Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine.
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
08 Sep 2023
08 Sep 2023
Historique:
received:
17
11
2022
accepted:
28
06
2023
medline:
11
9
2023
pubmed:
9
9
2023
entrez:
8
9
2023
Statut:
epublish
Résumé
Pancreatic cancer is a devastating disease with less than 5% 5-year survival. Inoperable patients often present with pain. Randomized controlled trial have shown that endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) improves pain control. It is usually performed by injecting bupivacaine followed by absolute alcohol around the celiac axis. Single center, randomized, double blind controlled trial of EUS-CPN with and without bupivacaine in patients with inoperable malignancy (pancreatic or other) involving the celiac plexus. The study was approved by research ethics board with approval number of 2022-9969, 21.151 and registered on ClinicalTrials.gov (NCT04951804). We hypothesize that bupivacaine is superfluous and may actually reduce pain control by diluting the neurolytic effect of alcohol. Bupivacaine is also potentially dangerous in that it may produce serious adverse events such as arrythmias and cardiac arrest if inadvertently injected intravascularly. This randomized trial is designed to assess whether bupivacaine is of any value during EUS-CPN.
Sections du résumé
BACKGROUND
BACKGROUND
Pancreatic cancer is a devastating disease with less than 5% 5-year survival. Inoperable patients often present with pain. Randomized controlled trial have shown that endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) improves pain control. It is usually performed by injecting bupivacaine followed by absolute alcohol around the celiac axis.
STUDY DESIGN
METHODS
Single center, randomized, double blind controlled trial of EUS-CPN with and without bupivacaine in patients with inoperable malignancy (pancreatic or other) involving the celiac plexus. The study was approved by research ethics board with approval number of 2022-9969, 21.151 and registered on ClinicalTrials.gov (NCT04951804).
DISCUSSION
CONCLUSIONS
We hypothesize that bupivacaine is superfluous and may actually reduce pain control by diluting the neurolytic effect of alcohol. Bupivacaine is also potentially dangerous in that it may produce serious adverse events such as arrythmias and cardiac arrest if inadvertently injected intravascularly.
CONCLUSION
CONCLUSIONS
This randomized trial is designed to assess whether bupivacaine is of any value during EUS-CPN.
Identifiants
pubmed: 37684697
doi: 10.1186/s13063-023-07487-7
pii: 10.1186/s13063-023-07487-7
pmc: PMC10486028
doi:
Substances chimiques
Bupivacaine
Y8335394RO
Ethanol
3K9958V90M
Banques de données
ClinicalTrials.gov
['NCT04951804']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
576Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
Références
Rawla P, Sunkara T, Gaduputi V. Epidemiology of pancreatic cancer: global trends, etiology and risk factors. World J Oncol. 2019;10(1):10–27.
doi: 10.14740/wjon1166
pubmed: 30834048
pmcid: 6396775
Reynolds RB, Folloder J. Clinical management of pancreatic cancer. J Adv Pract Oncol. 2014;5(5):356–64.
pubmed: 26114016
pmcid: 4457174
Balaban EP, Mangu PB, Khorana AA, Shah MA, Mukherjee S, Crane CH, et al. Locally advanced, unresectable pancreatic cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2016;34(22):2654–68.
doi: 10.1200/JCO.2016.67.5561
pubmed: 27247216
Wyse JM, Carone M, Paquin SC, et al. Randomized, double-blind, controlled trial of early endoscopic ultrasound-guided celiac plexus neurolysis to prevent pain progression in patients with newly diagnosed, painful, inoperable pancreatic cancer. J Clin Oncol. 2011;29(26):3541–6.
doi: 10.1200/JCO.2010.32.2750
pubmed: 21844506
Levy MJ, Gleeson FC, Topazian MD, Fujii-Lau LL, Enders FT, et al. Combined celiac ganglia and plexus neurolysis shortens survival, without benefit, vs plexus neurolysis alone. Clin Gastroenterol Hepatol. 2019;17(4):728–738.e9.
doi: 10.1016/j.cgh.2018.08.040
pubmed: 30217513
Lou S. Endoscopic ultrasound-guided celiac plexus neurolysis to alleviate intractable pain caused by advanced pancreatic cancer. Surg Laparosc Endosc Percutan Tech. 2019;29(6):472–5.
doi: 10.1097/SLE.0000000000000683
pubmed: 31107855
Wyse JM, Battat R, Sun S, et al. Practice guidelines for endoscopic ultrasound-guided celiac plexus neurolysis. Endosc Ultrasound. 2017;6(6):369–75.
doi: 10.4103/eus.eus_97_17
pubmed: 29251270
pmcid: 5752758
Eledjam JJ, de la Coussaye JE, Bassoul B, Brugada J. Mécanismes de la toxicité cardiaque de la bupivacaïne. Annales Françaises d’Anesthésie et de Réanimation. 1988;7(3):204–10. https://doi.org/10.1016/S0750-7658(88)80112-6 .
doi: 10.1016/S0750-7658(88)80112-6
pubmed: 3408033
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
doi: 10.1136/bmj.e7586
pubmed: 23303884
pmcid: 3541470
Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010;71(3):446–54.
doi: 10.1016/j.gie.2009.10.027
pubmed: 20189503