pain score at 72 hours after ERCP

  72 hours after ERCP

Study Arms (1)

Bupivacaine arm

EXPERIMENTAL

Participants undergoing ERCP as part of routine clinical care will be consented for this study.

Drug: ERCP with Bupivacaine infusion

Interventions

ERCP with Bupivacaine infusion DRUG

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 The canula will be taken to the tail of the pancreatic duct, and gradually withdrawn with slow infusion of the bupivacaine solution.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.

Bupivacaine arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Significant liver or renal dysfunction.
• Any Contraindication of ERCP.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hopital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Pankaj Pasricha, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 2, 2020
• Study Start: July 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)