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Trial record 1 of 35 for:    Recruiting, Not yet recruiting, Available Studies | "Pancreatitis, Chronic"
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Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 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: August 3, 2016
Last verified: July 2016
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:


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 ]

Secondary Outcome Measures:
  • Quality of Life (QOL) score [ Time Frame: each month for six months ]
    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 2017
Estimated Primary Completion Date: June 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: August 3, 2016

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

Additional relevant MeSH terms:
Pancreatitis, Chronic
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Bupivacaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
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 June 27, 2017