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Proffered Paper session - Gastrointestinal tumours, colorectal 2

384O - Laparoscopic versus open hemihepatectomy: The ORANGE II PLUS multicenter randomized controlled trial

Date

20 Sep 2021

Session

Proffered Paper session - Gastrointestinal tumours, colorectal 2

Presenters

Robert Fichtinger

Citation

Annals of Oncology (2021) 32 (suppl_5): S530-S582. 10.1016/annonc/annonc698

Authors

R.S. Fichtinger1, L. Aldrighetti2, R. Troisi3, M. Abu Hilal4, R. Sutcliffe5, M. Besselink6, S. Aroori7, K. Menon8, B. Edwin9, M. D'Hondt10, V. Lucidi11, F. Ulmer12, R. Díaz-Nieto13, F. Ratti2, C. Kümmerli14, L. Brandts15, S. Pugh16, Z. Eminton17, J. Primrose18, R. van Dam19

Author affiliations

  • 1 Surgery, Maastricht University Medical Center (MUMC), 6202 AZ - Maastricht/NL
  • 2 Surgery, IRCCS San Raffaele Hospital, Milan/IT
  • 3 Surgery, Ghent University Hospital, Ghent/BE
  • 4 Surgery, University Hospital Southampton NHS Foundation Trust, Southampton/GB
  • 5 Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham/GB
  • 6 Surgery, Amsterdam University Medical Center (UMC) locatie Academic Medical Center (AMC), 1105AZ - Amsterdam/NL
  • 7 Surgery, University Hospitals Plymouth NHS Foundation Trust, Plymouth/GB
  • 8 Surgery, King’s College Hospital NHS Foundation Trust, London/GB
  • 9 Surgery, Oslo University Hospital, Oslo/NO
  • 10 Surgery, Groeninge Hospital, Kortrijk/BE
  • 11 Digestive Surgery, Hepatobiliary Surgery & Liver Transplantation, Erasme University Hospital-(Universite Libre de Bruxelles), 1070 - Brussels/BE
  • 12 Surgery, University Hospital RWTH Aachen, Aachen/DE
  • 13 Surgery, Aintree University Hospital NHS Foundation Trust, Liverpool/GB
  • 14 Surgery, Southampton University Hospital NHS Foundation Trust, Southampton/GB
  • 15 Statistics, Maastricht University Medical Center+, Maastricht/NL
  • 16 Medical Oncology Department, University of Southampton, SO17 1BJ - Southampton/GB
  • 17 Southampton Clinical Trials Unit, Southampton University Hospital NHS Foundation Trust, Southampton/GB
  • 18 Surgery, Southampton General Hospital Southampton University Hospitals NHS Trust, SO16 6YD - Southampton/GB
  • 19 Surgery, Maastricht University Medical Center, Maastricht/NL
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Resources

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Abstract 384O

Background

Surgical resection forms the mainstay of curative treatment for cancers involving the liver. The laparoscopic approach to major liver resections is increasingly being performed. Randomized evidence to show superiority of laparoscopic (LH) compared to open hemihepatectomy (OH) for perioperative and oncological outcomes is lacking.

Methods

Patients undergoing hemihepatectomy for accepted indications (principally known or suspected cancer) were randomized 1:1 to either LH or OH in 16 European centers. Patients and ward personnel were blinded until postoperative day 4. The primary endpoint was time to functional recovery (TFR). The definition included being independently mobile with adequate oral intake and normalizing liver function. Secondary outcomes included length of hospital stay (LOS), postoperative 90-day morbidity, 90-day mortality, resection margin status and 3-year survival. All analyses were by intention to treat (ITT).

Results

179 eligible patients were randomly assigned to LH and 173 to OH between October 2013 and January 2019. 135 (75%) of 179 patients in the LH group and 142 (82%) of 173 patients in the OH group had cancer: 162 colorectal liver metastases (CRLM), 47 hepatoma, 47 cholangiocarcinoma, 21 other metastases. Primary ITT analysis included 327 patients (LH 164 vs OH 163) and demonstrated a significant reduction in TFR: LH 4 days (IQR 2-6) vs OH 5 days (IQR 3-7), P< 0.001. LOS was similarly different: LH 5 days (IQR 2-8) vs OH 6 days (IQR 4-8), P= 0.002. In the LH group 15% (24/164) of patients experienced complications > Clavien-Dindo IIIa within 90 days of surgery vs 18% (30/163) in the OH group, P= 0.36. There were 5 deaths (3.0%) within 90 days of surgery in the LH group vs 5 (3.1%) in the OH group, P= 0.99. For all cancers, resection margins ≥1 mm were attained for 107/133 (81%) patients in the LH group vs 121/138 (88%) patients in the OH group (OR 1.73, 99% CI 0.72-4.14, P= 0.11). At a median follow-up of 37 months (IQR 24-50 months) 3-year survival rate was 58% for LH vs 65% for OH (HR 1.16, 99% CI 0.68-1.98, P=0.49).

Conclusions

LH is superior to OH in terms of TFR and LOS. No significant differences in oncological outcomes were observed but follow-up continues to permit a mature survival analysis.

Clinical trial identification

NCT01441856.

Editorial acknowledgement

Legal entity responsible for the study

Maastricht University Medical Center.

Funding

Maastricht University Medical Center+ Cancer Research United Kingdom European Association of Endoscopic Surgery Paticipating centers.

Disclosure

All authors have declared no conflicts of interest.

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