Document Type

Article

Publication Date

5-7-2026

Comments

This article is the author’s final published version in eClinicalMedicine, Volume 95, 2026, Article number 103968.

The published version is available at https://doi.org/10.1016/j.eclinm.2026.103968. Copyright © 2026 The Author(s).

 

Abstract

BACKGROUND: Retroperitoneal pain syndrome seen in pancreatic cancer is a major clinical challenge. Celiac plexus radiosurgery, a new palliative technique for retroperitoneal pain syndrome, decreased pain levels in a phase II study. Here Health-Related Quality of Life (HRQOL) outcomes are reported.

METHODS: Evaluable patients, who were enrolled between January 2018 and December 2021, in an international single-arm Phase II ethics-approved study (NCT03323489), were included. The pre-specified secondary endpoint-change in HRQOL from baseline to 3- and 6-weeks post-treatment, was measured by the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) version 4 questionnaire. Mean change was deemed clinically significant (CS) if the lower bound of the 95% confidence interval was above the predefined minimal clinically important difference (MCID) for that outcome.

FINDINGS: Of 90 evaluable patients, 51 (57%) and 44 (49%) had HRQOL FACT-Hep scores available at 3- and 6-weeks, compared to baseline. The majority of patients had pancreatic cancer (90%) and mean daily intravenous morphine equivalent consumption was 35.9 mg (SD 67.6).The mean increase of FACT-Hep total score from baseline was 9.3 points at 3-weeks (p = 0.0017) and 19.6 points at 6-weeks (p < 0.0001, 95% CI 13-26.3), representing a statistically significant (SS) 22% improvement from baseline, with CS demonstrated at 6-weeks. A sensitivity analysis, imputing no change from baseline in patients with missing data, demonstrated similar results. On multivariable analysis, lower baseline opioid use and baseline FACT-Hep scores were associated with an increased change in FACT-Hep from baseline to 3-weeks.

INTERPRETATION: Celiac plexus radiosurgery was associated with a SS improvement in HRQOL amongst patients with retroperitoneal pain at 3-weeks, and a SS and CS improvement at 6-weeks post intervention.

FUNDING: This study received major financial support provided by Gateway for Cancer Research (G-17-100), additional support was provided from the Israel Cancer Association (20170128 and 20181272).

Creative Commons License

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.

PubMed ID

42163973

Language

English

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