Back to resultsClinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis
Primary Purpose
Pancreatitis, Chronic, Abdominal Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EUS-celiac ganglia block (EUS-CGB)
EUS-celiac plexus block (EUS-CPB)
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatitis, Chronic
Eligibility Criteria
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.
Sites / Locations
- Cleveland Clinic Main Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
EUS-celiac plexus block (EUS-CPB)
EUS-celiac ganglia block (EUS-CGB)
Arm Description
This is the standard technique. In this approach, the needle is passed through the body of the stomach adjacent the celiac artery into the retroperitoneal space in 1 or 2 passes. The injectate (bupivacaine or alcohol) is injected and spreads through the retroperitoneal space, effectively "bathing" all the ganglia.
This is a more recent technique which has been often used. In this procedure, the needle is inserted under EUS guidance directly into as many ganglia as possible. For celiac ganglia <1cm in diameter, the solution is injected into the central point; for those ≥1 cm, a needle is advanced to the deepest point into the ganglia and solution is injected as the needle is slowly withdrawn. Injections are continued until an echogenic pattern is produced over the entire celiac ganglia.
Outcomes
Primary Outcome Measures
Pain relief
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 Outcome Measures
Complete response rate
Decrease in pain to 1 or 0.
Duration of pain relief
Duration of pain relief will be assessed during a 2-month follow-up.
Opioid consumption
Assess the opioid consumption in up to 2 months after endoscopic therapy.
Adverse effects
Assess the incidence of adverse effects after endoscopic therapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03070210
Brief Title
Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis
Official Title
A Randomized, Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Blockade (EUS-CPB) With Standard Plexus Injection vs. Direct Celiac Ganglia Block for Treatment of Pain in Chronic Pancreatitis.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Chronic, Abdominal Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EUS-celiac plexus block (EUS-CPB)
Arm Type
Other
Arm Description
This is the standard technique. In this approach, the needle is passed through the body of the stomach adjacent the celiac artery into the retroperitoneal space in 1 or 2 passes. The injectate (bupivacaine or alcohol) is injected and spreads through the retroperitoneal space, effectively "bathing" all the ganglia.
Arm Title
EUS-celiac ganglia block (EUS-CGB)
Arm Type
Active Comparator
Arm Description
This is a more recent technique which has been often used. In this procedure, the needle is inserted under EUS guidance directly into as many ganglia as possible. For celiac ganglia <1cm in diameter, the solution is injected into the central point; for those ≥1 cm, a needle is advanced to the deepest point into the ganglia and solution is injected as the needle is slowly withdrawn. Injections are continued until an echogenic pattern is produced over the entire celiac ganglia.
Intervention Type
Procedure
Intervention Name(s)
EUS-celiac ganglia block (EUS-CGB)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
EUS-celiac plexus block (EUS-CPB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain relief
Description
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".
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Complete response rate
Description
Decrease in pain to 1 or 0.
Time Frame
1 week
Title
Duration of pain relief
Description
Duration of pain relief will be assessed during a 2-month follow-up.
Time Frame
up to 2 months
Title
Opioid consumption
Description
Assess the opioid consumption in up to 2 months after endoscopic therapy.
Time Frame
up to 2 months
Title
Adverse effects
Description
Assess the incidence of adverse effects after endoscopic therapy.
Time Frame
in up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyler Stevens, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Cleveland Clinic Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23616126
Citation
Doi S, Yasuda I, Kawakami H, Hayashi T, Hisai H, Irisawa A, Mukai T, Katanuma A, Kubota K, Ohnishi T, Ryozawa S, Hara K, Itoi T, Hanada K, Yamao K. Endoscopic ultrasound-guided celiac ganglia neurolysis vs. celiac plexus neurolysis: a randomized multicenter trial. Endoscopy. 2013;45(5):362-9. doi: 10.1055/s-0032-1326225. Epub 2013 Apr 24.
Results Reference
background
PubMed Identifier
21295640
Citation
Ascunce G, Ribeiro A, Reis I, Rocha-Lima C, Sleeman D, Merchan J, Levi J. EUS visualization and direct celiac ganglia neurolysis predicts better pain relief in patients with pancreatic malignancy (with video). Gastrointest Endosc. 2011 Feb;73(2):267-74. doi: 10.1016/j.gie.2010.10.029.
Results Reference
background
Learn more about this trial
Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis
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