Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis
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|ClinicalTrials.gov Identifier: NCT01318590|
Recruitment Status : Terminated (Closed by CHUM REB for incomplete documentation of research activities.)
First Posted : March 18, 2011
Last Update Posted : May 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis, Chronic||Drug: EUS procedure with drug injection Other: EUS procedure||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis|
|Actual Study Start Date :||November 18, 2011|
|Actual Primary Completion Date :||June 14, 2019|
|Actual Study Completion Date :||June 14, 2019|
Experimental: Celiac bloc
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
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 Name: Bupivacaine & Triamcinolone Acetonide injection in the celiac plexus
Sham Comparator: Conservative treatment
Subject will undergo standard EUS without any additional interventions.
Other: EUS procedure
EUS procedure without any drug injection
- Pain reduction on Likert scale [ Time Frame: each month for six months ]Pain scale with 7 levels
- Quality of Life (QOL) score [ Time Frame: each month for six months ]the digestive disease QOL questionnaire 15 (DDQ-15) is used to analyze QOL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318590
|Brussels, Belgium, B1070|
|Montreal, Quebec, Canada|
|Principal Investigator:||Anand V Sahai, MD||CHUM|