Safety of adjuvant brachytherapy combined with external beam radiotherapy for proximal bile duct pR1 in perihilar cholangiocarcinoma: a prospective registration study.
11 affiliations
- 1Department of Digestive Diseases, Transplantation and General Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen, 2100, Denmark. [email protected].
- 2Hepatic Malignancy Surgical Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, 2100, Denmark. [email protected].
- 3Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, 2100, Denmark.
- 4Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, 2730, Denmark.
- 5Department of Oncology, Aarhus University Hospital, Aarhus, 8200, Denmark.
- 6Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, 8200, Denmark.
- 7Department of Digestive Diseases, Transplantation and General Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen, 2100, Denmark.
- 8Hepatic Malignancy Surgical Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, 2100, Denmark.
- 9Department of Oncology, Clinical Cancer Research Centre, Aalborg University Hospital, Aalborg, 9000, Denmark.
- 10Department of Clinical Medicine, Aalborg University, Aalborg, 9000, Denmark.
- 11Department of Clinical Medicine, University of Copenhagen, Copenhagen, 2100, Denmark.
Abstract
Background
Microscopic residual disease (pR1) following resection of perihilar cholangiocarcinoma (pCCA) is associated with high recurrence rates. Adjuvant brachytherapy (BT) combined with external beam radiotherapy (EBRT) is proposed to improve local control; however, contemporary data on treatment-related toxicity are scarce.Methods
This prospective registration study included patients with pCCA and isolated pR1 at the proximal bile duct (PBD) margin treated with adjuvant BT and EBRT between January 2017 and December 2021. Primary endpoints were radiation-induced biliary strictures, and severe treatment-related adverse events (TRAEs). Secondary endpoints were overall survival (OS), disease-free survival (DFS) and local recurrence.Results
Eight patients were eligible of whom six received treatment. Median time from surgery to BT was 39.5 days, with a median follow up of 35.5 months. Early severe TRAEs were infrequent (n = 2). Radiation-induced biliary strictures occurred in four patients and late severe TRAEs were common (n = 16), predominatly by recurrent cholangitis, resulting in one death (n = 1). Four developed recurrence, all at distant sites and no local recurrences. Median DFS was 28.6 months (IQR 10.9-53.5) and median OS 34.3 months (IQR 19.4-39.9).Conclusion
Adjuvant BT combined with EBRT was associated with high rates of severe late TRAEs in resected pCCA. Despite absence of local recurrence, these findings raise concerns regarding routine use outside clinical trials.
Related
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- Long-Term Outcomes of a Multidisciplinary Treatment Strategy Using Neoadjuvant Gemcitabine Plus S-1 Based on Anatomical Resectability Classification and Lymph Node Status in Patients with Perihilar Cholangiocarcinoma
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- Preoperative sustained C-reactive protein elevation shortens patient survival after liver resection for perihilar cholangiocarcinoma : A retrospective cohort study with propensity score analyses
BibTeX
@article{alsaffar2026safety,
title = {{Safety of adjuvant brachytherapy combined with external beam radiotherapy for proximal bile duct pR1 in perihilar cholangiocarcinoma: a prospective registration study.}},
author = {Hasan Ahmad Al-Saffar and Henrik Roed and Marianne Feen Rønjom and Britta Weber and Christoph Tschuor and Peter Nørgaard Larsen and Flemming Kjær-Kristoffersen and Morten Ladekarl and Hans-Christian Pommergaard},
journal = {Langenbeck's archives of surgery},
year = {2026},
month = aug,
doi = {10.1007/s00423-026-04180-6},
url = {https://europepmc.org/article/MED/42970032},
note = {CC BY},
}
RIS
TY - JOUR
TI - Safety of adjuvant brachytherapy combined with external beam radiotherapy for proximal bile duct pR1 in perihilar cholangiocarcinoma: a prospective registration study.
AU - Hasan Ahmad Al-Saffar
AU - Henrik Roed
AU - Marianne Feen Rønjom
AU - Britta Weber
AU - Christoph Tschuor
AU - Peter Nørgaard Larsen
AU - Flemming Kjær-Kristoffersen
AU - Morten Ladekarl
AU - Hans-Christian Pommergaard
PY - 2026
DA - 2026/08/05
JO - Langenbeck's archives of surgery
DO - 10.1007/s00423-026-04180-6
UR - https://europepmc.org/article/MED/42970032
AB - Background Microscopic residual disease (pR1) following resection of perihilar cholangiocarcinoma (pCCA) is associated with high recurrence rates. Adjuvant brachytherapy (BT) combined with external beam radiotherapy (EBRT) is proposed to improve local control; however, contemporary data on treatment-related toxicity are scarce.Methods This prospective registration study included patients with pCCA and isolated pR1 at the proximal bile duct (PBD) margin treated with adjuvant BT and EBRT between January 2017 and December 2021. Primary endpoints were radiation-induced biliary strictures, and severe treatment-related adverse events (TRAEs). Secondary endpoints were overall survival (OS), disease-free survival (DFS) and local recurrence.Results Eight patients were eligible of whom six received treatment. Median time from surgery to BT was 39.5 days, with a median follow up of 35.5 months. Early severe TRAEs were infrequent (n = 2). Radiation-induced biliary strictures occurred in four patients and late severe TRAEs were common (n = 16), predominatly by recurrent cholangitis, resulting in one death (n = 1). Four developed recurrence, all at distant sites and no local recurrences. Median DFS was 28.6 months (IQR 10.9-53.5) and median OS 34.3 months (IQR 19.4-39.9).Conclusion Adjuvant BT combined with EBRT was associated with high rates of severe late TRAEs in resected pCCA. Despite absence of local recurrence, these findings raise concerns regarding routine use outside clinical trials.
SN - 1435-2443
SN - 1435-2451
ER -