|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT01318590 |
|
Date of registration:
|
17/03/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis
|
|
Scientific title:
|
Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis |
|
Date of first enrolment:
|
November 18, 2011 |
|
Target sample size:
|
2 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT01318590 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Belgium
|
Canada
| | | | | | |
|
Contacts
|
|
Name:
|
Anand V Sahai, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHUM |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pancreatitis, Chronic
|
|
Intervention(s)
|
|
Other: EUS procedure
|
|
Drug: EUS procedure with drug injection
|
|
Primary Outcome(s)
|
|
Pain reduction on Likert scale
[Time Frame: each month for six months]
|
|
Secondary Outcome(s)
|
|
Quality of Life (QOL) score
[Time Frame: each month for six months]
|
|
Secondary ID(s)
|
|
CE 10 160
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|