(MIS) - Medtronic...(mis) global value dossier for minimally invasive surgery (mis) liver resection

(MIS)

GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY (MIS)

LIVER RESECTION

Global Value Dossier: Liver Resection 2

Prepared by: Jayne Smith-Palmer and Richard Pollock

Ossian Health Economics and Communications, Bäumleingasse 20, 4051 Basel, Switzerland

Phone: +41 61 271 6214

E-mail: [email protected]

Version No. 2.1

Date: March 29, 2016


Contents

1. Liver resection .................................................................................................................... 4

1.1. Overview of procedure .............................................................................................. 4

1.2. Clinical and economic outcomes with laparoscopic versus open liver resection .... 7

1.1.1. Clinical and economic evidence tables ............................................................ 13

1.3. References ............................................................................................................... 24

List of Tables

Table 1-1 Summary of meta-analyses comparing laparoscopic versus open liver resection .............................................................................................................................. 14

Table 1-2 Summary of key clinical studies comparing laparoscopic versus open liver resection............................................................................................................... 15

Table 1-3 Summary of key studies comparing economic outcomes of laparoscopic versus open liver resection .............................................................................................. 22

List of Figures

Figure 1-1 Port placement for 4 laparoscopic liver resection operations: 1) S6 partial hepatectomy, 2) lateral segmentectomy, 3) S4 partial hepatectomy, and 4) S5 partial hepatectomy ........................................................................................... 4

Figure 1-2 Port and cart placement for robotic right hepatectomy. A Port placement: 1) optical port, 2) 8mm trocar for right operating arm, 3) 8mm trocar for left operating arm, and 4) 8mm trocar for fourth robotic arm. A indicates assistant port. B Robotic cart placement .......................................................................... 5

Figure 1-3 Temporal trends in laparoscopic liver resection for benign liver tumors stratified by patients and hospital ..................................................................... 5

Figure 1-4 Length of stay for laparoscopic versus open liver resection ............................ 9

Figure 1-5 Operating time for laparoscopic versus open liver resection ......................... 10

Figure 1-6 Blood loss for laparoscopic versus open liver resection ................................. 11

Figure 1-7 Rates of surgical site infection for laparoscopic versus open liver resection . 12

Figure 1-8 Total hospital costs for laparoscopic versus open liver resection in US-based studies .............................................................................................................. 13


1. Liver resection

1.1. Overview of procedure

Liver resection or hepatectomy is the surgical removal of all or part of the liver, referred to as full or partial hepatectomy, respectively. The procedure is widely performed for the treatment of various liver diseases, such as malignant tumors, benign tumors, calculi in the intrahepatic ducts, hydatid disease, and abscesses.1 The most common indication for laparoscopic liver resection is a solitary liver metastasis from a colorectal cancer, but it may also be used for hepatocellular carcinoma (HCC) and for benign liver tumours or cysts.2 Despite technical advances, liver resection is still burdened by relatively high rates of post-operative morbidity (4.09%−47.7%) and mortality (0.24%−9.7%).1 Common post-hepatectomy complications include fever, hemorrhage, bile leakage, liver failure, pleural effusion, and subphrenic infection.1

Laparoscopic hepatectomy can be achieved with a variety of different port placements, facilitating multiple resections with minimal adhesions in patients with recurrent disease (Figure 1-1).3 Typical port and cart placement for robotic hepatectomy is illustrated in Figure 1-2.4

Figure 1-1 Port placement for 4 laparoscopic liver resection operations: 1) S6 partial hepatectomy, 2) lateral segmentectomy, 3) S4 partial hepatectomy, and 4) S5 partial hepatectomy


Figure 1-2 Port and cart placement for robotic right hepatectomy. A Port placement: 1) optical port, 2) 8mm trocar for right operating arm, 3) 8mm trocar for left operating arm, and 4) 8mm trocar for fourth robotic arm. A indicates assistant port. B Robotic cart placement

The proportion of liver resections conducted laparoscopically has been increasing steadily from 2000-2011, with 6.2% of all benign tumor resection procedures conducted laparoscopically in patients aged under 65 years in the United States between 2008-2011 according to data from the Nationwide Inpatient Sample database (Figure 1-3).5

Figure 1-3 Temporal trends in laparoscopic liver resection for benign liver tumors stratified by patients and hospital

3.94.6

6.2

3.6

5.1

6.4

6.8

2000-2003 2004-2007 2008-2011

Pe

rce

nta

ge

of

of

liv

er

rese

ctio

ns

carr

ied

ou

t la

pa

rosc

op

ical

ly (%

)

Year

Age <65 Female

Teaching hospital Urban hospital


Guidelines on laparoscopic liver resection

2005 United Kingdom National Institute for Health and Care Excellence interventional procedure guidance on laparoscopic liver resection

Evidence on the safety and efficacy of laparoscopic liver resection is adequate to support the use of the procedure

o In five studies (n=217) that compared laparoscopic liver resection with open resection in patients with malignant tumors, there were no statistically significant differences in the extent of the resection margins

o Four of six non-randomized comparative studies reported that the post-operative hospital stay was significantly shorter after laparoscopic liver resection (mean stay ranged from 4 to 15 days) than after open liver resection (mean stay ranged from 8 to 22 days)

Patient selection for laparoscopic liver resection should be carried out by a multidisciplinary team. Surgeons undertaking laparoscopic liver resection should have specialist training and expertise both in laparoscopic techniques and in the specific issues relating to liver surgery

2015 Recommendations for laparoscopic liver resection: a report from the second international consensus conference held in Morioka, Japan6

Minor laparoscopic liver resection is confirmed to be a standard practice in surgery but is still in an assessment phase (IDEAL 3) as it is adopted by an increasing proportion of surgeons. Judged as a whole, available literature studies indicated that some outcomes such as certain post-operative complications and length of stay were superior to open procedures and no outcomes were inferior. Unfortunately, the quality of studies is generally designated as low. Thus, additional higher quality studies are suggested to define its role and benefits in relation to open surgery

Major laparoscopic liver resection is an innovative procedure. It is still in an exploration or learning phase (IDEAL 2b) and has incompletely defined risks. It should continue to be introduced cautiously. Judged as a whole, available literature studies indicated that length of stay is superior to open procedures and other outcomes were not inferior. Blood loss is also reported to be less but questions remain regarding the methodology used. Again, the quality of studies is generally designated as low. Therefore, there are strong recommendations for additional higher quality studies including registries to define its role and benefits in relation to open surgery


1.2. Clinical and economic outcomes with laparoscopic versus open liver resection

Key findings

Clinical outcomes

Length of stay: Length of stay was shorter with laparoscopic liver resection than open resection in all studies assessed11,12,13,14,15,16,17,19,20,21,22,23,24,25,26,27 and significantly lower in the majority of studies11,13,14,15,16,17,19,20,21,22,23,26,27 only three studies showed a non-significant difference12,24,25

Operating time: Differences in operating time varied across the included studies, with a majority of studies reporting a non-significant difference in operative time12,13,14,15,19,21,23,24,26,27

Mortality: The Parks et al. meta-analysis reported lower rates of mortality with laparoscopic liver resection relative to open liver resection9

Complications: Where studies assessed operative and post-operative complications, data consistently favored laparoscopic liver resection over open resection11,22,25,26

Blood loss: Of the studies that reported blood loss, the majority of studies also reported a significant reduction with laparoscopic surgery11,12,16,18,19,21,22,23

Blood transfusion: Three studies reported a significantly lower proportion of patients requiring blood transfusion with laparoscopic versus open liver resection,11,19,25 however, several others reported no significant difference14,15,17,21,26

Economic outcomes

Total hospital costs: Overall, laparoscopic liver resection was associated with higher operative costs15,17,19 but with lower post-operative costs relative to open liver resection19,28

o United States: In two US-based studies laparoscopic liver resection was associated with lower overall costs than open liver resection; however, this did not achieve statistical significance,16,29 in a third US study laparoscopic liver resection was also associated with lower costs for on-course procedures, but not for procedures with deviations from procedure11

o Japan: In Japan, total hospital costs were higher, but not significantly so with laparoscopic liver resection than with open liver resection13

Savings due to clinical benefits: A systematic review of cost studies showed that lower overall costs with laparoscopic liver resection were driven by lower ward stay costs and lower high dependency unit costs, which in turn are likely attributable to a shorter length of stay and lower complication rate with laparoscopic liver resection

Other findings

Learning curve: A learning curve is evident with laparoscopic liver resection with operating time and blood loss decreasing as surgeon experience increased7

Time to mobilization: Time to first mobilization was significantly shorter for laparoscopic liver resection than for open liver resection20


Conversion: For laparoscopic liver resection significant risk factors for conversion to open surgery include resection of the postero-superior segments and major (compared with minor) resection8


Figure 1-4 Length of stay for laparoscopic versus open liver resection

6.4

27

12

13.4

7 7

14.3

8

10

14.5

12

8

14.4

17.1

13.5

20

4.2

18.3

8 7.7

45

7.9

5 5

9.410

5

7.6

12

8.2

13

Ca

nn

on

20

13

Iwa

ha

shi

20

13

Ka

wa

gu

chi

20

15 K

im2

01

3

Lo

pe

z-B

en

20

14

Me

db

ery

20

14

Sh

in2

01

5

Sli

m2

01

2

Wa

ng

20

15

Xia

o2

01

5

Lu

o2

01

5

Zh

an

g2

01

5

Sin

isca

lch

i2

01

4 Kim

20

15

Ai

20

13

Hu

20

11

Le

ng

th o

f st

ay

, da

ys

Open Laparoscopic

**

ns

** **

******

***

*** ***

****

*

ns

ns

*

**

*p<0.05; **p<0.01; ***p<0.001; ns, not significant


Figure 1-5 Operating time for laparoscopic versus open liver resection

369

258

203

475

285

210

170

235

150 150165

282

255

170

377369

210

401

233

174

155

242

180

120

175

216

245

180

Iwa

ha

shi

20

13

Ka

wa

gu

chi

20

15 K

im2

01

3

Lo

pe

z-B

en

20

14

Me

db

ery

20

14

Sh

in2

01

5

Slim

20

12

Xia

o2

01

5

Lu

o2

01

5

Zh

an

g2

01

5

Sin

isca

lch

i2

01

4 Kim

20

14

AI

20

13

Hu

20

11

Op

era

tin

g t

me

, min

ute

s

Open Laparoscopic

nsns

ns

ns

***

**ns

ns

*

ns

ns

**

ns

ns



Figure 1-6 Blood loss for laparoscopic versus open liver resection

484

326

541

261

475

737

378

988

200

450

290

328

454480

194 198

150

484

401

281263

95 100

272

210 200

460

520

Ca

nn

on

20

13

Iwa

ha

shi

20

13

Ka

wa

gu

chi

20

15 K

im2

01

3

Lo

pe

z-B

en

20

14

Me

db

ery

20

14

Sh

in2

01

5

Sla

ke

y2

01

3

Sli

m2

01

2

Xia

o2

01

5

Lu

o2

01

5

Zh

an

g2

01

5

Ai

20

13

Hu

20

11

Blo

od

loss

, mL

Open Laparoscopic

*** *

ns

ns

ns

** ns

*** *

***

* *

ns

ns



Figure 1-7 Rates of surgical site infection for laparoscopic versus open liver resection

6.9 7

3.3

0

2.8

3.3

6.9

0

3.3

5.3

1

0

Kim2013

Lopez-Ben2014

Wang2015

Kim2014

Ai2013

Hu2011

Su

rgic

al s

ite

infe

ctio

n, %

Open Laparoscopic

ns

ns

nr

nr

*

nr

*p<0.05; **p<0.01; ***p<0.001; nr, not reported; ns, not significant


Figure 1-8 Total hospital costs for laparoscopic versus open liver resection in US-based studies

26,751

18,043

25,679

15,104

Medbery2014

Vanounou2010

To

tal h

osp

ita

l co

st, U

SD

Open Laparoscopic

ns

nr

nr, not reported; ns, not significant

1.1.1. Clinical and economic evidence tables

A summary of clinical evidence on laparoscopic versus open pancreatectomy from published meta-analyses and published studies is shown in Table 1-1 and Table 1-2, respectively. A summary of economic evidence from published cost studies is shown in Table 1-3.

In the following tables outcomes where p<0.05 are underlined.


