Dataset Information

Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine.

ABSTRACT:

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

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

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

This randomized trial is designed to assess whether bupivacaine is of any value during EUS-CPN.

SUBMITTER: Esmail E

PROVIDER: S-EPMC10486028 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine.

Esmail Eslam E Paquin Sarto C SC Sahai Anand V AV

Trials 20230908 1

<h4>Background</h4>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.<h4>Study design</h4>Single center, randomized, double blind controlled trial of EUS-CPN with and without bupivacaine in patie ...[more]

PMID: 37684697

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Project description:Background/Aims:In most instances of abdominal pain associated with pancreatic cancer, pain may become refractory to increasing doses of narcotics. Celiac plexus neurolysis represents an option; however, altered celiac plexus anatomy may render this treatment infeasible or ineffective, where splanchnic nerve neurolysis may represent another option. This study aimed to investigate the outcomes of splanchnic neurolysis in pancreatic cancer patients not responsive to celiac plexus neurolysis. Patients and Methods:Among all 84 patients who underwent celiac plexus neurolysis for pancreatic cancer pain during the study period, 34 patients did not respond and underwent splanchnic nerve neurolysis under fluoroscopic guidance and thus included in this retrospective study. Stage IV, III, and II disease was present in 38.2%, 47.1%, and 14.7% of the patients. During the study, 88.2% were receiving chemotherapy, whereas none were on radiotherapy. Data for daily narcotic dose equivalents and Visual Analogue Scale (VAS) scores during outpatient visits at baseline, 2 weeks, 2 months, and 3 months were extracted. Results:Pain response rates were 76.5%, 84.4%, and 71.0%, at 2 weeks, 2 months, and 3 months, respectively. A significant and dramatic reduction was seen in VAS scores at 2 weeks (2.8±1.2 versus 6.3±1.1, p<0.001), and this significant decline was maintained for 3 months. Similarly, a significant and dramatic reduction was seen in daily narcotic need at 2 weeks (20.8±32.9 versus 93.4±86.2 mg, p<0.001), which was also maintained during the 3-month follow-up. The procedure was generally well tolerated. Conclusion:Findings of this study suggest that splanchnic neurolysis represents a durable and effective option for pain control in pancreatic cancer patients in whom the neurolysis of the celiac plexus is ineffective. However, these conclusions refer to only preliminary single-center results in a selected patient group; thus, further large studies are warranted.

Project description:Long term prognosis and 5-year survival for pancreatic adenocarcinoma (PDAC) remains suboptimal. Endoscopic ultrasound (EUS) guided RFA (EUS-RFA) is an emerging technology and limited data exist regarding safety and long-term outcomes. The aim of this study is to report safety-profile, feasibility and outcomes of EUS-RFA for advanced PDAC. Prospective review of patients with diagnosis of locally-advanced or metastatic PDAC undergoing EUS-RFA between October 2016 to March 2018 with long-term follow up (> 30 months). Study patients underwent a total of 1-4 RFA sessions. All patients were enrolled in longitudinal cohort study and received standard of care chemotherapy. 10 patients underwent EUS-RFA. Location of the lesions was in the head(4), neck(2), body(2), and tail(2). 22 RFA sessions were performed with a range of 1-4 sessions per patient. There were no major adverse events (bleeding, perforation, infection, pancreatitis) in immediate (up to 72 h) and short-term follow up (4 weeks). Mild worsening of existing abdominal pain was noted during post-procedure observation in 12/22 (55%) of RFA treatments. Follow-up imaging demonstrated tumor progression in 2 patients, whereas tumor regression was noted in 6 patients (> 50% reduction in size in 3 patients). Median survival for the cohort was 20.5 months (95% CI, 9.93-42.2 months). Currently, 2 patients remain alive at 61 and 81 months follow-up since initial diagnosis. One patient had 3 cm PDAC with encasement of the portal confluence, abutment of the celiac axis, common hepatic and superior mesenteric artery. This patient had significant reduction in tumor size and underwent standard pancreaticoduodenectomy. In our experience, EUS-RFA was safe, well-tolerated and could be concurrently performed with standard chemotherapy. In this select cohort, median survival was improved when compared to published survival based upon SEER database and clinical trials. Future prospective trials are needed to understand the role of EUS-RFA in overall management of PDAC.

Dataset Information

Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine.

Background

Study design

Discussion

Conclusion

Publications

Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine.

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