Clinical trial NCT01318590: Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis
Official title: Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pancreatitis, Chronic
Keywords: Pancreatitis, Chronic
Abdominal Pain
Celiac bloc
Endosonography
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Erasme University Hospital
First posted: 2011-03-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Pain reduction on Likert scale
timeFrame: each month for six months
Secondary outcomes:
measure: Quality of Life (QOL) score
timeFrame: each month for six months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
city: Montreal
country: Canada
facility: CHUM
state: Quebec
Study officials:
affiliation: CHUM
name: Anand V Sahai, MD
role: PRINCIPAL_INVESTIGATOR
References: