Pancreatic CancerEUS-CPNNCT02682082
EUS Guided Neurolysis Celiac Block w/wo Bupivacaine in Patient Being Treated Palliatively for Pancreatic Cancer
A study testing Endoscopic ultrasound-guided celiax plexus neurolysis and Bupivacaine in people with Pancreatic Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Endoscopic ultrasound-guided celiax plexus neurolysis and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 27 May 2016to 14 Jun 2019
- Phase
- Interventional
- 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
- 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
Show all 9Show fewer
- No obvious other source of pain based on history and physical examination by the attending endosonographer
- No possibility of surgical management
- Signed, informed consent
Who cannot join
- Allergy to bupivicaine
- Age < 18 years
- Inability or unwillingness to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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).
- Conditions
- Pancreatic Cancer
- Being tested
- Endoscopic ultrasound-guided celiax plexus neurolysis, Bupivacaine
- Keywords
- Pancreatic cancer, Pain Management, Celiac plexus neurolysis, Bupivacaine, Palliative treatment
- Medical subject headings
- Pancreatic Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound-guided celiax plexus neurolysisProcedure or surgery
Endoscopic ultrasound-guided celiax plexus neurolysis
BupivacaineDrug
Endoscopic ultrasound-guided celiax plexus neurolysis w/wo Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Neurolysis without Bupivacaine | Experimental | Experimental Group: Endoscopic ultrasound guided celiac plexus Neurolysis without Bupivacaine so only with Absolute Alcohol 20 mL Receives: Procedure: Endoscopic ultrasound-guided celiax plexus neurolysis |
| Neurolysis with Bupivacaine | Active comparator | Endoscopic ultrasound guided celiac plexus Neurolysis with Bupivacaine (0.5% Bupivicaine 20mL + Absolute Alcohol 20 mL) Receives: Procedure: Endoscopic ultrasound-guided celiax plexus neurolysis; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain scores at 1 month and end of the trial
Measured: 1 month and 120 days post procedure
Secondary outcomes (3)
Difference in quality of life scores at 1 month and end of the trial
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)
Measured: 1 month and 120 days post procedure
Difference in cumulative narcotic usage at 1 month and end of the trial
Measured: 1 month and 120 days post procedure
Difference in survival
Measured: 1 month and 120 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start27 May 2016
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
Why it stopped: Closed by CHUM REB for incomplete documentation of research activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A Sahai, Centre hospitalier de l'Université de Montréal (CHUM)
- Investigators
- Anand Sahai, M.D, Principal investigator, Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682082
- Sponsor's protocol ID
- CE 15.246
- Acronym
- EUS-CPN
- Status last verified
- May 2020
- First submitted
- 8 Feb 2016
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Seicean A. Celiac plexus neurolysis in pancreatic cancer: the endoscopic ultrasound approach. World J Gastroenterol. 2014 Jan 7;20(1):110-7. doi: 10.3748/wjg.v20.i1.110.
PubMed 24415863Wyse JM, Chen YI, Sahai AV. Celiac plexus neurolysis in the management of unresectable pancreatic cancer: when and how? World J Gastroenterol. 2014 Mar 7;20(9):2186-92. doi: 10.3748/wjg.v20.i9.2186.
PubMed 24605017Seicean A, Cainap C, Gulei I, Tantau M, Seicean R. Pain palliation by endoscopic ultrasound-guided celiac plexus neurolysis in patients with unresectable pancreatic cancer. J Gastrointestin Liver Dis. 2013 Mar;22(1):59-64.
PubMed 23539392Levy MJ, Chari ST, Wiersema MJ. Endoscopic ultrasound-guided celiac neurolysis. Gastrointest Endosc Clin N Am. 2012 Apr;22(2):231-47, viii. doi: 10.1016/j.giec.2012.04.003. Epub 2012 Apr 25.
PubMed 22632946Sakamoto H, Kitano M, Komaki T, Imai H, Kamata K, Kudo M. Endoscopic ultrasound-guided neurolysis in pancreatic cancer. Pancreatology. 2011;11 Suppl 2:52-8. doi: 10.1159/000323513. Epub 2011 Apr 5.
PubMed 21471704Penman ID. Coeliac plexus neurolysis. Best Pract Res Clin Gastroenterol. 2009;23(5):761-6. doi: 10.1016/j.bpg.2009.05.003.
PubMed 19744638Ishiwatari H, Hayashi T, Yoshida M, Ono M, Masuko H, Sato T, Miyanishi K, Sato Y, Takimoto R, Kobune M, Miyamoto A, Sonoda T, Kato J. Phenol-based endoscopic ultrasound-guided celiac plexus neurolysis for East Asian alcohol-intolerant upper gastrointestinal cancer patients: a pilot study. World J Gastroenterol. 2014 Aug 14;20(30):10512-7. doi: 10.3748/wjg.v20.i30.10512.
