- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03940027
EUS-guided Celiac Plexus Neurolysis for the Treatment of Abdominal Pain in Pancreatic Cancer
May 7, 2019 updated by: Zhaoshen Li, Changhai Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
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 Contact
- Name: Shi-yu Li, M.D.
- Phone Number: +86-15521243639
- Email: lizfish@126.com
Study Locations
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Shanghai, China, 200433
- Recruiting
- Changhai Hospital, Second Military Medical University
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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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ropivacaine
The patients will be carried on EUS-CPN with 10ml 0.75% ropivacaine with 10ml anhydrous alcohol
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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.
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Active Comparator: bupivacaine
The patients will be carried on EUS-CPN with 10ml 0.75% bupivacaine with 10ml anhydrous alcohol
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effective rate of abdominal pain relief
Time Frame: 2 weeks
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Preoperative and postoperative pain scores of the patients will be compared to estimate the effective rate of abdominal pain relief.
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2 weeks
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the incidence of serious complications
Time Frame: 2 weeks
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Complications like perforation, infection, pancreatitis, hemorrhage and local anesthetic complications (epilepsy, arrhythmia), etc.
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of quality of life
Time Frame: 1 month, 3 months, 6 months and 1 year
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Preoperative and postoperative quality of life questionnaire of the patients will be compared to estimate the improvement of quality of life
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1 month, 3 months, 6 months and 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Zhao-shen Li, Ph.D., Changhai Hospital
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)
February 10, 2019
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
February 1, 2021
Study Registration Dates
First Submitted
May 5, 2019
First Submitted That Met QC Criteria
May 5, 2019
First Posted (Actual)
May 7, 2019
Study Record Updates
Last Update Posted (Actual)
May 9, 2019
Last Update Submitted That Met QC Criteria
May 7, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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Fudan UniversityUnknownStage ⅠA Pancreatic Cancer | Stage ⅠB Pancreatic Cancer | Stage ⅡA Pancreatic Cancer | Stage ⅡB Pancreatic CancerChina
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University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
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Asian Institute of Gastroenterology, IndiaUnknown
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University of Alabama at BirminghamAdventHealthCompletedPain | Pancreatic CancerUnited States
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Centre hospitalier de l'Université de Montréal...CompletedInoperable, Painful Pancreatic CancerCanada
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Northwestern UniversityWithdrawn
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Chinese University of Hong KongRecruitingPancreatic Cancer Non-resectable | Pain Cancer | Tumor PancreasHong Kong
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Indiana UniversityRecruitingChronic PancreatitisUnited States
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National Institute of Diabetes and Digestive and...Completed
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Mansoura UniversityCompleted
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Chinese University of Hong KongTerminatedIntractable Abdominal Pain Secondary to Inoperable MalignancyChina
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Orlando Health, Inc.RecruitingChronic PancreatitisUnited States