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EUS Guided Neurolysis Celiac Block w/wo Bupivacaine in Patient Being Treated Palliatively for Pancreatic Cancer (EUS-CPN)

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ClinicalTrials.gov Identifier: NCT02682082
Recruitment Status : Unknown
Verified August 2017 by A Sahai, Centre hospitalier de l'Université de Montréal (CHUM).
Recruitment status was:  Active, not recruiting
First Posted : February 15, 2016
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
A Sahai, Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
The goal of this project is to determine if EUS-CPN without Bupivacaine (versus EUS-CPN with Bupivacaine) can reduce pain scores and improve quality of life in patients with inoperable pancreatic cancer by reducing the morbidity due to narcotic side effects (e.g. nausea, excessive sedation, constipation).

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: Endoscopic ultrasound-guided celiax plexus neurolysis Drug: Bupivacaine Not Applicable

Detailed Description:

Pancreatic malignancies are the second highest incident gastrointestinal malignancy in Canada. From cancer mortality statistics in 2014, there were 4,700 new cases of pancreatic malignancies second only to colorectal cancer, representing 2.4% of all cancers . Even with chemotherapy, the median survival for patients with pancreatic adenocarcinoma is 6 to 10 months. Few of the patients are diagnosed at a resectable stage (12%-20%) so many patients are candidates for palliation only.In this context, one of the most important symptoms is pain because it often affects both quality of life and survival.70 to 80 % of patients with Pancreatic cancer had abdominal pain at the time of diagnosis . Adequate pain control is therefore an essential component of care in these patients. In the initial phase, the pain is visceral, but with disease progression, somatic pain may occur, especially due to the peripancreatic invasion of neural structures or muscles. Standard analgesics such as Acetaminophen are ineffective and administration of opioids is frequently limited by side effects such as nausea, constipation, somnolence, addiction, confusion or respiratory depression, and failure in achieving adequate analgesia. In these situations, neurodestructive methods of celiac plexus with Absolute Alcohol associated to Bupivacaine involving the main pancreatic pain pathways, seem efficient. Alcohol causes the immediate precipitation of endoneural lipoproteins and mucoproteins within the celiac plexus, leading to the extraction of cholesterol and phospholipids from the neural membrane. To prevent severe transient pain after the procedure, Bupivacaine was injected before the Alcohol injection. Interest and importance of EUS-CPN is well established (safe, more effective than percutaneous or CT guided celiac plexus Neurolysis, significant reduction in pain and significant reduction of narcotics requirements) however the role and effect of Bupivacaine on the effectiveness of Neurolysis and lytic power of Alcohol has never been studied . Is it a synergistic effect ? Or an antagonistic effect by diluting Alcohol ? The Centre hospitalier de l'université de Montréal (CHUM) is currently the busiest EUS center in the world and has the largest experience with EUS-guided CPN. The CHUM also probably see more pancreatic cancers annually than any other center (more than 300 proven cases/year). There are no published reports of serious adverse events associated with this procedure and this has been the investigators experience as well. Patients may however experience some mild to moderate discomfort during the initial injection of the absolute ethanol solution, but this is usually short lived (less than 30 minutes in our experience). Therefore, Bupivacaine is currently injected before the Ethanol injection, however, local anesthetic was not used before the Phenol injection for example because it has been reported that Phenol has an immediate local anesthetic effect.

The investigators believe that, Bupivacaine has no effect and instead it dilutes the alcohol and then reduces the lytic power of Ethanol. This study was designed to test this hypothesis prospectively.

The goal of this project is to determine if EUS-CPN without Bupivacaine (versus EUS-CPN with Bupivacaine) can reduce pain scores and improve quality of life in patients with inoperable pancreatic cancer by reducing the morbidity due to narcotic side effects (e.g. nausea, excessive sedation, constipation).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomize Double-Blind Control Trial Study Comparing Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis W/Wo Bupivacaine In Patient Being Treated Palliatively For Pancreatic Cancer
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019


Arm Intervention/treatment
Experimental: Neurolysis without Bupivacaine
Experimental Group: Endoscopic ultrasound guided celiac plexus Neurolysis without Bupivacaine so only with Absolute Alcohol 20 mL
Procedure: Endoscopic ultrasound-guided celiax plexus neurolysis
Endoscopic ultrasound-guided celiax plexus neurolysis

Active Comparator: Neurolysis with Bupivacaine
Endoscopic ultrasound guided celiac plexus Neurolysis with Bupivacaine (0.5% Bupivicaine 20mL + Absolute Alcohol 20 mL)
Procedure: Endoscopic ultrasound-guided celiax plexus neurolysis
Endoscopic ultrasound-guided celiax plexus neurolysis

Drug: Bupivacaine
Endoscopic ultrasound-guided celiax plexus neurolysis w/wo Bupivacaine




Primary Outcome Measures :
  1. Difference in pain scores at 1 month and end of the trial [ Time Frame: 1 month and 120 days post procedure ]

Secondary Outcome Measures :
  1. Difference in quality of life scores at 1 month and end of the trial [ Time Frame: 1 month and 120 days post procedure ]
    Quality of life will be measured using the DDQ 15 quality of life instrument (a validated 15-question instrument specific for diseases of the digestive system)

  2. Difference in cumulative narcotic usage at 1 month and end of the trial [ Time Frame: 1 month and 120 days post procedure ]
  3. Difference in survival [ Time Frame: 1 month and 120 days post procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed malignant pancreatic lesion involving the pancreatic genu, body, or tail
  • Abdominal or back pain considered to be potentially related to the tumor

    • New onset pain (<3 months)
    • Constant
    • Centrally located
    • With or without irradiation to the back
    • No obvious other source of pain based on history and physical examination by the attending endosonographer
  • No possibility of surgical management
  • Signed, informed consent

Exclusion Criteria:

  • Allergy to bupivicaine
  • Age < 18 years
  • Inability or unwillingness to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682082


Locations
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Canada, Quebec
CHUM
Montreal, Quebec, Canada
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Anand Sahai, M.D Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal)

Publications:

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Responsible Party: A Sahai, Professeur Titulaire de Médecine / Professor of Medicine Chef / Chief, Service de Gastroentérologie, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02682082     History of Changes
Other Study ID Numbers: CE 15.246
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Keywords provided by A Sahai, Centre hospitalier de l'Université de Montréal (CHUM):
Pancreatic cancer
Pain Management
Celiac plexus neurolysis
Bupivacaine
Palliative treatment
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Bupivacaine
Anesthetics, Local
Anesthetics
Physiological Effects of Drugs