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Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT00658736
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Tyler Stevens, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Pancreatitis
Interventions Drug: Triamcinolone
Drug: Bupivicaine alone
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bupivicaine Alone Bupivicaine Plus Triamcinolone
Hide 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
Arm/Group Title Bupivicaine and Triamcinolone Bupivicaine Alone Total
Hide 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 Number of Baseline Participants 21 19 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 40 participants
39.5  (10.9) 44.1  (12.5) 41.7  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
Female
9
  42.9%
9
  47.4%
18
  45.0%
Male
12
  57.1%
10
  52.6%
22
  55.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Change in Pain Disability Index
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivicaine and Triamcinolone Bupivicaine Alone
Hide Arm/Group Description:

EUS guided celiac block with bupivicaine and triamcinolone

Triamcinolone

EUS guided celiac block with bupivicaine only

Bupivicaine alone

Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivicaine and Triamcinolone Bupivicaine Alone
Hide Arm/Group Description:

EUS guided celiac block with bupivicaine and triamcinolone

Triamcinolone

EUS guided celiac block with bupivicaine only

Bupivicaine alone

Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (7.5) 1.7  (8.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupivicaine and Triamcinolone Bupivicaine Alone
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bupivicaine and Triamcinolone Bupivicaine Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bupivicaine and Triamcinolone Bupivicaine Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/21 (19.05%)      2/19 (10.53%)    
Gastrointestinal disorders     
Abdominal pain   3/21 (14.29%)  3 1/19 (5.26%)  1
Gastric hematoma   1/21 (4.76%)  1 0/19 (0.00%)  0
Vascular disorders     
Hypertension urgency   0/21 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tyler Stevens
Organization: Cleveland Clinic
Phone: 216 445-1996
EMail: stevent@ccf.org
Layout table for additonal information
Responsible Party: Tyler Stevens, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00658736     History of Changes
Other Study ID Numbers: CCF IRB 07-729
First Submitted: April 9, 2008
First Posted: April 15, 2008
Results First Submitted: March 13, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017