- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01166529
Endoscopic Ultrasound-guided Celiac Plexus Neurolysis in the Management of Pain in Abdominal Non-pancreatic Malignancies
September 23, 2014 updated by: Rajesh Keswani, Northwestern University
Endoscopic Ultrasound (EUS)-Guided Celiac Plexus Neurolysis (CPN) in the Management of Pain in Abdominal Non-pancreatic Malignancies
Celiac plexus neurolysis (CPN) has been performed for nearly 100 years to alleviate the abdominal pain associated with pancreatic malignancy and other conditions, and is usually undertaken at a late stage in the disease process, when analgesic options have been largely exhausted or have led to significant and often unacceptable side effects.
Until recently, CPN was most commonly performed under radiographic guidance; however, in the last 10 years, CPN has been routinely performed under endoscopic ultrasound (EUS) guidance.
Several case series have demonstrated the efficacy and safety of this technique when used to treat the pain associated with pancreatic malignancy and/or chronic pancreatitis.
However, the efficacy of EUS-guided CPN in the treatment of pain related to non-pancreatic malignancies has yet to be described.
The goal of this study is to assess the efficacy of EUS-guided CPN in the management of pain in patients with abdominal non-pancreatic malignancies.
Our hypothesis is that EUS-guided CPN will provide adequate pain relief in these patients.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of an unresectable, non-pancreatic malignancy, including gastric, small intestinal, or proximal colonic malignancies, as well as malignancies of the liver and bile ducts (based on above celiac plexus innervations)
- Pain directly related to the primary malignant process, as determined by the referring oncologist
- Pain determined to be refractory to standard medical therapy, or when the medical therapy is ineffective due to certain limitations (such as severe constipation), as determined by the referring oncologist
- Willingness to undergo EUS-guided CPN
- Age > 18 years
- ECOG performance status of grades 0-3 [7]
- The patient will need to sign informed consent prior to inclusion in this study
Exclusion Criteria:
- Unable or unwilling to undergo an EUS-guided CPN
- Contraindication to anesthesia, as determine during the preoperative clearance process
- Refractory coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000), or aspirin and/or clopidogrel use within 7 days of procedure
- Current pregnancy
- Prior celiac plexus block/neurolysis
- Allergy to local anesthetics
- ECOG performance status of grade 4 or higher
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: EUS-CPN
|
All patients will receive anesthesia.
The linear echo-endoscope will be advanced into the proximal stomach.
It will be noted whether the tumor is seen in the celiac axis, if there is flow in the celiac artery, and if the celiac ganglia are seen.
The celiac ganglia will be injected directly with 10cc of 0.25% bupivicaine followed by 10cc of 98% dehydrated alcohol.
If the celiac ganglia cannot be identified, the posterior and anterior aspects of celiac artery take-off will be injected in a similar manner (twice the volume).
Flow in the celiac axis will be confirmed.
All injections will be performed with a standard EUS injection needle made especially for CPN .
Prior to injection, aspiration will be performed through the needle to ensure that no blood is aspirated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference between the mean pain score prior to and 1 month after the procedure, as determined by the Brief Pain Inventory (BPI)
Time Frame: 1 month
|
The BPI will be filled out just prior to and 1 month after the procedure to assess the difference in the mean pain score after the procedure
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in mean pain scores before and at 1 day after the procedure, 7 days after the procedure, 14 days after the procedure, and at 2 months after the procedure, as determined by the Brief Pain Inventory (BPI).
Time Frame: 2 months
|
The BPI will be filled out just prior to the procedure and after the procedure at the above intervals (up to 2 months) to assess the difference in the mean pain scores after the procedure.
|
2 months
|
Difference in the mean 'level of interference of pain with daily life' score, as determined by the Brief Pain Inventory (BPI). This score will be determined before and after the procedure, determined at the same intervals as mean pain scores.
Time Frame: 2 months
|
2 months
|
|
Narcotic use over a 24-hour period will be documented each time the Brief Pain Inventory (BPI) is completed
Time Frame: 2 months
|
Names, doses, and quantity of pain medications will be reported and converted to an equianalgesic dose (mg/day) of orally administered morphine.
The difference in equianalgesic doses (mg/day) will be determined at the same intervals as mean pain scores.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raj N Keswani, MD, Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
- Christo PJ, Mazloomdoost D. Interventional pain treatments for cancer pain. Ann N Y Acad Sci. 2008 Sep;1138:299-328. doi: 10.1196/annals.1414.034.
- Chak A. What is the evidence for EUS-guided celiac plexus block/neurolysis? Gastrointest Endosc. 2009 Feb;69(2 Suppl):S172-3. doi: 10.1016/j.gie.2008.12.022. No abstract available.
- Penman ID, Rosch T; EUS 2008 Working Group. EUS 2008 Working Group document: evaluation of EUS-guided celiac plexus neurolysis/block (with video). Gastrointest Endosc. 2009 Feb;69(2 Suppl):S28-31. doi: 10.1016/j.gie.2008.11.004. No abstract available.
- Puli SR, Reddy JB, Bechtold ML, Antillon MR, Brugge WR. EUS-guided celiac plexus neurolysis for pain due to chronic pancreatitis or pancreatic cancer pain: a meta-analysis and systematic review. Dig Dis Sci. 2009 Nov;54(11):2330-7. doi: 10.1007/s10620-008-0651-x. Epub 2009 Jan 10.
- Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197-210. doi: 10.1016/0304-3959(83)90143-4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (ACTUAL)
July 1, 2013
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
July 19, 2010
First Submitted That Met QC Criteria
July 20, 2010
First Posted (ESTIMATE)
July 21, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
September 25, 2014
Last Update Submitted That Met QC Criteria
September 23, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU protocol #0917 (eIRB 20311)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on EUS-guided Celiac Plexus Neurolysis
-
Asian Institute of Gastroenterology, IndiaUnknown
-
University of Alabama at BirminghamAdventHealthCompletedPain | Pancreatic CancerUnited States
-
Centre hospitalier de l'Université de Montréal...CompletedInoperable, Painful Pancreatic CancerCanada
-
Changhai HospitalThe Third Xiangya Hospital of Central South University; Eastern Hepatobiliary... and other collaboratorsUnknownPancreatic CancerChina
-
Chinese University of Hong KongRecruitingPancreatic Cancer Non-resectable | Pain Cancer | Tumor PancreasHong Kong
-
Indiana UniversityRecruitingChronic PancreatitisUnited States
-
National Institute of Diabetes and Digestive and...Completed
-
Mansoura UniversityCompleted
-
Chinese University of Hong KongTerminatedIntractable Abdominal Pain Secondary to Inoperable MalignancyChina
-
Orlando Health, Inc.RecruitingChronic PancreatitisUnited States