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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01318590

Enrollment

Registered

2011-03-18

Start date

2011-11-18

Completion date

2019-06-14

Last updated

2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatitis, Chronic

Keywords

Pancreatitis, Chronic, Abdominal Pain, Celiac bloc, Endosonography

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.

Interventions

DRUGEUS 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

OTHEREUS procedure

EUS procedure without any drug injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain reduction on Likert scale	each month for six months	Pain scale with 7 levels

Secondary

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

Countries

Belgium, Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026