## Protocol Section
### Identification Module
**NCT ID:** NCT00583479

**Brief Title:** Prospective Study of Celiac Block Injection: 1 vs. 2

**Official Title:** A Prospective Study of Celiac Block Technique: One Injection or Two?

#### Organization Study ID Info
**ID:** 0203-32
#### Organization
**Class:** OTHER
**Full Name:** Indiana University
### Status Module
#### Completion Date
**Date:** 2008-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-09-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-09-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-07

**Type:** ACTUAL

#### Start Date
**Date:** 2002-06

**Status Verified Date:** 2012-09

#### Study First Post Date
**Date:** 2007-12-31
**Type:** ESTIMATED
**Study First Submit Date:** 2007-12-20
**Study First Submit QC Date:** 2007-12-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Indiana University

#### Responsible Party

**Old Name Title:** Dr. Julia LeBlanc, MD, MPH

**Old Organization:** Indiana University

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this prospective randomized study is to compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region.

### Conditions Module

**Conditions:**

- Chronic Pancreatitis

- Pancreatic Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** subjects who get one medication injection into the celiac ganglion during the EUS

**Intervention Names:**

- Other: one injection into the celiac ganglion

**Label:** A

**Type:** OTHER

#### Arm Group 2

**Description:** subjects who get divided dose of the medication injected into two locations within the celiac ganglion during the EUS

**Intervention Names:**

- Other: two injections into the celiac ganglion

**Label:** B

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A

**Description:** one injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer

**Name:** one injection into the celiac ganglion

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- B

**Description:** two injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer

**Name:** two injections into the celiac ganglion

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region

**Time Frame:** 24-hour after the procedure; then every week thereafter until the subject is no longer in the study

#### Secondary Outcomes

**Measure:** change in medication use

**Time Frame:** at 24-hours after procedure and every week thereafter until the subject is no longer in the study

**Measure:** change is pain score

**Time Frame:** at 24-hours after procedure and every week thereafter until the subject is no longer in the study

**Measure:** complications related to CB

**Time Frame:** at 24-hours after procedure and every week thereafter until the subject is no longer in the study

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block will be eligible to participate in this study. Chronic pancreatitis and pancreatic cancer must be measured and documented by prior CT, ERCP, or EUS.
* Patients should not have significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit survivability of the sedation given or the procedure.
* Age \> or = to 18 years
* No evidence of significant active infection (ie. pneumonia, peritonitis, wound sepsis, etc)
* No evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc)
* 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.
* Patient must provide signed written informed consent.
* Patients that have had a previous celiac plexus block are eligible for this study

Exclusion Criteria:

* The patient's celiac trunk should be imaged clearly under endoscopic ultrasound. The patient's celiac plexus should be accessed easily with a needle for the medication injection. If this cannot be done safely due to the patient's anatomy (intervening blood vessel or tumor), the patient will not be eligible for the procedure or study.

**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

### References Module

#### References

**Citation:** LeBlanc JK, Al-Haddad M, McHenry L, Sherman S, Juan M, McGreevy K, Johnson C, Howard TJ, Lillemoe KD, DeWitt J. A prospective, randomized study of EUS-guided celiac plexus neurolysis for pancreatic cancer: one injection or two? Gastrointest Endosc. 2011 Dec;74(6):1300-7. doi: 10.1016/j.gie.2011.07.073. Epub 2011 Oct 13.

**PMID:** 22000795

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### 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: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M13115

- Name: Pancreatitis

- Relevance: HIGH

- As Found: Pancreatitis

- ID: M26260

- Name: Pancreatitis, Chronic

- Relevance: HIGH

- As Found: Chronic Pancreatitis

- ID: M5696

- Name: Celiac Disease

- 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: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Pancreatic Cancer

### Condition Browse Module - Meshes

- ID: D000010195

- Term: Pancreatitis

- ID: D000050500

- Term: Pancreatitis, Chronic

### Misc Info Module

- Version Holder: 2024-05-24
