Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial

Robert S Fichtinger; Luca A Aldrighetti; Mohammed Abu Hilal; Roberto I Troisi; Robert P Sutcliffe; Marc G Besselink; Somaiah Aroori; Krishna V Menon; Bjørn Edwin; Mathieu D'Hondt; Valerio Lucidi; Tom F Ulmer; Rafael Díaz-Nieto; Zahir Soonawalla; Steve White; Gregory Sergeant; Bram Olij; Francesca Ratti; Christoph Kuemmerli; Vincenzo Scuderi; Frederik Berrevoet; Aude Vanlander; Ravi Marudanayagam; Pieter Tanis; Maxime J L Dewulf; Cornelis H C Dejong; Zina Eminton; Merel L Kimman; Lloyd Brandts; Ulf P Neumann; Åsmund A Fretland; Siân A Pugh; Gerard J P van Breukelen; John N Primrose; Ronald M van Dam; ORANGE II PLUS Collaborative

doi:10.1200/JCO.23.01019

Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial

Robert S Fichtinger
, Luca A Aldrighetti
, Mohammed Abu Hilal
, Roberto I Troisi
, Robert P Sutcliffe
, Marc G Besselink
, Somaiah Aroori
, Krishna V Menon
, Bjørn Edwin
, Mathieu D'Hondt
, Valerio Lucidi
, Tom F Ulmer
, Rafael Díaz-Nieto
, Zahir Soonawalla
, Steve White
, Gregory Sergeant
, Bram Olij
, Francesca Ratti
, Christoph Kuemmerli
, Vincenzo Scuderi

Frederik Berrevoet, Aude Vanlander, Ravi Marudanayagam, Pieter Tanis, Maxime J L Dewulf, Cornelis H C Dejong, Zina Eminton, Merel L Kimman, Lloyd Brandts, Ulf P Neumann, Åsmund A Fretland, Siân A Pugh, Gerard J P van Breukelen, John N Primrose, Ronald M van Dam^*, ORANGE II PLUS Collaborative

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

PURPOSE: To compare outcomes after laparoscopic versus open major liver resection (hemihepatectomy) mainly for primary or metastatic cancer. The primary outcome measure was time to functional recovery. Secondary outcomes included morbidity, quality of life (QoL), and for those with cancer, resection margin status and time to adjuvant systemic therapy. PATIENTS AND METHODS: This was a multicenter, randomized controlled, patient-blinded, superiority trial on adult patients undergoing hemihepatectomy. Patients were recruited from 16 hospitals in Europe between November 2013 and December 2018. RESULTS: Of the 352 randomly assigned patients, 332 patients (94.3%) underwent surgery (laparoscopic, n = 166 and open, n = 166) and comprised the analysis population. The median time to functional recovery was 4 days (IQR, 3-5; range, 1-30) for laparoscopic hemihepatectomy versus 5 days (IQR, 4-6; range, 1-33) for open hemihepatectomy (difference, -17.5% [96% CI, -25.6 to -8.4]; < .001). There was no difference in major complications (laparoscopic 24/166 [14.5%] open 28/166 [16.9%]; odds ratio [OR], 0.84; = .58). Regarding QoL, both global health status (difference, 3.2 points; < .001) and body image (difference, 0.9 points; < .001) scored significantly higher in the laparoscopic group. For the 281 (84.6%) patients with cancer, R0 resection margin status was similar (laparoscopic 106 [77.9%] open 122 patients [84.1%], OR, 0.60; = .14) with a shorter time to adjuvant systemic therapy in the laparoscopic group (46.5 days 62.8 days, hazard ratio, 2.20; = .009). CONCLUSION: Among patients undergoing hemihepatectomy, the laparoscopic approach resulted in a shorter time to functional recovery compared with open surgery. In addition, it was associated with a better QoL, and in patients with cancer, a shorter time to adjuvant systemic therapy with no adverse impact on cancer outcomes observed.

Original language	English
Article number	2301019
Pages (from-to)	1799-1809
Number of pages	11
Journal	Journal of Clinical Oncology
Volume	42
Issue number	15
Early online date	19 Apr 2024
DOIs	https://doi.org/10.1200/JCO.23.01019
Publication status	Published - 20 May 2024

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10.1200/JCO.23.01019

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11107897Licence: Other

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Fichtinger, R. S., Aldrighetti, L. A., Abu Hilal, M., Troisi, R. I., Sutcliffe, R. P., Besselink, M. G., Aroori, S., Menon, K. V., Edwin, B., D'Hondt, M., Lucidi, V., Ulmer, T. F., Díaz-Nieto, R., Soonawalla, Z., White, S., Sergeant, G., Olij, B., Ratti, F., Kuemmerli, C., ... ORANGE II PLUS Collaborative (2024). Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial. Journal of Clinical Oncology, 42(15), 1799-1809. Article 2301019. https://doi.org/10.1200/JCO.23.01019

