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Trial of Endoscopic Ultrasound (EUS) - Guided Celiac Plexus Neurolysis

Primary Purpose

Inoperable, Painful Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
EUS-guided celiac plexus neurolysis
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inoperable, Painful Pancreatic Cancer focused on measuring Pancreatic cancer, Therapy, Neurolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • previous imaging and/or the EUS examination demonstrated inoperable pancreatic cancer defined as involvement of the superior mesenteric vein, portal vein or confluence, superior mesenteric artery, celiac axis, hepatic artery, or non-regional lymphadenopathy
  • a new diagnosis of pancreatic adenocarcinoma was confirmed by an on-site cytopathologist following EUS fine needle aspiration (EUS-FNA)

Exclusion Criteria:

  • allergy to bupivicaine
  • possible future surgical management of the tumor
  • expected survival less than 3months (suspected or proven carcinomatosis or liver metastases)
  • inability or unwillingness to provide informed consent prior to the EUS

Sites / Locations

  • CHUM

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Neurolysis

Conventional therapy

Arm Description

Patients will undergo EUS followed by EUS-guided, bilateral neurolysis with bupivicaine and absolute alcohol.

EUS will be performed with no celiac plexus neurolysis.

Outcomes

Primary Outcome Measures

Absolute and relative changes in 7-point Likert-score for abdominal pain at 1 and 3 months post-randomization. Secondary endpoints were change in morphine equivalent consumption (MEQ), quality of life (DDQ-15), and overall survival.

Secondary Outcome Measures

2. Quality of life 3. Survival

Full Information

First Posted
September 10, 2009
Last Updated
September 10, 2009
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT00974948
Brief Title
Trial of Endoscopic Ultrasound (EUS) - Guided Celiac Plexus Neurolysis
Official Title
A Randomized, Double Blind, Sham-Controlled Trial of EUS-Guided Celiac Plexus Neurolysis (EUS-CPN) for Pain Due to Newly Diagnosed, Inoperable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pancreatic cancer presents with pain in the majority of cases. Destruction of the celiac ganglia by ultrasound guided injection of sclerosing agents such as alcohol is sometimes used for pain that no longer responds to treatment with narcotics. The investigators compare standard narcotic treatment to celiac plexus alcohol injection (celiac plexus neurolysis) and do so in patients with early, mild pain to see if celiac plexus neurolysis is more effective than narcotics and prevents escalating narcotic use.
Detailed Description
This is a randomized, double blind, sham-controlled trial designed to evaluate the efficacy of early EUS-guided celiac plexus neurolysis (EUS-CPN). "Early" refers to the fact that, in contrast to previous CPN trials, we targeted patients with inoperable, painful pancreatic cancer in whom pain was mild and who were taking little or no narcotics. Our a priori hypotheses were that, compared to conventional management with narcotics alone, early neurolysis: 1) will better control pain related to inoperable pancreatic cancer, 2) will prevent the escalating use of narcotics associated with disease progression, 3) will improve quality of life, and 4) will improve survival. The aim our study is to test these 4 hypotheses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inoperable, Painful Pancreatic Cancer
Keywords
Pancreatic cancer, Therapy, Neurolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurolysis
Arm Type
Active Comparator
Arm Description
Patients will undergo EUS followed by EUS-guided, bilateral neurolysis with bupivicaine and absolute alcohol.
Arm Title
Conventional therapy
Arm Type
No Intervention
Arm Description
EUS will be performed with no celiac plexus neurolysis.
Intervention Type
Procedure
Intervention Name(s)
EUS-guided celiac plexus neurolysis
Intervention Description
Injection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis.
Primary Outcome Measure Information:
Title
Absolute and relative changes in 7-point Likert-score for abdominal pain at 1 and 3 months post-randomization. Secondary endpoints were change in morphine equivalent consumption (MEQ), quality of life (DDQ-15), and overall survival.
Time Frame
1 month, 3 months
Secondary Outcome Measure Information:
Title
2. Quality of life 3. Survival
Time Frame
1 month, 3 months and until death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: previous imaging and/or the EUS examination demonstrated inoperable pancreatic cancer defined as involvement of the superior mesenteric vein, portal vein or confluence, superior mesenteric artery, celiac axis, hepatic artery, or non-regional lymphadenopathy a new diagnosis of pancreatic adenocarcinoma was confirmed by an on-site cytopathologist following EUS fine needle aspiration (EUS-FNA) Exclusion Criteria: allergy to bupivicaine possible future surgical management of the tumor expected survival less than 3months (suspected or proven carcinomatosis or liver metastases) inability or unwillingness to provide informed consent prior to the EUS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Sahai, MD
Organizational Affiliation
CHUM, Universite de Montreal
Official's Role
Study Director
Facility Information:
Facility Name
CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada

12. IPD Sharing Statement

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Trial of Endoscopic Ultrasound (EUS) - Guided Celiac Plexus Neurolysis

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