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

Naval Military Medical University

Status: Unknown

Conditions: Pancreatic Cancer

Treatments: Procedure: EUS-guided celiac plexus neurolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03940027

CPN

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

ropivacaine

Experimental group

Description:

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

Treatment:

Procedure: EUS-guided celiac plexus neurolysis

bupivacaine

Active Comparator group

Description:

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

Treatment:

Procedure: EUS-guided celiac plexus neurolysis