Pancreatic CancerNCT03940027
EUS-guided Celiac Plexus Neurolysis for the Treatment of Abdominal Pain in Pancreatic Cancer
A study testing EUS-guided celiac plexus neurolysis in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
Studies have shown that injecting local anesthetics in areas rich in blood vessels increases the risk of drug injection into blood vessels by mistake and increases the systemic absorption of drugs, which may increase the incidence of central nervous system and cardiovascular system toxic events caused by local… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- 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
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2019to Feb 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-75;
- Athologically confirmed as pancreatic cancer and clinically evaluated as advanced and unresectable;
- The visual analogue scale (VAS) for pain ≥ 4；
- Never received treatment for peritoneal plexus lesion or block；
- Voluntary signing of written informed consent
Who cannot join
- Women during pregnancy；
- Cannot or refuses to sign the informed consent；
- Blood clotting disorder（PLT <50 × 103/μL, INR > 1.5）；
- Celiac infection；
- Severe esophageal or gastric varices and ulcers which may affect operation;
- The anatomical variation of the abdominal trunk abdominal aorta and could not be accurately located;
Show all 10Show fewer
- Alcohol allergy
- Severe cardiopulmonary dysfunction and inability to tolerate the risk of intravenous anesthesia;
- History of mental illness;
- Patients with other chronic and acute diseases with unstable conditions that are expected to affect the efficacy evaluation and completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Second Military Medical University
Shanghai, 200433
zhaoshen Li, MD, 86-21-81873241, zhaoshenlismmu@gmail.com
Zhaoshen Li, MD
About this study
Official title: EUS-guided Celiac Plexus Neurolysis Using Ropivacaine Combined With Anhydrous Alcohol for the Treatment of Abdominal Pain in Pancreatic Cancer: a Prospective Multicenter Randomized Clinical Trial
Studies have shown that injecting local anesthetics in areas rich in blood vessels increases the risk of drug injection into blood vessels by mistake and increases the systemic absorption of drugs, which may increase the incidence of central nervous system and cardiovascular system toxic events caused by local anesthetics.EUS-CPN-related complications have not been clearly associated with local anesthetic adverse events.However, EUS-CPN local anesthetic injection area is located around the beginning of the abdominal trunk with abundant large and small blood vessels. The choice of local anesthetics with higher safety than bupivacaine, such as ropivacaine, is of great significance to ensure the safety of eus-cpn, especially for eus-cpn beginners.At present, there are no reports on the application of ropivacaine in eus-cpn.
- Conditions
- Pancreatic Cancer
- Being tested
- EUS-guided celiac plexus neurolysis
- Keywords
- EUS-guided CPN
- 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
EUS-guided celiac plexus neurolysis (EUE-CPN) is an endoscopic ultrasound-guided injection of local anesthetics and neurodegenerative agents into the abdominal ganglion area through the gastric wall, so as to achieve irreversible damage of the abdominal nerve and interrupt the pain pathway of pancreatic cancer.EUS-CPN has the advantages of less trauma, higher technical success rate and lower risk of complications compared with traditional ct-guided CPN in vitro puncture.The data showed that eus-cpn was effective in the treatment of pancreatic cancer related persistent abdominal pain up to about 70%, significantly reducing the dosage of analgesics and improving the quality of life of patients with advanced pancreatic cancer.
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine | Experimental | The patients will be carried on EUS-CPN with 10ml 0.75% ropivacaine with 10ml anhydrous alcohol Receives: Procedure: EUS-guided celiac plexus neurolysis |
| bupivacaine | Active comparator | The patients will be carried on EUS-CPN with 10ml 0.75% bupivacaine with 10ml anhydrous alcohol Receives: Procedure: EUS-guided celiac plexus neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effective rate of abdominal pain relief
Preoperative and postoperative pain scores of the patients will be compared to estimate the effective rate of abdominal pain relief.
Measured: 2 weeks
the incidence of serious complications
Complications like perforation, infection, pancreatitis, hemorrhage and local anesthetic complications (epilepsy, arrhythmia), etc.
