Adrian Diaz, MD
Fellow
University of Chicago
Chicago, Illinois, United States
Blase Polite, MD
Professor of Medicine
University of Chicago
Chicago, Illinois, United States
Michael J. Cavnar, MD, FACS (he/him/his)
Associate Professor of Surgery
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
James F. Pingpank, Jr., MD, FACS
Associate Professor of Surgery
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Ajay V. Maker, MD, FACS
Professor of Surgery and Chief, Division of Surgical Oncology
University of California San Francisco
San Francisco, California, United States
Paul J. Karanicolas, MD, PhD, FRCS(C), FACS
Professor of Surgery
University of Toronto
Toronto, Ontario, United States
Adam C. Yopp, MD, FACS
Professor of Surgery and Chief, Division of Surgical Oncology
University of Texas Southwestern
Dallas, Texas, United States
Skye C. Mayo, MD, MPH, FACS (he/him/his)
Professor of Surgery
Oregon Health and Science University
Portland, Oregon, United States
G. Paul Wright, MD, FACS, FSSO
Assistant Professor of Surgery
Michigan State University/Corewell Health West Cancer Center
Grand Rapids, Michigan, United States
Jashodeep Datta, MD, FACS (he/him/his)
Associate Professor of Surgery
University of Miami
Miami, Florida, United States
Michael I. D’Angelica, MD
Enid A. Haupt Endowed Chair in Surgery, Professor
Hepatopancreatobiliary Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, United States
Michael E. Lidsky, MD, FACS
Associate Professor of Surgery
Department of Surgery, Duke University Health System
Durham, North Carolina, United States
Ryan P. Merkow, MD, MS, FACS
Associate Professor of Surgery
University of Chicago
Chicago, Illinois, United States
Shale J. Mack, MD (he/him/his)
Resident
University of Chicago
Chicago, Illinois, United States
The use of hepatic arterial infusion pump (HAIP) chemotherapy for colorectal liver metastases and intrahepatic cholangiocarcinoma has increased expontentially over the past decade. Biliary sclerosis (BS) is one of the most concerning complications after HAIP, however, its occurence remains enigmatic and no modern multicenter hospital-level comparative safety data exists. Our objectives were to (1) characterize rates of BS, (2) identify predictors of BS, and (3) evaluate hospital-level variation of BS in the modern era.
Methods:
A retrospective cohort analysis was completed using the international HAI Consortium Research Network (HCRN) registry of patients treated with HAIP chemotherapy (2015-2024). A multivariable logistic regression model was utilized to assess predictors of BS and hierarchical logistic regression models were created to assess comparative hospital-level outlier status.
Results:
A total of 1,188 patients underwent HAIP placement from 36 centers, of which 94 patients (7.9%) developed BS requiring a stent. BS primarily occurred in the common hepatic/bile duct (70.0%) and was most commonly multifocal (57.0%). Median time from HAIP placement to BS was 261 days [IQR: 165, 434]. Rates of BS decreased over time (18.2% to 3.1%, p< 0.05). Independent predictors of BS included year of HAIP placement (OR 0.88, 95%CI 0.80-0.96), postoperative infection (OR 2.22, 95%CI 1.20-4.10), and FUDR dose (per 50mg) (OR 1.04, 95%CI 1.01-1.07). BS was not associated with aberrant arterial anatomy, prior chemotherapy, liver volume, pump placement indication, or hospital volume. At the hospital level, BS ranged from 0% to 20.8% (median 4.5%, IQR 0-11.8) and was not associated with hospital volume. After adjustment, 10 of 36 (27.8%) hospitals performed worse-than-expected, while 16 of 36 (44.4%) hospitals performed better-than-expected (Figure).
Conclusions:
In the modern era, BS occured in less than 10% of patients, has decreased over time, and is associated with FUDR dose and postoperative infection. Wide variation in BS was observed at the hospital level. More research is needed to understand modifiable clinical predictors of BS and develop effective risk reduction strategies.