Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRB # 0702-25 | |||
| Clarian Values Grant: vfr-262 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or unresectable pancreatic adenocarcinoma.
Hypotheses:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | subject randomized to 10ml of dehydrated alcohol |
|
| B | Experimental | subject randomized to 20ml of dehydrated alcohol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dehydrated alcohol | Drug | subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection | Pain will be assessed at baseline 24 hours after the procedure and weekly thereafter, until the subject reports no subjective pain relief from the procedure. Pain relief is defined as a decrease in 2 points on a 0-10 point pain rating scale. Zero is no pain and 10 is the worst pain. | baseline up to 1 year |
Not provided
Not provided
Inclusion Criteria:
Subjects must not have a coagulopathy (platelet <50,000, INR>1.5, or bleeding disorder, or on blood thinners) Subjects with platelets below 50,000 will not be eligible to participate in this study due to the risk of bleeding. Patients will be asked to discontinue use of non-steroidals for 5 days prior to the procedure. Patients on plavix will be asked to discontinue use for 7 days prior to the procedure if they are clinically able to do so. Patients on coumadin or lovenox will also need to discontinue use prior to the procedure, but decisions regarding their management will be made on an individual basis as per our usual standards of care.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julia LeBlanc, MD, MPH | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clarian Health: Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 10 mL of Alcohol Injection | subject randomized to 10ml of dehydrated alcohol |
| FG001 | 20 mL of Alcohol Injection | subject randomized to 20ml of dehydrated alcohol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 10 mL of Alcohol Injection | subject randomized to 10ml of dehydrated alcohol |
| BG001 | 20 mL of Alcohol Injection | subject randomized to 20ml of dehydrated alcohol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection | Pain will be assessed at baseline 24 hours after the procedure and weekly thereafter, until the subject reports no subjective pain relief from the procedure. Pain relief is defined as a decrease in 2 points on a 0-10 point pain rating scale. Zero is no pain and 10 is the worst pain. | Posted | Dec 2010 | Mean | Standard Deviation | units on a scale | baseline up to 1 year |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 mL of Alcohol Injection | subject randomized to 10ml of dehydrated alcohol |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia K. LeBlanc, MD | Indiana University Medical Center | (317) 948-8125 | juleblan@iupui.edu |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 20 mL of Alcohol Injection | subject randomized to 20ml of dehydrated alcohol | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |