EUS-guided Celiac Plexus Neurolysis for the Treatment of Abdominal Pain in Pancreatic Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Aged between 18-75; 2. Athologically confirmed as pancreatic cancer and clinically evaluated as advanced and unresectable; 3. The visual analogue scale (VAS) for pain ≥ 4; 4. Never received treatment for peritoneal plexus lesion or block; 5. Voluntary signing of written informed consent

Exclusion Criteria:

1. Women during pregnancy; 2. Cannot or refuses to sign the informed consent; 3. Blood clotting disorder(PLT <50 × 103/μL, INR > 1.5); 4. Celiac infection; 5. Severe esophageal or gastric varices and ulcers which may affect operation; 6. The anatomical variation of the abdominal trunk abdominal aorta and could not be accurately located; 7. Alcohol allergy 8. Severe cardiopulmonary dysfunction and inability to tolerate the risk of intravenous anesthesia; 9. History of mental illness; 10. Patients with other chronic and acute diseases with unstable conditions that are expected to affect the efficacy evaluation and completion of the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03940027
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Changhai Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Zhao-shen Li, Ph.D.
Principal Investigator Affiliation Changhai Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherOther
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pancreatic Cancer
Arms & Interventions

Arms

Experimental: ropivacaine

The patients will be carried on EUS-CPN with 10ml 0.75% ropivacaine with 10ml anhydrous alcohol

Active Comparator: bupivacaine

The patients will be carried on EUS-CPN with 10ml 0.75% bupivacaine with 10ml anhydrous alcohol

Interventions

Procedure: - EUS-guided celiac plexus neurolysis

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shanghai, China

Status

Recruiting

Address

Changhai Hospital, Second Military Medical University

Shanghai, , 200433

Site Contact

zhaoshen Li, MD

zhaoshenlismmu@gmail.com

86-21-81873241

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