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

NCT ID: NCT02682082

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-27
• Study Completion Date: 2019-06-14

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).

Detailed Description

Pancreatic malignancies are the second highest incident gastrointestinal malignancy in Canada. From cancer mortality statistics in 2014, there were 4,700 new cases of pancreatic malignancies second only to colorectal cancer, representing 2.4% of all cancers . Even with chemotherapy, the median survival for patients with pancreatic adenocarcinoma is 6 to 10 months. Few of the patients are diagnosed at a resectable stage (12%-20%) so many patients are candidates for palliation only.In this context, one of the most important symptoms is pain because it often affects both quality of life and survival.70 to 80 % of patients with Pancreatic cancer had abdominal pain at the time of diagnosis . Adequate pain control is therefore an essential component of care in these patients. In the initial phase, the pain is visceral, but with disease progression, somatic pain may occur, especially due to the peripancreatic invasion of neural structures or muscles. Standard analgesics such as Acetaminophen are ineffective and administration of opioids is frequently limited by side effects such as nausea, constipation, somnolence, addiction, confusion or respiratory depression, and failure in achieving adequate analgesia. In these situations, neurodestructive methods of celiac plexus with Absolute Alcohol associated to Bupivacaine involving the main pancreatic pain pathways, seem efficient. Alcohol causes the immediate precipitation of endoneural lipoproteins and mucoproteins within the celiac plexus, leading to the extraction of cholesterol and phospholipids from the neural membrane. To prevent severe transient pain after the procedure, Bupivacaine was injected before the Alcohol injection. Interest and importance of EUS-CPN is well established (safe, more effective than percutaneous or CT guided celiac plexus Neurolysis, significant reduction in pain and significant reduction of narcotics requirements) however the role and effect of Bupivacaine on the effectiveness of Neurolysis and lytic power of Alcohol has never been studied . Is it a synergistic effect ? Or an antagonistic effect by diluting Alcohol ? The Centre hospitalier de l'université de Montréal (CHUM) is currently the busiest EUS center in the world and has the largest experience with EUS-guided CPN. The CHUM also probably see more pancreatic cancers annually than any other center (more than 300 proven cases/year). There are no published reports of serious adverse events associated with this procedure and this has been the investigators experience as well. Patients may however experience some mild to moderate discomfort during the initial injection of the absolute ethanol solution, but this is usually short lived (less than 30 minutes in our experience). Therefore, Bupivacaine is currently injected before the Ethanol injection, however, local anesthetic was not used before the Phenol injection for example because it has been reported that Phenol has an immediate local anesthetic effect.

The investigators believe that, Bupivacaine has no effect and instead it dilutes the alcohol and then reduces the lytic power of Ethanol. This study was designed to test this hypothesis prospectively.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Neurolysis without Bupivacaine

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

Group Type: EXPERIMENTAL

Endoscopic ultrasound-guided celiax plexus neurolysis

Intervention Type: PROCEDURE

Endoscopic ultrasound-guided celiax plexus neurolysis

Neurolysis with Bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Endoscopic ultrasound-guided celiax plexus neurolysis

Intervention Type: PROCEDURE

Endoscopic ultrasound-guided celiax plexus neurolysis

Bupivacaine

Intervention Type: DRUG

Endoscopic ultrasound-guided celiax plexus neurolysis w/wo Bupivacaine

Interventions

Endoscopic ultrasound-guided celiax plexus neurolysis

Endoscopic ultrasound-guided celiax plexus neurolysis

Intervention Type: PROCEDURE

Bupivacaine

Endoscopic ultrasound-guided celiax plexus neurolysis w/wo Bupivacaine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

A Sahai

Professeur Titulaire de Médecine / Professor of Medicine Chef / Chief, Service de Gastroentérologie

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anand Sahai, M.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

CHUM

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 24415863 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24605017 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23539392 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22632946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21471704 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 19744638 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25132769 (View on PubMed)

Other Identifiers

CE 15.246

Identifier Type: -

Identifier Source: org_study_id