Randomized Trial of EUS Neurolysis in Pancreas Cancer

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Celiac Plexus Neurolysis

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Pancreatic neoplasm

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 3.1 Unresectable (T4 or M1 or non-regional lymph nodes) or inoperable (due to medical comorbidity) carcinoma of the pancreas as determined by CT or EUS. Patients with extensive portal vein or superior mesenteric vein involvement (T3 by 6th Ed. AJCC staging manual) will be included only if the consulting surgeon feels the patients is unresectable based on the CT scan information. 3.2 Presence of mid-abdominal pain ( 3 on VAS scale) at least 2 days per week, lasting at least 1 hour per day. 3.3 No known coagulopathy as measured by Prothrombin time (INR) 1.5. Pre-EUS INR is not required unless clinically indicated due to known warfarin use or suspected coagulopathy. 3.4 Patient must not require more than 2 l/min oxygen supplementation to maintain saturation >90%. 3.5 > 6 months since previous myocardial infarction or angina. 3.6 ≥ 4 weeks since previous surgery. 3.7 No institution or change in chemotherapy or radiotherapy within 7 days prior (or 14 days post) ESU-CPN. See section 7.0 and 7.1 for details of chemotherapy and radiotherapy allowances. 3.8 Platelets ≥ 50,000. Pre-EUS CBC is not required unless clinically indicated due to known or suspected coagulopathy. 3.9 Life expectancy > 3 months 3.10 Signed and dated informed consent. Exclusion Criteria: Unable to sign informed consent

Sites / Locations

Mayo Clinic Scottsdale
Mayo Clinic Jacksonville

Outcomes

Primary Outcome Measures

To evaluate the efficacy of treatment of ethanol injection versus placebo

injection for pain in pancreatic cancer patients at 1 month and 3 months.

Secondary Outcome Measures

To evaluate mortality and surgical morbidity at 1 month and 3 months

To evaluate magnitude of narcotic use after treatment at 1 month and 3 months

To estimate the period of time pain scores will remain below baseline levels

To estimate the effect of treatment on quality of life at 1 month and 3 month

Full Information

NCT ID

NCT00279292

First Posted

January 17, 2006

Last Updated

October 13, 2015

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT00279292

Brief Title

Randomized Trial of EUS Neurolysis in Pancreas Cancer

Official Title

Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

Brief Summary

This is a clinical trial to determine more effective methods of controlling the pain in pancreatic cancer. Although narcotic pain medication are effective, they have many side effects and are underutilized due to social stigma and fear of addiction. Celiac plexus neurolysis is a nerve block procedure that has been shown to be effective in uncontrolled clinical trials. We hypothesized that celiac plexus neurolysis plus pain medication will be more effective and have fewer side effects than pain medication alone. We are evaluating the effectiveness of this standard pain medications with or without celiac plexus neurolysis in a randomized controlled trial. One half of the participants will receive pain medications only and the other half will receive pain medications plus neurolysis, delivered via an endoscopic ultrasound device placed in the stomach.

Detailed Description

This is a phase III randomized blinded sham controlled trial of endoscopic ultrasound guided celiac plexus neurolysis. Patients with pancreatic cancer who are unresectable and who have significant pain (> 3 on 0-10 scale) will be enrolled. At the time of a staging endoscopic ultrasound, patients will be randomized to celiac neurolysis or sham (injection of same medication into lumen of stomach). Neurolysis will be performed using standard bupivicaine and ethanol. Patients will be followed for at least 3 months for pain, quality of life and narcotic usage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Neoplasms

Keywords

Pancreatic neoplasm

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Celiac Plexus Neurolysis

Primary Outcome Measure Information:

Title

To evaluate the efficacy of treatment of ethanol injection versus placebo

Title

injection for pain in pancreatic cancer patients at 1 month and 3 months.

Secondary Outcome Measure Information:

Title

To evaluate mortality and surgical morbidity at 1 month and 3 months

Title

To evaluate magnitude of narcotic use after treatment at 1 month and 3 months

Title

To estimate the period of time pain scores will remain below baseline levels

Title

To estimate the effect of treatment on quality of life at 1 month and 3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 3.1 Unresectable (T4 or M1 or non-regional lymph nodes) or inoperable (due to medical comorbidity) carcinoma of the pancreas as determined by CT or EUS. Patients with extensive portal vein or superior mesenteric vein involvement (T3 by 6th Ed. AJCC staging manual) will be included only if the consulting surgeon feels the patients is unresectable based on the CT scan information. 3.2 Presence of mid-abdominal pain ( 3 on VAS scale) at least 2 days per week, lasting at least 1 hour per day. 3.3 No known coagulopathy as measured by Prothrombin time (INR) 1.5. Pre-EUS INR is not required unless clinically indicated due to known warfarin use or suspected coagulopathy. 3.4 Patient must not require more than 2 l/min oxygen supplementation to maintain saturation >90%. 3.5 > 6 months since previous myocardial infarction or angina. 3.6 ≥ 4 weeks since previous surgery. 3.7 No institution or change in chemotherapy or radiotherapy within 7 days prior (or 14 days post) ESU-CPN. See section 7.0 and 7.1 for details of chemotherapy and radiotherapy allowances. 3.8 Platelets ≥ 50,000. Pre-EUS CBC is not required unless clinically indicated due to known or suspected coagulopathy. 3.9 Life expectancy > 3 months 3.10 Signed and dated informed consent. Exclusion Criteria: Unable to sign informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael B Wallace, MD MPH

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic Scottsdale

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

Mayo Clinic Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Pancreatic Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial