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

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EUS-guided celiac plexus neurolysis
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring EUS-guided CPN

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Changhai Hospital, Second Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ropivacaine

bupivacaine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 5, 2019
Last Updated
May 7, 2019
Sponsor
Changhai Hospital
Collaborators
Eastern Hepatobiliary Surgery Hospital, Shanghai Cancer Hospital, China, The Third Xiangya Hospital of Central South University, Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03940027
Brief Title
EUS-guided Celiac Plexus Neurolysis for the Treatment of Abdominal Pain in Pancreatic Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
Eastern Hepatobiliary Surgery Hospital, Shanghai Cancer Hospital, China, The Third Xiangya Hospital of Central South University, Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
EUS-guided CPN

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ropivacaine
Arm Type
Experimental
Arm Description
The patients will be carried on EUS-CPN with 10ml 0.75% ropivacaine with 10ml anhydrous alcohol
Arm Title
bupivacaine
Arm Type
Active Comparator
Arm Description
The patients will be carried on EUS-CPN with 10ml 0.75% bupivacaine with 10ml anhydrous alcohol
Intervention Type
Procedure
Intervention Name(s)
EUS-guided celiac plexus neurolysis
Intervention Description
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 Measure Information:
Title
The effective rate of abdominal pain relief
Description
Preoperative and postoperative pain scores of the patients will be compared to estimate the effective rate of abdominal pain relief.
Time Frame
2 weeks
Title
the incidence of serious complications
Description
Complications like perforation, infection, pancreatitis, hemorrhage and local anesthetic complications (epilepsy, arrhythmia), etc.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Improvement of quality of life
Description
Preoperative and postoperative quality of life questionnaire of the patients will be compared to estimate the improvement of quality of life
Time Frame
1 month, 3 months, 6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shi-yu Li, M.D.
Phone
+86-15521243639
Email
lizfish@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao-shen Li, Ph.D.
Organizational Affiliation
Changhai Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Changhai Hospital, Second Military Medical University
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhaoshen Li, MD
Phone
86-21-81873241
Email
zhaoshenlismmu@gmail.com
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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