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

Not Applicable

• Conditions: Pancreatic Cancer
• Interventions: Procedure: EUS-guided celiac plexus neurolysis

• Registration Number: NCT03940027
• Lead Sponsor: Changhai Hospital

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 available

Study Timeline

• Study Start: 2019-02-10
• Status Verified: 2019-05
• Study First Submitted: 2019-05-05
• Study First Submitted QC: 2019-05-05
• Study First Posted: 2019-05-07
• Last Update Submitted: 2019-05-07
• Last Update Posted: 2019-05-09
• Primary Completion: 2020-12
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine	EUS-guided celiac plexus neurolysis	The patients will be carried on EUS-CPN with 10ml 0.75% bupivacaine with 10ml anhydrous alcohol
ropivacaine	EUS-guided celiac plexus neurolysis	The patients will be carried on EUS-CPN with 10ml 0.75% ropivacaine with 10ml anhydrous alcohol

Primary Outcome Measures

Name	Time	Method
the incidence of serious complications	2 weeks	Complications like perforation, infection, pancreatitis, hemorrhage and local anesthetic complications (epilepsy, arrhythmia), etc.
The effective rate of abdominal pain relief	2 weeks	Preoperative and postoperative pain scores of the patients will be compared to estimate the effective rate of abdominal pain relief.

Secondary Outcome Measures

Name	Time	Method
Improvement of quality of life	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

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China