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PainNCT01166529

Endoscopic Ultrasound-guided Celiac Plexus Neurolysis in the Management of Pain in Abdominal Non-pancreatic Malignancies

A study testing EUS-guided Celiac Plexus Neurolysis in people with Pain and Cancer, run by Northwestern University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Cancer
What is being tested?
EUS-guided Celiac Plexus Neurolysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Aug 2010to Jul 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: 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.

Conditions
Pain, Cancer
Being tested
EUS-guided Celiac Plexus Neurolysis
Medical subject headings
Pain, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EUS-guided Celiac Plexus NeurolysisProcedure or surgery

    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.

Study groups in NCT01166529
Study groupRoleWhat they receive
EUS-CPNExperimentalNot described
Receives: Procedure: EUS-guided Celiac Plexus Neurolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference between the mean pain score prior to and 1 month after the procedure, as determined by the Brief Pain Inventory (BPI)

    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

    Measured: 1 month

Secondary outcomes (3)

  1. 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).

    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.

    Measured: 2 months

  2. 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.

    Measured: 2 months

  3. Narcotic use over a 24-hour period will be documented each time the Brief Pain Inventory (BPI) is completed

    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.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJul 2013
  4. Study completionJul 2013

Why it stopped: Unable to identify appropriate patients.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01166529
Sponsor's protocol ID
NU protocol #0917 (eIRB 20311)
Status last verified
Sep 2014
First submitted
19 Jul 2010
Last updated
25 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18837908

  • 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.

    PubMed 19179150

  • 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.

    PubMed 19179165

  • 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.

    PubMed 19137428

  • 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.

    PubMed 6646795

  • 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.

    PubMed 7165009

Questions about this trial

What is this clinical trial studying?

A study testing EUS-guided Celiac Plexus Neurolysis in people with Pain and Cancer, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01166529, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.

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