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

Pancreatitis, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01318590
• Other study ID #: CE 10 160
• Status: Terminated
• Phase: Phase 3
• Start date: November 18, 2011
• Est. completion date: June 14, 2019

Study information

• Verified date: May 2020
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Chronic

Intervention

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:
• EUS procedure
EUS procedure without any drug injection

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels
Canada	CHUM	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Erasme University Hospital

Countries where clinical trial is conducted

Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction on Likert scale	Pain scale with 7 levels	each month for six months
Secondary	Quality of Life (QOL) score	the digestive disease QOL questionnaire 15 (DDQ-15) is used to analyze QOL	each month for six months