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SAGES/AHPBA guidelines for the use of microwave and radiofrequency liver ablation for the surgical treatment of hepatocellular carcinoma or colorectal liver metastases less than 5 cm

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Abstract

Background

Primary hepatocellular carcinoma (HCC) and colorectal liver metastases (CRLM) represent the liver’s two most common malignant neoplasms. Liver-directed therapies such as ablation have become part of multidisciplinary therapies despite a paucity of data. Therefore, an expert panel was convened to develop evidence-based recommendations regarding the use of microwave ablation (MWA) and radiofrequency ablation (RFA) for HCC or CRLM less than 5 cm in diameter in patients ineligible for other therapies.

Methods

A systematic review was conducted for six key questions (KQ) regarding MWA or RFA for solitary liver tumors in patients deemed poor candidates for first-line therapy. Subject experts used the GRADE methodology to formulate evidence-based recommendations and future research recommendations.

Results

The panel addressed six KQs pertaining to MWA vs. RFA outcomes and laparoscopic vs. percutaneous MWA. The available evidence was poor quality and individual studies included both HCC and CRLM. Therefore, the six KQs were condensed into two, recognizing that these were two disparate tumor groups and this grouping was somewhat arbitrary. With this significant limitation, the panel suggested that in appropriately selected patients, either MWA or RFA can be safe and feasible. However, this recommendation must be implemented cautiously when simultaneously considering patients with two disparate tumor biologies. The limited data suggested that laparoscopic MWA of anatomically more difficult tumors has a compensatory higher morbidity profile compared to percutaneous MWA, while achieving similar overall 1-year survival. Thus, either approach can be appropriate depending on patient-specific factors (very low certainty of evidence).

Conclusion

Given the weak evidence, these guidelines provide modest guidance regarding liver ablative therapies for HCC and CRLM. Liver ablation is just one component of a multimodal approach and its use is currently limited to a highly selected population. The quality of the existing data is very low and therefore limits the strength of the guidelines.

Executive summary

AbstractSection Background

The multidisciplinary management of both primary hepatocellular carcinoma (HCC) and colorectal liver metastases (CRLM) may include liver-directed therapies as part of treatment algorithms; these algorithms focus heavily on control of liver-specific disease as in many cases this serves as a proxy for long-term survival. Hepatectomy is the primary treatment option in patients who can tolerate resection for both HCC and CRLM. Liver-directed therapies include arterial embolization, stereotactic body radiation therapy, and liver ablation. Over the last several decades, microwave ablation (MWA) and radiofrequency ablation (RFA) of liver tumors have been used in high-risk patients unfit for surgical intervention or tumors not amenable to local control with other therapies. As ablation is an evolving technology, outcomes data are primarily reported in liver tumors less than 3 cm in diameter, while data for liver tumors greater than 3 cm are limited for both HCC and CRLM. The authors sought to perform a systematic review of the existing data to assess for meaningful conclusions. Therefore, a multidisciplinary expert panel was convened to develop evidence-based recommendations to support clinicians, patients, and others regarding the role of liver ablation in the treatment of HCC and CRLM up to 5 cm in diameter.

AbstractSection Methods

A systematic review was conducted for six key questions (KQ) regarding the use of either MWA or RFA for solitary HCC or CRLM. Due to the paucity of evidence available, HCC and CRLM less than 5 cm in diameter were combined into two final KQs which were used to develop recommendations. Evidence-based recommendations were formulated using the GRADE methodology by subject matter experts. Additionally, the panel developed recommendations for future research.

AbstractSection Interpretation of strong and conditional recommendations

All guideline recommendations were assigned “conditional” recommendations. These were based on the GRADE approach. The words “the guideline panel suggests” were used for conditional recommendations.

AbstractSection Key questions addressed by these guidelines
  1. 1.

    Should MWA (laparoscopic or open) vs. RFA (laparoscopic or open) be used for HCC or CRLM less than 5 cm ineligible for other therapies?

  2. 2.

    Should laparoscopic MWA vs. percutaneous MWA be used for HCC and/or CRLM less than 5 cm ineligible for other therapies?