@article{a5163c3345724ba1b12b5aa4a2e3df14,

title = "Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial",

abstract = "PURPOSE: To compare outcomes after laparoscopic versus open major liver resection (hemihepatectomy) mainly for primary or metastatic cancer. The primary outcome measure was time to functional recovery. Secondary outcomes included morbidity, quality of life (QoL), and for those with cancer, resection margin status and time to adjuvant systemic therapy. PATIENTS AND METHODS: This was a multicenter, randomized controlled, patient-blinded, superiority trial on adult patients undergoing hemihepatectomy. Patients were recruited from 16 hospitals in Europe between November 2013 and December 2018. RESULTS: Of the 352 randomly assigned patients, 332 patients (94.3\%) underwent surgery (laparoscopic, n = 166 and open, n = 166) and comprised the analysis population. The median time to functional recovery was 4 days (IQR, 3-5; range, 1-30) for laparoscopic hemihepatectomy versus 5 days (IQR, 4-6; range, 1-33) for open hemihepatectomy (difference, -17.5\% [96\% CI, -25.6 to -8.4]; < .001). There was no difference in major complications (laparoscopic 24/166 [14.5\%] open 28/166 [16.9\%]; odds ratio [OR], 0.84; = .58). Regarding QoL, both global health status (difference, 3.2 points; < .001) and body image (difference, 0.9 points; < .001) scored significantly higher in the laparoscopic group. For the 281 (84.6\%) patients with cancer, R0 resection margin status was similar (laparoscopic 106 [77.9\%] open 122 patients [84.1\%], OR, 0.60; = .14) with a shorter time to adjuvant systemic therapy in the laparoscopic group (46.5 days 62.8 days, hazard ratio, 2.20; = .009). CONCLUSION: Among patients undergoing hemihepatectomy, the laparoscopic approach resulted in a shorter time to functional recovery compared with open surgery. In addition, it was associated with a better QoL, and in patients with cancer, a shorter time to adjuvant systemic therapy with no adverse impact on cancer outcomes observed.",

author = "Fichtinger, \{Robert S\} and Aldrighetti, \{Luca A\} and \{Abu Hilal\}, Mohammed and Troisi, \{Roberto I\} and Sutcliffe, \{Robert P\} and Besselink, \{Marc G\} and Somaiah Aroori and Menon, \{Krishna V\} and Bj{\o}rn Edwin and Mathieu D'Hondt and Valerio Lucidi and Ulmer, \{Tom F\} and Rafael D{\'i}az-Nieto and Zahir Soonawalla and Steve White and Gregory Sergeant and Bram Olij and Francesca Ratti and Christoph Kuemmerli and Vincenzo Scuderi and Frederik Berrevoet and Aude Vanlander and Ravi Marudanayagam and Pieter Tanis and Dewulf, \{Maxime J L\} and Dejong, \{Cornelis H C\} and Zina Eminton and Kimman, \{Merel L\} and Lloyd Brandts and Neumann, \{Ulf P\} and Fretland, \{{\AA}smund A\} and Pugh, \{Si{\^a}n A\} and \{van Breukelen\}, \{Gerard J P\} and Primrose, \{John N\} and \{van Dam\}, \{Ronald M\} and \{ORANGE II PLUS Collaborative\}",

year = "2024",

month = may,

day = "20",

doi = "10.1200/JCO.23.01019",

language = "English",

volume = "42",

pages = "1799--1809",

journal = "Journal of Clinical Oncology",

issn = "0732-183X",

publisher = "Lippincott Williams \& Wilkins",

number = "15",

}

Fichtinger, RS, Aldrighetti, LA, Abu Hilal, M, Troisi, RI, Sutcliffe, RP, Besselink, MG, Aroori, S, Menon, KV, Edwin, B, D'Hondt, M, Lucidi, V, Ulmer, TF, Díaz-Nieto, R, Soonawalla, Z, White, S, Sergeant, G, Olij, B, Ratti, F, Kuemmerli, C, Scuderi, V, Berrevoet, F, Vanlander, A, Marudanayagam, R, Tanis, P, Dewulf, MJL, Dejong, CHC, Eminton, Z, Kimman, ML , Brandts, L , Neumann, UP, Fretland, ÅA, Pugh, SA, van Breukelen, GJP, Primrose, JN, van Dam, RM & ORANGE II PLUS Collaborative 2024, 'Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial', Journal of Clinical Oncology, vol. 42, no. 15, 2301019, pp. 1799-1809. https://doi.org/10.1200/JCO.23.01019

TY - JOUR

T1 - Laparoscopic Versus Open Hemihepatectomy

T2 - The ORANGE II PLUS Multicenter Randomized Controlled Trial

AU - Fichtinger, Robert S

AU - Aldrighetti, Luca A

AU - Abu Hilal, Mohammed

AU - Troisi, Roberto I

AU - Sutcliffe, Robert P

AU - Besselink, Marc G

AU - Aroori, Somaiah

AU - Menon, Krishna V

AU - Edwin, Bjørn

AU - D'Hondt, Mathieu

AU - Lucidi, Valerio

AU - Ulmer, Tom F

AU - Díaz-Nieto, Rafael

AU - Soonawalla, Zahir

AU - White, Steve

AU - Sergeant, Gregory

AU - Olij, Bram

AU - Ratti, Francesca

AU - Kuemmerli, Christoph

AU - Scuderi, Vincenzo

AU - Berrevoet, Frederik

AU - Vanlander, Aude

AU - Marudanayagam, Ravi

AU - Tanis, Pieter

AU - Dewulf, Maxime J L

AU - Dejong, Cornelis H C

AU - Eminton, Zina

AU - Kimman, Merel L

AU - Brandts, Lloyd

AU - Neumann, Ulf P

AU - Fretland, Åsmund A

AU - Pugh, Siân A

AU - van Breukelen, Gerard J P

AU - Primrose, John N

AU - van Dam, Ronald M

AU - ORANGE II PLUS Collaborative

PY - 2024/5/20

Y1 - 2024/5/20

N2 - PURPOSE: To compare outcomes after laparoscopic versus open major liver resection (hemihepatectomy) mainly for primary or metastatic cancer. The primary outcome measure was time to functional recovery. Secondary outcomes included morbidity, quality of life (QoL), and for those with cancer, resection margin status and time to adjuvant systemic therapy. PATIENTS AND METHODS: This was a multicenter, randomized controlled, patient-blinded, superiority trial on adult patients undergoing hemihepatectomy. Patients were recruited from 16 hospitals in Europe between November 2013 and December 2018. RESULTS: Of the 352 randomly assigned patients, 332 patients (94.3%) underwent surgery (laparoscopic, n = 166 and open, n = 166) and comprised the analysis population. The median time to functional recovery was 4 days (IQR, 3-5; range, 1-30) for laparoscopic hemihepatectomy versus 5 days (IQR, 4-6; range, 1-33) for open hemihepatectomy (difference, -17.5% [96% CI, -25.6 to -8.4]; < .001). There was no difference in major complications (laparoscopic 24/166 [14.5%] open 28/166 [16.9%]; odds ratio [OR], 0.84; = .58). Regarding QoL, both global health status (difference, 3.2 points; < .001) and body image (difference, 0.9 points; < .001) scored significantly higher in the laparoscopic group. For the 281 (84.6%) patients with cancer, R0 resection margin status was similar (laparoscopic 106 [77.9%] open 122 patients [84.1%], OR, 0.60; = .14) with a shorter time to adjuvant systemic therapy in the laparoscopic group (46.5 days 62.8 days, hazard ratio, 2.20; = .009). CONCLUSION: Among patients undergoing hemihepatectomy, the laparoscopic approach resulted in a shorter time to functional recovery compared with open surgery. In addition, it was associated with a better QoL, and in patients with cancer, a shorter time to adjuvant systemic therapy with no adverse impact on cancer outcomes observed.

AB - PURPOSE: To compare outcomes after laparoscopic versus open major liver resection (hemihepatectomy) mainly for primary or metastatic cancer. The primary outcome measure was time to functional recovery. Secondary outcomes included morbidity, quality of life (QoL), and for those with cancer, resection margin status and time to adjuvant systemic therapy. PATIENTS AND METHODS: This was a multicenter, randomized controlled, patient-blinded, superiority trial on adult patients undergoing hemihepatectomy. Patients were recruited from 16 hospitals in Europe between November 2013 and December 2018. RESULTS: Of the 352 randomly assigned patients, 332 patients (94.3%) underwent surgery (laparoscopic, n = 166 and open, n = 166) and comprised the analysis population. The median time to functional recovery was 4 days (IQR, 3-5; range, 1-30) for laparoscopic hemihepatectomy versus 5 days (IQR, 4-6; range, 1-33) for open hemihepatectomy (difference, -17.5% [96% CI, -25.6 to -8.4]; < .001). There was no difference in major complications (laparoscopic 24/166 [14.5%] open 28/166 [16.9%]; odds ratio [OR], 0.84; = .58). Regarding QoL, both global health status (difference, 3.2 points; < .001) and body image (difference, 0.9 points; < .001) scored significantly higher in the laparoscopic group. For the 281 (84.6%) patients with cancer, R0 resection margin status was similar (laparoscopic 106 [77.9%] open 122 patients [84.1%], OR, 0.60; = .14) with a shorter time to adjuvant systemic therapy in the laparoscopic group (46.5 days 62.8 days, hazard ratio, 2.20; = .009). CONCLUSION: Among patients undergoing hemihepatectomy, the laparoscopic approach resulted in a shorter time to functional recovery compared with open surgery. In addition, it was associated with a better QoL, and in patients with cancer, a shorter time to adjuvant systemic therapy with no adverse impact on cancer outcomes observed.

U2 - 10.1200/JCO.23.01019

DO - 10.1200/JCO.23.01019

M3 - Article

SN - 0732-183X

VL - 42

SP - 1799

EP - 1809

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

IS - 15

M1 - 2301019

ER -

Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial

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