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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03940027

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted May 9, 2019

Study Description

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.

  • Condition or Disease:Pancreatic Cancer
  • Intervention/Treatment: Procedure: EUS-guided celiac plexus neurolysis
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 120 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • 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
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: February 2021
Arms and interventions
Arm Intervention/treatment
Active Comparator: bupivacaine
The patients will be carried on EUS-CPN with 10ml 0.75% bupivacaine with 10ml anhydrous alcohol
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.
Experimental: ropivacaine
The patients will be carried on EUS-CPN with 10ml 0.75% ropivacaine with 10ml anhydrous alcohol
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.
Outcome Measures
  • Primary Outcome Measures: 1. The effective rate of abdominal pain relief [ Time Frame: 2 weeks ]
    Preoperative and postoperative pain scores of the patients will be compared to estimate the effective rate of abdominal pain relief.
  • 2. the incidence of serious complications [ Time Frame: 2 weeks ]
    Complications like perforation, infection, pancreatitis, hemorrhage and local anesthetic complications (epilepsy, arrhythmia), etc.
  • Secondary Outcome Measures: 1. Improvement of quality of life [ Time Frame: 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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 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.

Contacts and Locations
Contacts

Contact: Shi-yu Li, M.D. +86-15521243639 lizfish@126.com

Locations

China
Changhai Hospital, Second Military Medical University
Shanghai

Sponsors and Collaborators

Changhai Hospital

Eastern Hepatobiliary Surgery Hospital

Shanghai Cancer Hospital, China

The Third Xiangya Hospital of Central South University

Wuhan Union Hospital, China

Investigators

Study Chair: Zhao-shen Li, Ph.D. Changhai Hospital

More Information
  • Responsible Party: Changhai Hospital
  • ClinicalTrials.gov Identifier: NCT03940027 History of Changes
  • Other Study ID Numbers: CPN
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 9, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Changhai Hospital: EUS-guided CPN
  • Additional relevant MeSH terms: Pancreatic Neoplasms Abdominal Pain