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

NCT03940027 | Unknown

• 1 other identifier: CPN
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

EUS-guided CPN

Outcome Measures

Primary Outcomes (2)

• 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

• the incidence of serious complications

  Complications like perforation, infection, pancreatitis, hemorrhage and local anesthetic complications (epilepsy, arrhythmia), etc.

  2 weeks

Secondary Outcomes (1)

• Improvement of quality of life

  1 month, 3 months, 6 months and 1 year

Study Arms (2)

ropivacaine

EXPERIMENTAL

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

Procedure: EUS-guided celiac plexus neurolysis

bupivacaine

ACTIVE COMPARATOR

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

Procedure: EUS-guided celiac plexus neurolysis

Interventions

EUS-guided celiac plexus neurolysis PROCEDURE

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.

bupivacaine; ropivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Eastern Hepatobiliary Surgery Hospital: collaborator
• Shanghai Cancer Hospital, China: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Zhao-shen Li, Ph.D.

  Changhai Hospital

  STUDY CHAIR

Central Study Contacts

Shi-yu Li, M.D.

CONTACT

+86-15521243639; lizfish@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of the Gastroenterology

Model Details: 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

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 7, 2019
• Study Start: February 10, 2019
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)