Pancreatic Cancer
Conditions
Keywords
EUS-guided CPN
Brief 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 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.
Interventions
PROCEDUREEUS-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.
Sponsors
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
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effective rate of abdominal pain relief | 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 | 2 weeks | Complications like perforation, infection, pancreatitis, hemorrhage and local anesthetic complications (epilepsy, arrhythmia), etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of quality of life | 1 month, 3 months, 6 months and 1 year | Preoperative and postoperative quality of life questionnaire of the patients will be compared to estimate the improvement of quality of life |
Countries
China
Contacts
Primary ContactShi-yu Li, M.D.
Outcome results
None listed