AbstractSection Recommendations
  1. 1.

    Should MWA (laparoscopic or open) vs. RFA (laparoscopic or open) be used for HCC or CRLM less than 5 cm ineligible for other therapies?

    The panel suggests MWA and RFA are both safe and feasible. There was insufficient evidence to recommend one modality over another in terms of oncologic outcomes (conditional recommendation, very low certainty of evidence).

  2. 2.

    Should laparoscopic MWA vs. percutaneous MWA be used for HCC and/or CRLM less than 5 cm ineligible for other therapies?

    The panel suggests that either ablative approach achieves similar overall outcomes, albeit through distinct patterns. The laparoscopic approach obtained better local control and the percutaneous approach had fewer morbidities while obtaining similar overall 1-year survival (conditional recommendation, very low certainty of evidence).

AbstractSection How to use these guidelines

The aim of these guidelines is to assist surgeons and physicians in making management decisions for patients with HCC or CRLM. Given that the evidence for this guideline was based on very low certainty evidence, these guidelines should be applied with caution. They are also intended to provide education, inform advocacy, and describe future areas for research. The guidelines are not meant to mandate a particular approach or strategy given the lack of evidence and intricacies of the healthcare environment, individual patient needs, comorbidities, and surgeon experience. Specific situations require adjustment of treatment plans to suit the needs and priorities of the individual patient. Finally, since the guidelines take a patient-centered approach, patients can use these guidelines as a source of information and for discussion with their physicians.

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Acknowledgements

We would like to thank Sarah Colón, the SAGES senior program coordinator, Holly Ann Burt, the SAGES librarian, and the SAGES guidelines committee members for their help with the creation of this guideline.

Disclaimer

Clinical practice guidelines are intended to indicate the best available approach to medical conditions as established by a systematic review of available data and expert opinion. The approach suggested may not necessarily be the only acceptable approach given the complexity of the healthcare environment. These guidelines are intended to accommodate the numerous variables inherent to the treatment of an individual patient. Treatment strategy must be tailored to the patient on case-by-case basis. These guidelines are applicable to all physicians who are appropriately credentialed regardless of specialty at institutions with appropriate expertise in both laparoscopic and percutaneous approaches.

These guidelines are developed under the auspices of SAGES and AHPBA, the guidelines committee, and approved by the Board of Governors of both societies. The recommendations of each guideline undergo multidisciplinary review and are considered valid at the time of production based on the data available. New developments in medical research and practice pertinent to each guideline are reviewed, and guidelines are periodically updated.

Funding

This work was funded by Society of American Gastrointestinal and Endoscopic Surgeons.

