Clinical trial NCT03940027: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Keywords: EUS-guided CPN
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Eastern Hepatobiliary Surgery Hospital
name: Shanghai Cancer Hospital, China
name: The Third Xiangya Hospital of Central South University
name: Wuhan Union Hospital, China
First posted: 2019-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The effective rate of abdominal pain relief
timeFrame: 2 weeks
measure: the incidence of serious complications
timeFrame: 2 weeks
Secondary outcomes:
measure: Improvement of quality of life
timeFrame: 1 month, 3 months, 6 months and 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hospital
name: Zhao-shen Li, Ph.D.
role: STUDY_CHAIR
References: