EUS Guided Neurolysis Celiac Block w/wo Bupivacaine in Patient Being Treated Palliatively for Pancreatic Cancer

NCT02682082 | Terminated

• 1 other identifier: CE 15.246
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to determine if EUS-CPN without Bupivacaine (versus EUS-CPN with Bupivacaine) can reduce pain scores and improve quality of life in patients with inoperable pancreatic cancer by reducing the morbidity due to narcotic side effects (e.g. nausea, excessive sedation, constipation).

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer; Pain Management; Celiac plexus neurolysis; Bupivacaine; Palliative treatment

Outcome Measures

Primary Outcomes (1)

• Difference in pain scores at 1 month and end of the trial

  1 month and 120 days post procedure

Secondary Outcomes (3)

• Difference in quality of life scores at 1 month and end of the trial

  1 month and 120 days post procedure

• Difference in cumulative narcotic usage at 1 month and end of the trial

  1 month and 120 days post procedure

• Difference in survival

  1 month and 120 days post procedure

Study Arms (2)

Neurolysis without Bupivacaine

EXPERIMENTAL

Experimental Group: Endoscopic ultrasound guided celiac plexus Neurolysis without Bupivacaine so only with Absolute Alcohol 20 mL

Procedure: Endoscopic ultrasound-guided celiax plexus neurolysis

Neurolysis with Bupivacaine

ACTIVE COMPARATOR

Endoscopic ultrasound guided celiac plexus Neurolysis with Bupivacaine (0.5% Bupivicaine 20mL + Absolute Alcohol 20 mL)

Procedure: Endoscopic ultrasound-guided celiax plexus neurolysis; Drug: Bupivacaine

Interventions

Endoscopic ultrasound-guided celiax plexus neurolysis PROCEDURE

Endoscopic ultrasound-guided celiax plexus neurolysis

Neurolysis with Bupivacaine; Neurolysis without Bupivacaine

Bupivacaine DRUG

Endoscopic ultrasound-guided celiax plexus neurolysis w/wo Bupivacaine

Neurolysis with Bupivacaine

Eligibility Criteria

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

You may qualify if:

• Confirmed malignant pancreatic lesion involving the pancreatic genu, body, or tail
• Abdominal or back pain considered to be potentially related to the tumor
• New onset pain (\<3 months)
• Constant
• Centrally located
• With or without irradiation to the back
• No obvious other source of pain based on history and physical examination by the attending endosonographer
• No possibility of surgical management
• Signed, informed consent

You may not qualify if:

• Allergy to bupivicaine
• Age \< 18 years
• Inability or unwillingness to give informed consent

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

CHUM

Montreal, Quebec, Canada

Location

Related Publications (7)

• Seicean A. Celiac plexus neurolysis in pancreatic cancer: the endoscopic ultrasound approach. World J Gastroenterol. 2014 Jan 7;20(1):110-7. doi: 10.3748/wjg.v20.i1.110.

  PMID: 24415863 BACKGROUND

• Wyse JM, Chen YI, Sahai AV. Celiac plexus neurolysis in the management of unresectable pancreatic cancer: when and how? World J Gastroenterol. 2014 Mar 7;20(9):2186-92. doi: 10.3748/wjg.v20.i9.2186.

  PMID: 24605017 BACKGROUND

• Seicean A, Cainap C, Gulei I, Tantau M, Seicean R. Pain palliation by endoscopic ultrasound-guided celiac plexus neurolysis in patients with unresectable pancreatic cancer. J Gastrointestin Liver Dis. 2013 Mar;22(1):59-64.

  PMID: 23539392 BACKGROUND

• Levy MJ, Chari ST, Wiersema MJ. Endoscopic ultrasound-guided celiac neurolysis. Gastrointest Endosc Clin N Am. 2012 Apr;22(2):231-47, viii. doi: 10.1016/j.giec.2012.04.003. Epub 2012 Apr 25.

  PMID: 22632946 BACKGROUND

• Sakamoto H, Kitano M, Komaki T, Imai H, Kamata K, Kudo M. Endoscopic ultrasound-guided neurolysis in pancreatic cancer. Pancreatology. 2011;11 Suppl 2:52-8. doi: 10.1159/000323513. Epub 2011 Apr 5.

  PMID: 21471704 BACKGROUND

• Penman ID. Coeliac plexus neurolysis. Best Pract Res Clin Gastroenterol. 2009;23(5):761-6. doi: 10.1016/j.bpg.2009.05.003.

  PMID: 19744638 BACKGROUND

• Ishiwatari H, Hayashi T, Yoshida M, Ono M, Masuko H, Sato T, Miyanishi K, Sato Y, Takimoto R, Kobune M, Miyamoto A, Sonoda T, Kato J. Phenol-based endoscopic ultrasound-guided celiac plexus neurolysis for East Asian alcohol-intolerant upper gastrointestinal cancer patients: a pilot study. World J Gastroenterol. 2014 Aug 14;20(30):10512-7. doi: 10.3748/wjg.v20.i30.10512.

  PMID: 25132769 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Anand Sahai, M.D

  Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur Titulaire de Médecine / Professor of Medicine Chef / Chief, Service de Gastroentérologie

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 15, 2016
• Study Start: May 27, 2016
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: May 14, 2020

Record last verified: 2020-05

Locations

CA (1)