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

NCT01318590 | Terminated Phase 3

• 1 other identifier: CE 10 160
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 2

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.

Conditions

Pancreatitis, Chronic

Keywords

Pancreatitis, Chronic; Abdominal Pain; Celiac bloc; Endosonography

Outcome Measures

Primary Outcomes (1)

• Pain reduction on Likert scale

  Pain scale with 7 levels

  each month for six months

Secondary Outcomes (1)

• Quality of Life (QOL) score

  each month for six months

Study Arms (2)

Celiac bloc

EXPERIMENTAL

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

Conservative treatment

SHAM COMPARATOR

Subject will undergo standard EUS without any additional interventions.

Other: EUS procedure

Interventions

EUS procedure with drug injection DRUG

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

Also known as: Bupivacaine & Triamcinolone Acetonide injection in the celiac plexus

Celiac bloc

EUS procedure OTHER

EUS procedure without any drug injection

Conservative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator
• Erasme University Hospital: collaborator

Study Sites (2)

Erasme Hospital

Brussels, B1070, Belgium

Location

CHUM

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Abdominal Pain

Interventions

Pharmaceutical Preparations; Bupivacaine; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Anand V Sahai, MD

  CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 18, 2011
• Study Start: November 18, 2011
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

BE (1); CA (1)