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

May 12, 2020 updated by: A Sahai, Centre hospitalier de l'Université de Montréal (CHUM)

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • CHUM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in pain scores at 1 month and end of the trial
Time Frame: 1 month and 120 days post procedure
1 month and 120 days post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 month and 120 days post procedure
Difference in cumulative narcotic usage at 1 month and end of the trial
Time Frame: 1 month and 120 days post procedure
1 month and 120 days post procedure
Difference in survival
Time Frame: 1 month and 120 days post procedure
1 month and 120 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Anand Sahai, M.D, Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2016

Primary Completion (Actual)

June 14, 2019

Study Completion (Actual)

June 14, 2019

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 15.246

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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