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

Phase 3

Terminated

• Conditions: Pancreatitis, Chronic
• Interventions: Drug: EUS procedure with drug injection; Other: EUS procedure

• Registration Number: NCT01318590
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-18
• Study Start: 2011-11-18
• Primary Completion: 2019-06-14
• Study Completion: 2019-06-14
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celiac bloc	EUS procedure with drug injection	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).
Conservative treatment	EUS procedure	Subject will undergo standard EUS without any additional interventions.

Primary Outcome Measures

Name	Time	Method
Pain reduction on Likert scale	each month for six months	Pain scale with 7 levels

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QOL) score	each month for six months	the digestive disease QOL questionnaire 15 (DDQ-15) is used to analyze QOL

Trial Locations

Locations (2)

Erasme Hospital; 🇧🇪 Brussels, Belgium

CHUM; 🇨🇦 Montreal, Quebec, Canada