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

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 s...

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Vydáno v:Journal of clinical oncology Ročník 42; číslo 15; s. 1799
Hlavní autoři: Fichtinger, Robert S, Aldrighetti, Luca A, Abu Hilal, Mohammed, Troisi, Roberto I, Sutcliffe, Robert P, Besselink, Marc G, Aroori, Somaiah, Menon, Krishna V, Edwin, Bjørn, D'Hondt, Mathieu, Lucidi, Valerio, Ulmer, Tom F, Díaz-Nieto, Rafael, Soonawalla, Zahir, White, Steve, Sergeant, Gregory, Olij, Bram, Ratti, Francesca, Kuemmerli, Christoph, Scuderi, Vincenzo, Berrevoet, Frederik, Vanlander, Aude, Marudanayagam, Ravi, Tanis, Pieter, Dewulf, Maxime J L, Dejong, Cornelis H C, Eminton, Zina, Kimman, Merel L, Brandts, Lloyd, Neumann, Ulf P, Fretland, Åsmund A, Pugh, Siân A, van Breukelen, Gerard J P, Primrose, John N, van Dam, Ronald M
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 20.05.2024
Témata:
Adult
Aged
Female
Hepatectomy - adverse effects
Hepatectomy - methods
Humans
Laparoscopy - adverse effects
Laparoscopy - methods
Liver Neoplasms - secondary
Liver Neoplasms - surgery
Male
Middle Aged
Postoperative Complications - epidemiology
Postoperative Complications - etiology
Quality of Life
Treatment Outcome
ISSN:1527-7755, 1527-7755
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Abstract 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. 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. 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). 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.
AbstractList 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.PURPOSETo 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.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.PATIENTS AND METHODSThis 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.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]; P < .001). There was no difference in major complications (laparoscopic 24/166 [14.5%] v open 28/166 [16.9%]; odds ratio [OR], 0.84; P = .58). Regarding QoL, both global health status (difference, 3.2 points; P < .001) and body image (difference, 0.9 points; P < .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%] v open 122 patients [84.1%], OR, 0.60; P = .14) with a shorter time to adjuvant systemic therapy in the laparoscopic group (46.5 days v 62.8 days, hazard ratio, 2.20; P = .009).RESULTSOf 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]; P < .001). There was no difference in major complications (laparoscopic 24/166 [14.5%] v open 28/166 [16.9%]; odds ratio [OR], 0.84; P = .58). Regarding QoL, both global health status (difference, 3.2 points; P < .001) and body image (difference, 0.9 points; P < .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%] v open 122 patients [84.1%], OR, 0.60; P = .14) with a shorter time to adjuvant systemic therapy in the laparoscopic group (46.5 days v 62.8 days, hazard ratio, 2.20; P = .009).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.CONCLUSIONAmong 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.
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. 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. 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). 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 van Breukelen, Gerard J P
Ulmer, Tom F
Brandts, Lloyd
Marudanayagam, Ravi
Aroori, Somaiah
Edwin, Bjørn
Abu Hilal, Mohammed
Scuderi, Vincenzo
Sutcliffe, Robert P
Fichtinger, Robert S
Eminton, Zina
D'Hondt, Mathieu
Neumann, Ulf P
Menon, Krishna V
Olij, Bram
Dewulf, Maxime J L
Berrevoet, Frederik
White, Steve
Díaz-Nieto, Rafael
Sergeant, Gregory
Vanlander, Aude
Lucidi, Valerio
Besselink, Marc G
Ratti, Francesca
Kuemmerli, Christoph
Pugh, Siân A
Fretland, Åsmund A
Tanis, Pieter
Dejong, Cornelis H C
van Dam, Ronald M
Kimman, Merel L
Soonawalla, Zahir
Aldrighetti, Luca A
Troisi, Roberto I
Primrose, John N
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/38640453$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Contributor Aldrighetti, Luca
Robinson, Stuart
van Laethem, Viviane
Marudanayagam, Ravi
Aroori, Somaiah
Dewulf, Maxime
Scuderi, Vincenzo
Abu Hilal, Mohammed
Aghayan, Davit
Eminton, Zina
Berrevoet, Frederik
van Breukelen, Gerard
White, Steve
Sergeant, Gregory
Lintforth, Michelle
Ratti, Francesca
Fretland, Åsmund
Zamalloa, Ane
van Dam, Ronald
Soonawalla, Zahir
Gordon-Quayle, Katherine
Brandts, Lloyd
Demeyere, Celine
Edwin, Björn
Primrose, John
Rogers, Penelope
Gorçek, Burak
Clausen, Finja
Kümmerli, Christopher
Ward, Tracy
Boxal, Jess
D'Hondt, Mathieu
Olij, Bram
Ulmer, Florian
Brunton, Caroline
Díaz-Nieto, Rafael
van der Poel, Marcel
Vanlander, Aude
Dejong, Cornelis
Lucidi, Valerio
Sutcliffe, Robert
Kimman, Merel
Besselink, Marc
Fichtinger, Robert
Segers, Kathleen
Tanis, Pieter
van Loo, Betsy
Neumann, Ulf
Menon, Krishna
Troisi, Roberto
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PublicationTitle Journal of clinical oncology
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Snippet To compare outcomes after laparoscopic versus open major liver resection (hemihepatectomy) mainly for primary or metastatic cancer. The primary outcome measure...
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SubjectTerms Adult
Aged
Female
Hepatectomy - adverse effects
Hepatectomy - methods
Humans
Laparoscopy - adverse effects
Laparoscopy - methods
Liver Neoplasms - secondary
Liver Neoplasms - surgery
Male
Middle Aged
Postoperative Complications - epidemiology
Postoperative Complications - etiology
Quality of Life
Treatment Outcome
Title Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial
URI https://www.ncbi.nlm.nih.gov/pubmed/38640453
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