Trial Comparing EUS-guided Radiofrequency Ablation vs. EUS-guided Celiac Plexus Neurolysis

NCT03152487 | Completed DMC

• 1 other identifier: 1035541
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic cancer is the second most common gastrointestinal malignancy. Abdominal discomfort is a main symptom in patients with pancreatic cancer. Approximately 75% have pain at diagnosis and over 90% in advanced stages. Pain control is an important part of the plan of care for patients with pancreatic cancer.. The celiac plexus is a group of nerves that supply organs in the abdomen. EUS-guided celiac plexus neurolysis (EUS-CPN) has been widely used for pain management in patients with pancreatic cancer. Radiofrequency ablation of celiac ganglia or celiac plexus (EUS-RFA) is also being performed to alleviate abdominal pain in pancreatic cancer patients. However currently no comparative studies exist comparing EUS-CPN with EUS-RFA. The purpose of the study is to compare EUS-CPN with EUS-RFA for pain management in pancreatic patients, in order to determine which technique is better at improving pain in pancreatic cancer patients.

Conditions

Pancreatic Carcinoma Metastatic; Pancreatic Adenocarcinoma; Pancreatic Neoplasms; Pancreatic Cancer; Pancreatic Cancer, Adult

Keywords

endoscopic ultrasound; celiac plexus neurolysis; radiofrequency ablation; pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Subject assessment of abdominal pain

  Abdominal pain will be assessed with pain scores from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer module (QLQ-PAN26). The questionnaire has 26 questions with scoring ranging from a minimum of 26 to a maximum of 104. The higher the score, the worse the subject's quality of life rating.

  Baseline to 4 week follow up

Secondary Outcomes (6)

• Subject assessment of Quality of Life.

  Baseline; 2 week follow up; 4 week follow up

• Narcotic Use

  Initial visit; 2 week follow up; 4 week follow up

• Crossover to alternate technique

  48 hours post procedure; 2 week follow up; 4 week follow up

• Adverse effects, and endoscopic adverse events

  48 hours post procedure; 2 week follow up; 4 week follow up

• Survival rate

  2 week follow up; 4 week follow up

Study Arms (2)

Celiac Plexus Neurolysis

ACTIVE COMPARATOR

CPN will be undertaken at the celiac space which is located between the aorta and the celiac artery origin. A 22 or 19-gauge Fine Needle Aspiration (FNA) needle is used, and its tip is placed slightly anterior and cephalic to the origin of the celiac artery. Aspiration is first performed using a syringe to ensure that vascular puncture has not occurred. 10 mL Bupivacaine is injected first, followed by 20 mL of 98% alcohol.

Other: Celiac Plexus Neurolysis

Radiofrequency Ablation

ACTIVE COMPARATOR

Once the celiac ganglia are identified on EUS, a 19-gauge FNA needle is inserted into the center of the ganglion or area of celiac plexus under EUS guidance. The radiofrequency (RF) probe (EMcision, Montreal, Canada) is advanced through the FNA needle. Radiofrequency ablation is performed via the probe for 90 seconds, followed by a 90 second rest and repeated as required.

Other: Radiofrequency Ablation

Interventions

Celiac Plexus Neurolysis OTHER

This intervention involves accessing the Celiac Plexus Nerve via endoscopic guided ultrasound and then injecting the nerve bundle with bupivacaine.

Celiac Plexus Neurolysis

Radiofrequency Ablation OTHER

Radiofrequency ablation is performed via the probe for 90 seconds, followed by a 90 second rest. This is repeated until the entire ganglion becomes hyperechoic on EUS.

Radiofrequency Ablation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years
• The subject is capable of understanding and complying with protocol requirements.
• The subject is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
• Abdominal pain typical for pancreatic cancer
• Cross-sectional imaging findings consistent with pancreatic cancer
• Pancreatic cancer confirmed by EUS-FNA in patients referred for suspected pancreatic cancer OR Patients with known diagnosis of pancreatic cancer
• Inoperable pancreatic cancer as determined during EUS or prior CT

You may not qualify if:

• Age \<19 years
• Unable to obtain consent for the procedure from the patient
• Unable to safely undergo EUS for any reason
• Irreversible coagulopathy (Prothrombin time \> 18 secs, platelet count \< 50,000/ml)
• Previous CPN or other neurolytic block that could affect pancreatic cancer-related pain or had implanted epidural or intrathecal analgesic therapy
• Another cause for abdominal pain such as pseudocyst, ulcer or other intraabdominal disorder
• Pregnant women will be excluded. This will be confirmed by self-report. Pregnancy in females of childbearing potential will be determined by routine preoperative urine or serum Human Chorionic Gonadotropin (HCG) testing.

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Center for Interventional Endoscopy - Florida Hospital

Orlando, Florida, 32803, United States

Location

Related Publications (11)

• Yan BM, Myers RP. Neurolytic celiac plexus block for pain control in unresectable pancreatic cancer. Am J Gastroenterol. 2007 Feb;102(2):430-8. doi: 10.1111/j.1572-0241.2006.00967.x. Epub 2006 Nov 13.

  PMID: 17100960 BACKGROUND

• Carr DB, Goudas LC, Balk EM, Bloch R, Ioannidis JP, Lau J. Evidence report on the treatment of pain in cancer patients. J Natl Cancer Inst Monogr. 2004;(32):23-31. doi: 10.1093/jncimonographs/lgh012.

  PMID: 15263038 BACKGROUND

• World Health Organization. Cancer pain relief, 2nd Ed. Geneva: WHO, 2006

  BACKGROUND

• 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.

  PMID: 19179165 BACKGROUND

• Gunaratnam NT, Sarma AV, Norton ID, Wiersema MJ. A prospective study of EUS-guided celiac plexus neurolysis for pancreatic cancer pain. Gastrointest Endosc. 2001 Sep;54(3):316-24. doi: 10.1067/mge.2001.117515.

  PMID: 11522971 BACKGROUND

• Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

  PMID: 3785962 BACKGROUND

• Kastler A, Aubry S, Sailley N, Michalakis D, Siliman G, Gory G, Lajoie JL, Kastler B. CT-guided stellate ganglion blockade vs. radiofrequency neurolysis in the management of refractory type I complex regional pain syndrome of the upper limb. Eur Radiol. 2013 May;23(5):1316-22. doi: 10.1007/s00330-012-2704-y. Epub 2012 Nov 9.

  PMID: 23138389 BACKGROUND

• Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.

  PMID: 8445433 BACKGROUND

• Bang JY, Hasan MK, Sutton B, Holt BA, Navaneethan U, Hawes R, Varadarajulu S. Intraprocedural increase in heart rate during EUS-guided celiac plexus neurolysis: Clinically relevant or just a physiologic change? Gastrointest Endosc. 2016 Nov;84(5):773-779.e3. doi: 10.1016/j.gie.2016.03.1496. Epub 2016 Apr 2.

  PMID: 27048974 BACKGROUND

• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

  PMID: 20189503 BACKGROUND

• Bang JY, Sutton B, Hawes RH, Varadarajulu S. EUS-guided celiac ganglion radiofrequency ablation versus celiac plexus neurolysis for palliation of pain in pancreatic cancer: a randomized controlled trial (with videos). Gastrointest Endosc. 2019 Jan;89(1):58-66.e3. doi: 10.1016/j.gie.2018.08.005. Epub 2018 Aug 16.

  PMID: 30120957 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic cancer, adult

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Shyam S Varadarajulu, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will randomized to either a group that receives Celiac Plexus Neurolysis or Radiofrequency Ablation.

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 15, 2017
• Study Start: April 24, 2017
• Primary Completion: April 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)