Author information

Authors and Affiliations

  1. Department of Surgery, Indiana University School of Medicine, 545 Barnhill Dr, EH541, Indianapolis, IN, 46202, USA

    Eugene P. Ceppa, Jake Whiteside & Rebecca Dirks

  2. Hiram C. Polk, Jr. Department of Surgery, University of Louisville School of Medicine, Louisville, KY, USA

    Amelia T. Collings

  3. Department of Surgery, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA

    Moustafa Abdalla

  4. Department of Surgery, Texas Tech University Health Sciences Center, Lubbock, TX, USA

    Edwin Onkendi

  5. Department of Surgery, William Beaumont Army Medical Center, El Paso, TX, USA

    Daniel W. Nelson

  6. King George’s Medical University, Lucknow, India

    Ahmad Ozair

  7. UCSF East Bay Department of Surgery, UCSF, Oakland, CA, USA

    Emily Miraflor

  8. Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, India

    Faique Rahman

  9. Division of Surgical Oncology, Department of Surgery, Emory University Winship Cancer Institute, Atlanta, GA, USA

    Mihir M. Shah

  10. Department of Surgery, Brown University, Providence, RI, USA

    Subhashini Ayloo

  11. Department of Surgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA

    Sunjay S. Kumar

  12. School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada

    Mohammed T. Ansari

  13. Digestive Health Institute, AdventHealth, Tampa, FL, USA

    Iswanto Sucandy

  14. Department of Surgery A, Sfax Medical School, Sfax, Tunisia

    Kchaou Ali

  15. Department of Surgery, Naval Medical Center Portsmouth, Portsmouth, VA, USA

    Sam Douglas

  16. Division of Surgical Oncology, Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA

    Patricio M. Polanco

  17. Department of Surgery, Brooke Army Medical Center, San Antonio, TX, USA

    Timothy J. Vreeland

  18. Department of Surgery, Mission Health Care System, Asheville, NC, USA

    Joseph Buell

  19. University of Manibota, Winnepeg, Canada

    Ahmed M. Abou-Setta

  20. Department of Surgery, University of Florida, Jacksonville, FL, USA

    Ziad Awad

  21. Department of General Surgery, Cleveland Clinic, Cleveland, OH, USA

    Choon Hyuck Kwon

  22. Department of Surgery, Atrium Health, Charlotte, NC, USA

    John B. Martinie

  23. Department of Surgery, Chicago Medical School, Rosalind Franklin University, Chicago, IL, USA

    Fabio Sbrana

  24. Department of Surgery, Long Island Jewish Medical Center, Northwell Health, Great Neck, NY, USA

    Aurora Pryor

  25. Department of Surgery, University of Chicago, Chicago, IL, USA

    Bethany J. Slater

  26. Department of Surgery, Ochsner Clinic, Jefferson, LA, USA

    William Richardson

  27. TCU/UNTHSC School of Medicine, Fort Worth, TX, USA

    Rohan Jeyarajah

  28. Department of Surgery, University of California, San Francisco, CA, USA

    Adnan Alseidi

Authors
  1. Eugene P. Ceppa
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  30. Adnan Alseidi
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Corresponding author

Correspondence to Eugene P. Ceppa.

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Disclosures

The following authors disclosed ties: Edwin Onkendi is an investor in ROMtech Modern Technology for Rehabilitation. Mihir M. Shah has received consulting fees from Intuitive. Rebecca Dirks owns publicly traded stock from Johnson & Johnson. Patricio M. Polanco has received the Eugene Frenkel Scholar Award from the Simmons Cancer Center at UT Southwestern Medical Center and consulting fees from Pallisade Bio Inc. He is a participant on a data safety monitoring or advisory board at the Simmons Cancer Center. Timothy J. Vreeland has received consulting fees from Lumabridge. Choon Hyuck Kwon has received consulting fees from Medtronic and Fujifilm, payment or honoraria from Medtronic and Fujifilm, and travel support from Fujifilm. Aurora Pryor has received payment or honoraria from Stryker, Gore, and Medtronic and payment for expert testimony. She holds leadership roles with SAGES, the Fellowship Council, and SAGES Ingenuity. Bethany J. Slater has received consulting fees from Hologic and Cook Medical and holds leadership role with SAGES. Rohan Jeyarajah has received consulting fees from Sirtex, AngioDynamics, and Ethicon, payment or honoraria from Sirtex, and travel support from Methodist Health System. He is a participant on a data safety monitoring or advisory board at AngioDynamics and holds leadership roles with AHPBA and ABS. Eugene P. Ceppa, Amelia Collings, Moustafa Abdalla, Daniel W. Nelson, Ahmad Ozair, Emily Miraflor, Faique Rahman, Jake Whiteside, Subhashini Ayloo, Sunjay S. Kumar, Mohammed T. Ansari, Iswanto Sucandy, Kchaou Ali, Sam Douglas, Joseph Buell, Ahmed M. Abou-Setta, Ziad Awad, John B. Martinie, Fabio Sbrana, William Richardson, and Adnan Alseidi have no financial ties or conflicts of interest to disclose.

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Ceppa, E.P., Collings, A.T., Abdalla, M. et al. SAGES/AHPBA guidelines for the use of microwave and radiofrequency liver ablation for the surgical treatment of hepatocellular carcinoma or colorectal liver metastases less than 5 cm. Surg Endosc 37, 8991–9000 (2023). https://doi.org/10.1007/s00464-023-10468-1

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