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

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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

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Pain reduction on Likert scale

Secondary Outcome

 Quality of Life (QOL) score

Condition

Pancreatitis, Chronic

Intervention

EUS procedure with drug injection

Study Arms / Comparison Groups

 Celiac bloc
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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

2

Start Date

November 18, 2011

Completion Date

June 14, 2019

Primary Completion Date

June 14, 2019

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anand V Sahai, MD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT01318590

Organization ID

CE 10 160


Responsible Party

Principal Investigator

Study Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

 Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Study Sponsor

Anand V Sahai, MD, Principal Investigator, CHUM


Verification Date

May 2020