## Protocol Section
### Identification Module
**NCT ID:** NCT00578279

**Brief Title:** Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN)With Alcohol in Unresectable Pancreatic Cancer: a Pilot Study

**Official Title:** Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN) With Alcohol in Patients With Locally Advanced and Unresectable Pancreatic Adenocarcinoma: A Randomized Pilot Study

#### Organization Study ID Info
**ID:** 0702-25
#### Organization
**Class:** OTHER
**Full Name:** Indiana University
#### Secondary ID Infos
**ID:** IRB # 0702-25
**ID:** Clarian Values Grant: vfr-262
### Status Module
#### Completion Date
**Date:** 2009-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-10-19

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-09-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-06

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-10-19

**Type:** ESTIMATED

**Results First Submit Date:** 2010-09-23

**Results First Submit QC Date:** 2012-09-18

#### Start Date
**Date:** 2007-03

**Status Verified Date:** 2010-06

#### Study First Post Date
**Date:** 2007-12-21
**Type:** ESTIMATED
**Study First Submit Date:** 2007-12-19
**Study First Submit QC Date:** 2007-12-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Indiana University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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:

1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma.
2. Effective pain relief obtained from EUS-CPN will be related to better quality of life (QOL)

### Conditions Module

**Conditions:**

- Pancreatic Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** subject randomized to 10ml of dehydrated alcohol

**Intervention Names:**

- Drug: dehydrated alcohol

**Label:** A

**Type:** OTHER

#### Arm Group 2

**Description:** subject randomized to 20ml of dehydrated alcohol

**Intervention Names:**

- Drug: dehydrated alcohol

**Label:** B

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A

- B

**Description:** subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure

**Name:** dehydrated alcohol

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection

**Time Frame:** baseline up to 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* A total of 20 consecutive subjects with locally advanced or unresectable pancreatic adenocarcinoma (stage II to IV) with pain (abdominal and/or back). Subjects with known or suspected unresectable pancreatic adenocarcinoma will be recruited for this study, as a diagnosis of unresectable pancreatic adenocarcinoma is often made during the endoscopic ultrasound (EUS) procedure.
* Subjects must have documented disease by computed tomography (CT), endoscopic retrograde cholangio-pancreatography (ERCP), or EUS.
* Subjects undergoing EUS for pancreatic cancer staging.
* Subjects undergoing pancreatic cancer surgery are eligible for study entry beginning 5 days after the operation if they have not had an intraoperative celiac plexus neurolysis.
* No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.

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.

* Subjects must provide signed written informed consent.
* A baseline pain score is not required, however, subjects must be having pain that is requiring a stable dose of pain medication for control of pain.

Exclusion Criteria:

* Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical).
* Presence of an implanted epidural or intrathecal analgesic therapy. Subjects with psychiatric illness that affects their ability to assess quality of life or compliance with the protocol.
* Subjects with uncorrectable coagulopathy
* Subjects with an allergy to bupivacaine or alcohol.
* Presence of an aneurysm in the abdominal aorta, celiac trunk, or superior mesenteric artery.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Indianapolis

**Country:** United States

**Facility:** Clarian Health: Indiana University Hospital

**State:** Indiana

**Zip:** 46202

#### Overall Officials

**Official 1:**

**Affiliation:** Indiana University

**Name:** Julia LeBlanc, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: HIGH

- As Found: Pancreatic Cancer

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5696

- Name: Celiac Disease

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Pancreatic Cancer

### Condition Browse Module - Meshes

- ID: D000010190

- Term: Pancreatic Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000891

- Term: Anti-Infective Agents, Local

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: HIGH

- As Found: Ureteral catheter

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4215

- Name: Anti-Infective Agents, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000431

- Term: Ethanol

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** 10 mL of Alcohol Injection

**Description:** subject randomized to 10ml of dehydrated alcohol

**ID:** EG000

**Other Num at Risk:** 10

**Serious Number At Risk:** 10

**Title:** 10 mL of Alcohol Injection

**Group ID:** EG001

**Title:** 20 mL of Alcohol Injection

**Description:** subject randomized to 20ml of dehydrated alcohol

**ID:** EG001

**Other Num at Risk:** 10

**Serious Number At Risk:** 10

**Title:** 20 mL of Alcohol Injection

**Frequency Threshold:** 1

**Time Frame:** 12 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 10

**Group ID:** BG001

**Value:** 10

**Group ID:** BG002

**Value:** 20

**Units:** Participants

### Group

**ID:** BG000

**Title:** 10 mL of Alcohol Injection

**Description:** subject randomized to 10ml of dehydrated alcohol

### Group

**ID:** BG001

**Title:** 20 mL of Alcohol Injection

**Description:** subject randomized to 20ml of dehydrated alcohol

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 14

**Value:** 66

#### Measurement

**Group ID:** BG001

**Spread:** 10

**Value:** 63

#### Measurement

**Group ID:** BG002

**Spread:** 12

**Value:** 64

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 11

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 9

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 20

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** juleblan@iupui.edu
**Organization:** Indiana University Medical Center
**Phone:** (317) 948-8125
**Title:** Julia K. LeBlanc, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Anticipated Posting Date:** 2010-12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.8
- **Upper Limit:** 
- **Value:** 7.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9.2
- **Upper Limit:** 
- **Value:** 8.4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** baseline up to 1 year
**Title:** The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** subject randomized to 10ml of dehydrated alcohol
**ID:** OG000
**Title:** 10 mL of Alcohol Injection
##### Group
**Description:** subject randomized to 20ml of dehydrated alcohol
**ID:** OG001
**Title:** 20 mL of Alcohol Injection
### Participant Flow Module
#### Group
**Description:** subject randomized to 10ml of dehydrated alcohol
**ID:** FG000
**Title:** 10 mL of Alcohol Injection
#### Group
**Description:** subject randomized to 20ml of dehydrated alcohol
**ID:** FG001
**Title:** 20 mL of Alcohol Injection
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True