Measured: 2 weeks
Secondary outcomes (1)
Improvement of quality of life
Preoperative and postoperative quality of life questionnaire of the patients will be compared to estimate the improvement of quality of life
Measured: 1 month, 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start10 Feb 2019
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The included patients were divided into two groups (stage III and stage IV) according to tumor staging, and the patients in the two groups were randomly divided into two groups for EUS-CPN treatment with ropivacaine + anhydrous alcohol regimen and bupivacaine + anhydrous alcohol regimen
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, Shanghai Cancer Hospital, China, The Third Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhao-shen Li, Ph.D., Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940027
- Sponsor's protocol ID
- CPN
- Status last verified
- May 2019
- First submitted
- 5 May 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Celiac Plexus Neurolysis Using Ropivacaine Combined With Anhydrous Alcohol for the Treatment of Abdominal Pain in Pancreatic Cancer: a Prospective Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03940027
- Acronym / sponsor ID
- CPN
- Conditions
- Pancreatic Cancer
- Keywords
- EUS-guided CPN
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, Shanghai Cancer Hospital, China, The Third Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 7 May 2019 (actual)
- 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.
Studies have shown that injecting local anesthetics in areas rich in blood vessels increases the risk of drug injection into blood vessels by mistake and increases the systemic absorption of drugs, which may increase the incidence of central nervous system and cardiovascular system toxic events caused by local anesthetics.EUS-CPN-related complications have not been clearly associated with local anesthetic adverse events.However, EUS-CPN local anesthetic injection area is located around the beginning of the abdominal trunk with abundant large and small blood vessels. The choice of local anesthetics with higher safety than bupivacaine, such as ropivacaine, is of great significance to ensure the safety of eus-cpn, especially for eus-cpn beginners.At present, there are no reports on the application of ropivacaine in eus-cpn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The included patients were divided into two groups (stage III and stage IV) according to tumor staging, and the patients in the two groups were randomly divided into two groups for EUS-CPN treatment with ropivacaine + anhydrous alcohol regimen and bupivacaine + anhydrous alcohol regimen
| Arm | Type | Receives |
|---|---|---|
| ropivacaine | Experimental | Procedure: EUS-guided celiac plexus neurolysisThe patients will be carried on EUS-CPN with 10ml 0.75% ropivacaine with 10ml anhydrous alcohol |
| bupivacaine | Active comparator | Procedure: EUS-guided celiac plexus neurolysisThe patients will be carried on EUS-CPN with 10ml 0.75% bupivacaine with 10ml anhydrous alcohol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18-75;
- Athologically confirmed as pancreatic cancer and clinically evaluated as advanced and unresectable;
- The visual analogue scale (VAS) for pain ≥ 4；
- Never received treatment for peritoneal plexus lesion or block；
- Voluntary signing of written informed consent
Key exclusion criteria (10 listed)
- Women during pregnancy；
- Cannot or refuses to sign the informed consent；
- Blood clotting disorder（PLT <50 × 103/μL, INR > 1.5）；
- Celiac infection；
- Severe esophageal or gastric varices and ulcers which may affect operation;
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 neurolysisEUS-guided celiac plexus neurolysis (EUE-CPN) is an endoscopic ultrasound-guided injection of local anesthetics and neurodegenerative agents into the abdominal ganglion area through the gastric wall, so as to achieve irreversible damage of the abdominal nerve and interrupt the pain pathway of pancreatic cancer.EUS-CPN has the advantages of less trauma, higher technical success rate and lower risk of complications compared with traditional ct-guided CPN in vitro puncture.The data showed that eus-cpn was effective in the treatment of pancreatic cancer related persistent abdominal pain up to about 70%, significantly reducing the dosage of analgesics and improving the quality of life of patients with advanced pancreatic cancer. | Procedure or surgery | bupivacaine, ropivacaine |
Primary outcome
The effective rate of abdominal pain relief
Time frame: 2 weeks
Preoperative and postoperative pain scores of the patients will be compared to estimate the effective rate of abdominal pain relief.
the incidence of serious complications
Time frame: 2 weeks
Complications like perforation, infection, pancreatitis, hemorrhage and local anesthetic complications (epilepsy, arrhythmia), etc.
1 secondary outcome
Improvement of quality of life
Time frame: 1 month, 3 months, 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Zhao-shen Li, Ph.D. study chair
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided celiac plexus neurolysis in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 May 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shi-yu Li, M.D. (+86-15521243639, lizfish@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effective rate of abdominal pain relief (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 9 May 2019.