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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)

Tracking Information
First Submitted Date  ICMJE March 17, 2011
First Posted Date  ICMJE March 18, 2011
Last Update Posted Date May 13, 2020
Actual Study Start Date  ICMJE November 18, 2011
Actual Primary Completion Date June 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
Pain reduction on Likert scale [ Time Frame: each month for six months ]
Pain scale with 7 levels
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2011)
Pain reduction on Likert scale [ Time Frame: each month for six months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2011)
QOL DDQ15 [ Time Frame: each month for six months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Pancreatitis, Chronic
Intervention  ICMJE
  • 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
  • Other: EUS procedure
    EUS procedure without any drug injection
Study Arms  ICMJE
  • 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).
    Intervention: Drug: EUS procedure with drug injection
  • Sham Comparator: Conservative treatment
    Subject will undergo standard EUS without any additional interventions.
    Intervention: Other: EUS procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 12, 2020)
2
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2011)
100
Actual Study Completion Date  ICMJE June 14, 2019
Actual Primary Completion Date June 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01318590
Other Study ID Numbers  ICMJE CE 10 160
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party A Sahai, Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor  ICMJE Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators  ICMJE
  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal
  • Erasme University Hospital
Investigators  ICMJE
Principal Investigator: Anand V Sahai, MD CHUM
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP