Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis
Primary Purpose
Pancreatitis, Chronic
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EUS procedure with drug injection
EUS procedure
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatitis, Chronic focused on measuring Pancreatitis, Chronic, Abdominal Pain, Celiac bloc, Endosonography
Eligibility Criteria
Inclusion Criteria:
- abdominal pain compatible with pancreatic ethiology since at least 3 months
- chronic pancreatitis on Computed Tomography (CT), Endoscopic Retrograde Cholangiopancreatography (ERCP) or EUS
- EUS feasible
- inform consent
Exclusion Criteria:
- pregnant women
- allergy to local anesthetic
- acute pancreatitis in the last 2 weeks
- suspicious lesion on pancreatic EUS examination
- celiac bloc in the last 3 months
Sites / Locations
- Erasme Hospital
- CHUM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Celiac bloc
Conservative treatment
Arm Description
The experimental arm will consist of the fractional injection on both sides of the celiac trunk, via EUS, of a local anesthetic (10 ml of Bupivacaine 0.5% (gr / ml)) and an injection of steroids (Triamcinolone 40 mg). In this group antibiotic prophylaxis will be administered after administration of sedation (Cephazolin 1gr IV or Gentamycin).
Subject will undergo standard EUS without any additional interventions.
Outcomes
Primary Outcome Measures
Pain reduction on Likert scale
Pain scale with 7 levels
Secondary Outcome Measures
Quality of Life (QOL) score
the digestive disease QOL questionnaire 15 (DDQ-15) is used to analyze QOL
Full Information
NCT ID
NCT01318590
First Posted
March 17, 2011
Last Updated
May 12, 2020
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Erasme University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01318590
Brief Title
Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis
Official Title
Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Closed by CHUM REB for incomplete documentation of research activities.
Study Start Date
November 18, 2011 (Actual)
Primary Completion Date
June 14, 2019 (Actual)
Study Completion Date
June 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Erasme University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if celiac bloc (with injection of steroid and local anesthetic) is superior to a sham procedure for pain control and quality of life improvement in patient with chronic pancreatitis and abdominal pain.
Detailed Description
Chronic pancreatitis is a condition that can lead to very disabling pain symptoms that are difficult to control. The use of morphine is often necessary and also induces a series of secondary symptoms.
In this context, the injection into the celiac plexus block of a local anesthetic has often been proposed as an alternative. This procedure, by interrupting the afferent pain signal of pancreatic origin, aims to reduce pain and improve quality of life at the cost of fewer side effects.
This procedure can be performed transcutaneously using the anatomical landmark or under radiological control. It can also be performed via endosonography (EUS) with better control of the injection site under ultrasound control.
The results of the literature concerning the efficacy of the celiac block in chronic pancreatitis are rather encouraging with reported figures of partial or complete pain control in 39 to 65% of patients [1-7].
However, the number of prospective studies concerning this technique performed endoscopically remains low to date. In particular, there are no case control studies. Data is also poor on the impact on quality of life.
The study proposed here will therefore attempt to provide answers to the questions still pending: is the block by EUS superior to a diagnostic EUS without treatment? ; how long does this treatment last? ; does it have an impact on the quality of life of patients? This study and its draft are inspired by a similar recent study conducted in our department on patients with pancreatic neoplasia. The results of the latter are being submitted for publication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Chronic
Keywords
Pancreatitis, Chronic, Abdominal Pain, Celiac bloc, Endosonography
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Celiac bloc
Arm Type
Experimental
Arm Description
The experimental arm will consist of the fractional injection on both sides of the celiac trunk, via EUS, of a local anesthetic (10 ml of Bupivacaine 0.5% (gr / ml)) and an injection of steroids (Triamcinolone 40 mg). In this group antibiotic prophylaxis will be administered after administration of sedation (Cephazolin 1gr IV or Gentamycin).
Arm Title
Conservative treatment
Arm Type
Sham Comparator
Arm Description
Subject will undergo standard EUS without any additional interventions.
Intervention Type
Drug
Intervention Name(s)
EUS procedure with drug injection
Other Intervention Name(s)
Bupivacaine & Triamcinolone Acetonide injection in the celiac plexus
Intervention Description
EUS procedure with injection of 10 ml Bupivacaine 0.5% and 40 mg of Triamcinolone in the celiac plexus after administration of intravenous (IV) antibioprophylaxis
Intervention Type
Other
Intervention Name(s)
EUS procedure
Intervention Description
EUS procedure without any drug injection
Primary Outcome Measure Information:
Title
Pain reduction on Likert scale
Description
Pain scale with 7 levels
Time Frame
each month for six months
Secondary Outcome Measure Information:
Title
Quality of Life (QOL) score
Description
the digestive disease QOL questionnaire 15 (DDQ-15) is used to analyze QOL
Time Frame
each month for six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
abdominal pain compatible with pancreatic ethiology since at least 3 months
chronic pancreatitis on Computed Tomography (CT), Endoscopic Retrograde Cholangiopancreatography (ERCP) or EUS
EUS feasible
inform consent
Exclusion Criteria:
pregnant women
allergy to local anesthetic
acute pancreatitis in the last 2 weeks
suspicious lesion on pancreatic EUS examination
celiac bloc in the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand V Sahai, MD
Organizational Affiliation
CHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme Hospital
City
Brussels
ZIP/Postal Code
B1070
Country
Belgium
Facility Name
CHUM
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis
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