免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / EUS-guided Celiac Plexus Neurolysis for the Treatment of Abdominal Pain in Pancreatic Cancer

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

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

Study Design
Layout table for study information
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
Arms and Interventions
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.
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
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Shi-yu Li, M.D. +86-15521243639 lizfish@126.com

Locations
Layout table for location information
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
Layout table for investigator information
Study Chair: Zhao-shen Li, Ph.D. Changhai Hospital
Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE February 10, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
  • 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.
  • the incidence of serious complications [ Time Frame: 2 weeks ]
    Complications like perforation, infection, pancreatitis, hemorrhage and local anesthetic complications (epilepsy, arrhythmia), etc.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2019) 		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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EUS-guided Celiac Plexus Neurolysis for the Treatment of Abdominal Pain in Pancreatic Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: ropivacaine
    The patients will be carried on EUS-CPN with 10ml 0.75% ropivacaine with 10ml anhydrous alcohol
    Intervention: Procedure: EUS-guided celiac plexus neurolysis
  • Active Comparator: bupivacaine
    The patients will be carried on EUS-CPN with 10ml 0.75% bupivacaine with 10ml anhydrous alcohol
    Intervention: Procedure: EUS-guided celiac plexus neurolysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 5, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940027
Other Study ID Numbers  ICMJE CPN
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhaoshen Li, Changhai Hospital
Study Sponsor  ICMJE Changhai Hospital
Collaborators  ICMJE
  • Eastern Hepatobiliary Surgery Hospital
  • Shanghai Cancer Hospital, China
  • The Third Xiangya Hospital of Central South University
  • Wuhan Union Hospital, China
Investigators  ICMJE
Study Chair: Zhao-shen Li, Ph.D. Changhai Hospital
PRS Account Changhai Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