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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01318590
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre hospitalier de l'Université de Montréal (CHUM)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Anand V Sahai, MD
Principal Investigator Affiliation CHUM
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Belgium, Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pancreatitis, Chronic

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Erasme Hospital, Brussels, Belgium

Status

Recruiting

Address

Erasme Hospital

Brussels, , B1070

Site Contact

Jacques Deviere, MD

jacques.deviere@erasme.ulb.ac.be

+3225553712

CHUM, Montreal, Quebec, Canada

Status

Recruiting

Address

CHUM

Montreal, Quebec,

Site Contact

Anand V Sahai, MD

anand.sahai@sympatico.ca

1(514)8908000 #34373

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