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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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EUS-CPN

Group Type EXPERIMENTAL

EUS-guided Celiac Plexus Neurolysis

Intervention Type PROCEDURE

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.

Interventions

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EUS-guided Celiac Plexus Neurolysis

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No