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

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ClinicalTrials.gov Identifier: NCT03940027
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborators:
Eastern Hepatobiliary Surgery Hospital
Shanghai Cancer Hospital, China
The Third Xiangya Hospital of Central South University
Wuhan Union Hospital, China
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

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 Intervention/treatment Phase
Pancreatic Cancer Procedure: EUS-guided celiac plexus neurolysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 10, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
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.

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.




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



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Ages Eligible for Study:   18 Years 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 <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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940027


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

Locations
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China
Changhai Hospital, Second Military Medical University Recruiting
Shanghai, China, 200433
Contact: zhaoshen Li, MD    86-21-81873241    zhaoshenlismmu@gmail.com   
Principal Investigator: Zhaoshen Li, MD         
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
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Study Chair: Zhao-shen Li, Ph.D. Changhai Hospital

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Responsible Party: Zhaoshen Li, chief of the Gastroenterology, 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhaoshen Li, Changhai Hospital:
EUS-guided CPN

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Abdominal Pain
Digestive System Diseases
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents