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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03940027
• Other study ID #: CPN
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2019
• Est. completion date: February 2021

Study information

• Verified date: May 2019
• Source: Changhai Hospital
• Contact: Shi-yu Li, M.D.
• Phone: +86-15521243639
• Email: lizfish[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Abdominal Pain
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (5)

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

Country where clinical trial is conducted

China, 

Outcome

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