Abdominal Pain, Pancreatitis, Chronic
Conditions
Brief summary
AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided celiac ganglia block (EUS-CGB) vs standard endoscopic ultrasound-guided celiac plexus block (EUS-CPB). METHODS: This is a single-center, double-blind, randomized parallel-group study to assess the efficacy of EUS-CPB vs. EUS-CGB in patients with painful chronic pancreatitis.
Detailed description
Inclusion criteria include: age\>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain. Exclusion criteria include: pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (\>1.5) or low platelet count (\<75 cells/mm3), allergy to eggs or caine anesthetics.
Interventions
PROCEDUREEUS-celiac ganglia block (EUS-CGB)
The intervention technique of EUS-CGB is the realization of EUS-guided celiac block with injection of bupivacaine directly into the ganglia for patients with chronic pancreatitis.
PROCEDUREEUS-celiac plexus block (EUS-CPB)
In the arm of EUS-CPB, the procedure is going to be performed with the standard EUS-guided celiac plexus block with injection of bupivacaine into the retroperitoneal space.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with chronic pancreatitis and referred for EUS-guided celiac plexus block with: age\>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain.
Exclusion criteria
* pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (\>1.5) or low platelet count (\<75 cells/mm3), allergy to eggs or caine anesthetics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief | 1 week | The primary endpoint will be pain relief at 1 week after the block, defined as a decrease of 3 or more points in the VAS scale measuring average pain over past week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | 1 week | Decrease in pain to 1 or 0. |
| Duration of pain relief | up to 2 months | Duration of pain relief will be assessed during a 2-month follow-up. |
| Opioid consumption | up to 2 months | Assess the opioid consumption in up to 2 months after endoscopic therapy. |
| Adverse effects | in up to 2 months | Assess the incidence of adverse effects after endoscopic therapy. |
Countries
United States
Outcome results
None listed