Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00658736
• Collaborator: American Society for Gastrointestinal Endoscopy (Other), TAP Pharmaceutical Products Inc. (Industry)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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").

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis	Drug: Triamcinolone; Drug: Bupivicaine alone	Phase 3

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Triple-Blinded Study of Endoscopic Ultrasound Guided Celiac Plexus Blockade (EUS-CPB) With Bupivicaine and Triamcinolone vs. Bupivicaine Alone for the Treatment of Pain in Chronic Pancreatitis
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 EUS guided celiac block with bupivicaine and triamcinolone. Patient will undergo endoscopic ultrasound and celiac plexus blockade using an EUS needle inserted into the celiac plexus. 20 cc of injectate will be administered.	Drug: Triamcinolone; Injection of bupivacaine and triamcinolone
Placebo Comparator: 2 EUS guided celiac block with bupivicaine only. Patient will undergo endoscopic ultrasound and celiac plexus blockade using an EUS needle inserted into the celiac plexus. 20 cc of injectate will be administered.	Drug: Bupivicaine alone; Injection of bupivacaine

Outcome Measures

Primary Outcome Measures

1. Change in Pain Disability Index [1 month after block]

   The Pain Disability Index (PDI) measures patients' responses of the extent to which pain limits their abilities to carry out everyday tasks. The index is scored from 0 (no limitation) to 70 (severe limitation). A decrease in score of 10 points or more is regarded as indicating significant improvement in the ability to carry out daily activities.

Secondary Outcome Measures

1. Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component [1 month]

   The SF12 survey measures patients' impressions of their level of health and well-being. The results are reported as two scores: A physical component and a mental component, each of which is reported on a scale of 0 (lowest level of health) to 100 (excellent health). Scores that increase from baseline indicate an improvement in patients' feelings of well-being.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic
• American Society for Gastrointestinal Endoscopy
• TAP Pharmaceutical Products Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tyler Stevens, MD, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00658736
• Other Study ID Numbers: CCF IRB 07-729
• First Posted: Apr 15, 2008
• Last Update Posted: Jun 14, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic; Triamcinolone; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Bupivicaine Alone	Bupivicaine Plus Triamcinolone
Arm/Group Description	EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution.	EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution mixed with 80 mg Triamcinolone.
Period Title: Overall Study
STARTED	19	21
COMPLETED	13	19
NOT COMPLETED	6	2

Baseline Characteristics

Arm/Group Title	Bupivicaine and Triamcinolone	Bupivicaine Alone	Total
Arm/Group Description	EUS guided celiac block with bupivicaine and triamcinolone Triamcinolone	EUS guided celiac block with bupivicaine only Bupivicaine alone	Total of all reporting groups
Overall Participants	21	19	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.5 (10.9)	44.1 (12.5)	41.7 (11.9)
Sex: Female, Male (Count of Participants)
Female	9 42.9%	9 47.4%	18 45%
Male	12 57.1%	10 52.6%	22 55%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Pain Disability Index
Description	The Pain Disability Index (PDI) measures patients' responses of the extent to which pain limits their abilities to carry out everyday tasks. The index is scored from 0 (no limitation) to 70 (severe limitation). A decrease in score of 10 points or more is regarded as indicating significant improvement in the ability to carry out daily activities.
Time Frame	1 month after block

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivicaine and Triamcinolone	Bupivicaine Alone
Arm/Group Description	EUS guided celiac block with bupivicaine and triamcinolone Triamcinolone	EUS guided celiac block with bupivicaine only Bupivicaine alone
Measure Participants	21	19
Count of Participants [Participants]	3 14.3%	3 15.8%

2. Secondary Outcome

Title	Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component
Description	The SF12 survey measures patients' impressions of their level of health and well-being. The results are reported as two scores: A physical component and a mental component, each of which is reported on a scale of 0 (lowest level of health) to 100 (excellent health). Scores that increase from baseline indicate an improvement in patients' feelings of well-being.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivicaine and Triamcinolone	Bupivicaine Alone
Arm/Group Description	EUS guided celiac block with bupivicaine and triamcinolone Triamcinolone	EUS guided celiac block with bupivicaine only Bupivicaine alone
Measure Participants	21	19
Mean (Standard Deviation) [units on a scale]	-0.2 (7.5)	1.7 (8.8)

Adverse Events

Arm/Group Title	Bupivicaine and Triamcinolone		Bupivicaine Alone
Arm/Group Description	EUS guided celiac block with bupivicaine and triamcinolone Triamcinolone		EUS guided celiac block with bupivicaine only Bupivicaine alone
All Cause Mortality
	Bupivicaine and Triamcinolone		Bupivicaine Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bupivicaine and Triamcinolone		Bupivicaine Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Bupivicaine and Triamcinolone		Bupivicaine Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/21 (19%)		2/19 (10.5%)
Gastrointestinal disorders
Abdominal pain	3/21 (14.3%)	3	1/19 (5.3%)	1
Gastric hematoma	1/21 (4.8%)	1	0/19 (0%)	0
Vascular disorders
Hypertension urgency	0/21 (0%)	0	1/19 (5.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.