PubMed 25132769
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02682082
- Acronym / sponsor ID
- EUS-CPN / CE 15.246
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Pain Management, Celiac plexus neurolysis, Bupivacaine, Palliative treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed by CHUM REB for incomplete documentation of research activities.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 27 May 2016 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 15 Feb 2016 (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.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurolysis without Bupivacaine | Experimental | Procedure: Endoscopic ultrasound-guided celiax plexus neurolysisExperimental Group: Endoscopic ultrasound guided celiac plexus Neurolysis without Bupivacaine so only with Absolute Alcohol 20 mL |
| Neurolysis with Bupivacaine | Active comparator | Procedure: Endoscopic ultrasound-guided celiax plexus neurolysis, Drug: BupivacaineEndoscopic ultrasound guided celiac plexus Neurolysis with Bupivacaine (0.5% Bupivicaine 20mL + Absolute Alcohol 20 mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed malignant pancreatic lesion involving the pancreatic genu, body, or tail
- Abdominal or back pain considered to be potentially related to the tumor
- No possibility of surgical management
- Signed, informed consent
Key exclusion criteria (3 listed)
- Allergy to bupivicaine
- Age < 18 years
- Inability or unwillingness to give informed consent
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 |
|---|---|---|
| Endoscopic ultrasound-guided celiax plexus neurolysisEndoscopic ultrasound-guided celiax plexus neurolysis | Procedure or surgery | Neurolysis with Bupivacaine, Neurolysis without Bupivacaine |
| BupivacaineEndoscopic ultrasound-guided celiax plexus neurolysis w/wo Bupivacaine | Drug | Neurolysis with Bupivacaine |
Primary outcome
Difference in pain scores at 1 month and end of the trial
Time frame: 1 month and 120 days post procedure
3 secondary outcomes
Difference in quality of life scores at 1 month and end of the trial
Time frame: 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
Difference in survival
Time frame: 1 month and 120 days post procedure
Results and safety
The study was stopped early (reason given: Closed by CHUM REB for incomplete documentation of research activities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Background: PubMed 24415863Seicean A. Celiac plexus neurolysis in pancreatic cancer: the endoscopic ultrasound approach. World J Gastroenterol. 2014 Jan 7;20(1):110-7. doi: 10.3748/wjg.v20.i1.110.
- Background: PubMed 24605017Wyse JM, Chen YI, Sahai AV. Celiac plexus neurolysis in the management of unresectable pancreatic cancer: when and how? World J Gastroenterol. 2014 Mar 7;20(9):2186-92. doi: 10.3748/wjg.v20.i9.2186.
- Background: PubMed 23539392Seicean A, Cainap C, Gulei I, Tantau M, Seicean R. Pain palliation by endoscopic ultrasound-guided celiac plexus neurolysis in patients with unresectable pancreatic cancer. J Gastrointestin Liver Dis. 2013 Mar;22(1):59-64.
- Background: PubMed 22632946Levy MJ, Chari ST, Wiersema MJ. Endoscopic ultrasound-guided celiac neurolysis. Gastrointest Endosc Clin N Am. 2012 Apr;22(2):231-47, viii. doi: 10.1016/j.giec.2012.04.003. Epub 2012 Apr 25.
- Background: PubMed 21471704Sakamoto H, Kitano M, Komaki T, Imai H, Kamata K, Kudo M. Endoscopic ultrasound-guided neurolysis in pancreatic cancer. Pancreatology. 2011;11 Suppl 2:52-8. doi: 10.1159/000323513. Epub 2011 Apr 5.
- Background: PubMed 19744638Penman ID. Coeliac plexus neurolysis. Best Pract Res Clin Gastroenterol. 2009;23(5):761-6. doi: 10.1016/j.bpg.2009.05.003.
- Background: PubMed 25132769Ishiwatari H, Hayashi T, Yoshida M, Ono M, Masuko H, Sato T, Miyanishi K, Sato Y, Takimoto R, Kobune M, Miyamoto A, Sonoda T, Kato J. Phenol-based endoscopic ultrasound-guided celiac plexus neurolysis for East Asian alcohol-intolerant upper gastrointestinal cancer patients: a pilot study. World J Gastroenterol. 2014 Aug 14;20(30):10512-7. doi: 10.3748/wjg.v20.i30.10512.
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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, M.D principal investigator
Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound-guided celiax plexus neurolysis and Bupivacaine in people with 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 9 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 May 2020. 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.
Are results available for this study?
The study was stopped early (reason given: Closed by CHUM REB for incomplete documentation of research activities.). Results are not available in the source record.
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?
Difference in pain scores at 1 month and end of the trial (time frame: 1 month and 120 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02682082, which also lists 7 linked publications.
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 May 2020.