EUS-guided Celiac Plexus Neurolysis For The Treatment Of Abdominal Pain In Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

PROCEDURE: EUS-guided celiac plexus neurolysis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-05-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-05-07
First Submitted that Met QC Criteria 2019-05-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-05-09
First Posted (ACTUAL) 2019-05-07	Results First Posted N/A	Last Verified 2019-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/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 n
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 n

Participant Group/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 n

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 n

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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	1 month, 3 months, 6 months and 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Shi-yu Li, M.D.

Phone Number: +86-15521243639

Email: lizfish@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record