Pancreatic Cancer Clinical Trial
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
NCT number | NCT03940027 |
Other study ID # | CPN |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 10, 2019 |
Est. completion date | February 2021 |
Verified date | May 2019 |
Source | Changhai Hospital |
Contact | Shi-yu Li, M.D. |
Phone | +86-15521243639 |
lizfish[@]126.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | February 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital, Second Military Medical University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital | Eastern Hepatobiliary Surgery Hospital, Shanghai Cancer Hospital, China, The Third Xiangya Hospital of Central South University, Wuhan Union Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 weeks | |
Primary | the incidence of serious complications | Complications like perforation, infection, pancreatitis, hemorrhage and local anesthetic complications (epilepsy, arrhythmia), etc. | 2 weeks | |
Secondary | 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 | 1 month, 3 months, 6 months and 1 year |
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