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Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis

This study is currently recruiting participants.
Verified February 2013 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborators:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Erasme University Hospital
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01318590
First received: March 17, 2011
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatitis, Chronic
 Drug: Bupivacaine & Triamcinolone Acetonide
Other: No intervention except EUS procedure
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Pain reduction on Likert scale [ Time Frame: each month for six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life (QOL) score [ Time Frame: each month for six months ] [ Designated as safety issue: No ]
    the digestive disease QOL questionnaire 15 (DDQ-15) is used to analyze QOL


Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celiac bloc Drug: Bupivacaine & Triamcinolone Acetonide
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
Sham Comparator: Conservative treatment Other: No intervention except EUS procedure
EUS procedure without any drug injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318590

Contacts
Contact: Anand V Sahai, MD 1(514)8908000 ext 34373 anand.sahai@sympatico.ca
Contact: Mariana Usatii 1(514)8908000 m_usatii@yahoo.com

Locations
Belgium
Erasme Hospital Recruiting
Brussels, Belgium, B1070
Contact: Jacques Deviere, MD     +3225553712     jacques.deviere@erasme.ulb.ac.be    
Contact: Pierre Eisendrath, MD     +3225553712     pierreeisendrath@me.com    
Sub-Investigator: Pierre Eisendrath, MD            
Sub-Investigator: Jacques Deviere, MD            
Canada, Quebec
CHUM Recruiting
Montreal, Quebec, Canada
Contact: Anand V Sahai, MD     1(514)8908000 ext 34373     anand.sahai@sympatico.ca    
Principal Investigator: Anand V Sahai, MD            
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Erasme University Hospital
Investigators
Principal Investigator: Anand V Sahai, MD CHUM
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01318590     History of Changes
Other Study ID Numbers: CE 10 160
Study First Received: March 17, 2011
Last Updated: February 25, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Pancreatitis, Chronic
Abdominal Pain
Celiac bloc
Endosonography

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Bupivacaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013