Inoperable, Painful Pancreatic CancerPhase 3NCT00974948
Trial of Endoscopic Ultrasound (EUS) - Guided Celiac Plexus Neurolysis
A Phase 3 study testing EUS-guided celiac plexus neurolysis in people with Inoperable, Painful Pancreatic Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inoperable, Painful Pancreatic Cancer
- What is being tested?
- EUS-guided celiac plexus neurolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Dec 2008
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Inoperable, Painful Pancreatic Cancer
- Being tested
- EUS-guided celiac plexus neurolysis
- Keywords
- Pancreatic cancer, Therapy, Neurolysis
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided celiac plexus neurolysisProcedure or surgery
Injection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis.
| Study group | Role | What they receive |
|---|---|---|
| Neurolysis | Active comparator | Patients will undergo EUS followed by EUS-guided, bilateral neurolysis with bupivicaine and absolute alcohol. Receives: Procedure: EUS-guided celiac plexus neurolysis |
| Conventional therapy | No intervention | EUS will be performed with no celiac plexus neurolysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month, 3 months
Secondary outcomes (1)
2. Quality of life 3. Survival
Measured: 1 month, 3 months and until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startApr 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inoperable, Painful Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anand Sahai, MD, Study director, CHUM, Universite de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974948
- Sponsor's protocol ID
- ND05.083
- Status last verified
- Aug 2026
- First submitted
- 10 Sep 2009
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00974948
- Acronym / sponsor ID
- ND05.083
- Conditions
- Inoperable, Painful Pancreatic Cancer
- Keywords
- Pancreatic cancer, Therapy, Neurolysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Sep 2009 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurolysis | Active comparator | Procedure: EUS-guided celiac plexus neurolysisPatients will undergo EUS followed by EUS-guided, bilateral neurolysis with bupivicaine and absolute alcohol. |
| Conventional therapy | No intervention | –EUS will be performed with no celiac plexus neurolysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| EUS-guided celiac plexus neurolysisInjection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis. | Procedure or surgery | Neurolysis |
Primary outcome
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
1 secondary outcome
2. Quality of life 3. Survival
Time frame: 1 month, 3 months and until death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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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.
Anand Sahai, MD study director
CHUM, Universite de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EUS-guided celiac plexus neurolysis in people with Inoperable, Painful Pancreatic Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 14 Aug 2026. 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 Canada. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 14 Aug 2026.