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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01318590
Recruitment Status : Terminated (Closed by CHUM REB for incomplete documentation of research activities.)
First Posted : March 18, 2011
Last Update Posted : May 13, 2020
Sponsor:
Collaborators:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Erasme University Hospital
Information provided by (Responsible Party):
A Sahai, Centre hospitalier de l'Université de Montréal (CHUM)

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.

Condition or disease Intervention/treatment Phase
Pancreatitis, Chronic Drug: EUS procedure with drug injection Other: EUS procedure Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis
Actual Study Start Date : November 18, 2011
Actual Primary Completion Date : June 14, 2019
Actual Study Completion Date : June 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Celiac bloc
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).
Drug: EUS procedure with drug injection
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
Other Name: Bupivacaine & Triamcinolone Acetonide injection in the celiac plexus

Sham Comparator: Conservative treatment
Subject will undergo standard EUS without any additional interventions.
Other: EUS procedure
EUS procedure without any drug injection




Primary Outcome Measures :
  1. Pain reduction on Likert scale [ Time Frame: each month for six months ]
    Pain scale with 7 levels


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318590


Locations
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Belgium
Erasme Hospital
Brussels, Belgium, B1070
Canada, Quebec
CHUM
Montreal, Quebec, Canada
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
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Principal Investigator: Anand V Sahai, MD CHUM
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Responsible Party: A Sahai, Gastroenterologist, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01318590    
Other Study ID Numbers: CE 10 160
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by A Sahai, Centre hospitalier de l'Université de Montréal (CHUM):
Pancreatitis, Chronic
Abdominal Pain
Celiac bloc
Endosonography
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Bupivacaine
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