Efficacy of EUS-Guided Celiac Plexus Blockade in Chronic Pancreatitis



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:7/16/2013
Start Date:March 2008
Contact:Adele Costanza
Phone:216-445-3851

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A RANDOMIZED, TRIPLE-BLINDED STUDY OF ENDOSCOPIC ULTRASOUND GUIDED CELIAC PLEXUS BLOCKADE (EUS-CPB) WITH BUPIVICAINE AND TRIAMCINOLONE VS. BUPIVICAINE ALONE FOR TREATMENT OF PAIN IN CHRONIC PANCREATITIS


This is a triple-blind, parallel group, randomized controlled trial to assess the benefit of
triamcinolone injection as a therapeutic measure for control of chronic pancreatitis pain.
The treatment group will undergo EUS-CPB with bupivicaine plus triamcinolone ("therapeutic
block"). There control group will undergo EUS-CPB with bupivicaine alone ("diagnostic
block").


There are few effective options for the treatment of abdominal pain in chronic pancreatitis.
For the past 20 years, percutaneous injection of anesthetic agents into the celiac plexus
(celiac plexus blockade or CPB) has been performed by pain anesthesiologists to diagnose the
origin of pancreatic pain (visceral vs. non-visceral). Anesthetic blocks provide very
short-term and variable pain relief. More recently, endoscopic ultrasound has been used to
provide a transgastric approach to the celiac plexus (EUS-CPB).

Corticosteroids may lengthen the effect of CPB to provide longer-lasting pain relief
("therapeutic block"). Case-series report that about 50% of patients experience partial or
complete relief lasting an average of 1-2 months. Combined corticosteroid (triamcinolone)
and anesthetic (bupivicaine) has now become standard practice for EUS-CPB. However, there
have been no randomized controlled trials to prove that corticosteroid blocks are truly
therapeutic (i.e. that they lengthen the effect of the typical "diagnostic" CPB with
anesthetics). Randomized controlled trials are needed to demonstrate the therapeutic
efficacy of CPB with corticosteroids.

This is a triple-blind, parallel group, randomized controlled trial to assess the benefit of
triamcinolone injection as a therapeutic measure for control of chronic pancreatitis pain.
The treatment group will undergo EUS-CPB with bupivicaine plus triamcinolone ("therapeutic
block"). There control group will undergo EUS-CPB with bupivicaine alone ("diagnostic
block").

Eligible patients with abdominal pain undergoing EUS for the diagnosis of chronic
pancreatitis or EUS-CPB for pancreatic pain will be recruited. Patients will complete a
2-week run-in period to establish baseline pain scores and opioid consumption. Following the
run-in, EUS will be performed. If EUS reveals CP (>4 criteria), patients will be randomized
to one of the two treatment groups. 74 patients will be randomized and followed for 2 months
after the EUS-CPB. The primary endpoint is an improvement in the pain disability index (PDI)
of greater than 10 points at 1 month. Secondary endpoints include opioid consumption,
duration of pain relief, and quality of life (SF-12).

If this trial shows that the addition of triamcinolone produces a long-lasting (1-month)
benefit, then EUS-CPB can be more strongly advocated as a therapeutic option to patients
with chronic pancreatitis. If triamcinolone does not produce a benefit over a diagnostic
block, then EUS-CPB should be considered a primarily diagnostic measure for differentiation
of visceral from non-visceral pain.

Inclusion criteria include:

- Age >18 yrs

- Ability for informed consent

- Chronic pancreatic-type abdominal pain (type B) (11).

Exclusion criteria include:

- Pregnancy

- Malignancy

- Recent acute pancreatitis (within 2 months)

- Elevated INR (>1.5) or low platelet count (<75 cells/mm3)

- Allergy to eggs or "caine" anesthetics or corticosteroids; AND

- Becks depression score>20.
We found this trial at
1
site
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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from
Cleveland, OH
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