Table 1-1 Summary of meta-analyses comparing laparoscopic versus open liver resection

Authors Details Procedures Outcome Outcome P value

Parks et al. 20139 Random effects meta-analysis of 15 studies (N=1,002, 556 open hepatectomy, 446 laparoscopic hepatectomy)

Laparoscopic versus open liver resection for solid tumors (in studies reporting 1-, 3- or 5-year overall survival for patients with malignancies)

Peri-operative Operative time, hours Blood loss, mL Oncological margins Post-operative Length of hospital stay Post-operative mortality Survival All-cancers, risk of death, 1-year All-cancers, risk of death, 3-year All-cancers, risk of death, 5-year HCC, risk of death, 1-year HCC, risk of death, 3-year HCC, risk of death, 5-year CRM, risk of death, 1-year CRM, risk of death, 3-year

−5.82 (−7.59, 19.23)a −104 (0.7, 207)a

Analysis not possible 15 studies favoring laparoscopy 0.7% laparoscopy; 1.5% open 0.71 (0.42, 1.20)b 0.76 (0.56, 1.03)b 0.80 (0.59, 1.10)b 0.78 (0.43, 1.42)b 0.95 (0.64, 1.39)b 0.81 (0.57, -1.15 b 0.55 (0.17, 1.80)b 0.49 (0.25, 0.95)b

0.395 0.048 N/A Significant NR 0.202 0.076 0.173 0.422 0.778 0.239 0.325 0.036

Rao et al. 201210 Random effects meta-analysis of 10 studies (N=700)

Laparoscopic (296/700) versus open (404/700) hepatic resections for malignant lesions

Peri-operative Operative time Operative blood loss, mL Transfusions Use of portal triad clamping Post-operative Time to first oral intake, days Length of hospital stay, days Overall complication rate

NR −163 (-262, 73)a

0.35 (0.20, 0.60)b

0.08 (0.01, 0.46)b −1.3 (−2.2, −0.4)a

−4.3 (−6.3, −2.2)a

0.4 (0.3, 0.7)b

0.71 <0.001 <0.001 0.005 0.007 <0.001 0.002

CRM, colorectal metastases; HCC, hepatocellular carcinoma; NR, not reported. a Weighted mean difference, negative values indicate a reduced value with laparoscopic liver resection b Odds ratios are reported as OR (95% confidence interval). Values less than 1 favor laparoscopic liver resection


Table 1-2 Summary of key clinical studies comparing laparoscopic versus open liver resection Study Setting Study details Procedure (year

performed) Summary of clinical findings Endpoint Open Laparoscopic P value

Cannon et al. 201311

United States

Retrospective review of 98 consecutive patients at a single institution from 2007 through 2011 undergoing first-time hepatic resection

Open versus laparoscopic hepatic resection (2007−2011)

Overall population (N=98) Peri-operative On course operations, % Mean (SD) blood loss, mL Transfusion required, % Patients experiencing complications, % Post-operative Mean (SD) LoS, days Right hepatectomy subgroup (n=45) Peri-operative On course operations,% Mean (SD) blood loss, mL Transfusion required, % Patients experiencing complications, % Post-operative Mean (SD) LoS, days

27 484 (427) 29 42 6.4 (2.6) 32 527 (503) 36.4 27.3 5.9 (2.0)

74 194 (183) 7.0 23 4.2 (5.3) 65 248 (220) 8.7 34.8 4.0 (1.8)

<0.001 <0.001 0.003 0.048 0.009 NR 0.024 0.035 0.587 0.002

Iwahashi et al. 201312

Japan Database analysis of 21 laparoscopic resection colorectal liver metastasis patients matched with 21 consecutive open resection patients matched by tumor size

Open versus laparoscopic liver resection (2007−2012)

Peri-operative Mean (SD) operative time, minutes Mean (SD) blood loss, mL Post-operative Patients experiencing complications, n Mean LoS, days 1 year overall survival, % 3 year overall survival, % 5 year overall survival, % 1 year disease-free survival, % 3 year disease-free survival, % 5 year disease-free survival, %

369 (31) 326 (50) 5 27.0 89 89 51 64 33 25

377 (29) 198 (39) 2 18.3 100 84 42 57 14 14

ns <0.05 0.21 0.14 ns ns ns ns ns ns

Kawaguchi et al. 201513

Japan Retrospective analysis of 65 patients undergoing laparoscopic (n=17) or open (n=48)


Peri-operative Median (range) operative time, minutes Median (range) blood loss, mL Inflow occlusion, % Median (range) time of occlusion, minutes

258 (123, 490) 541 (0, 1716) 60 120 (50, 194)

369 (165, 602) 150 (0, 675) 88 57 (17, 151)

0.11 0.07 0.16 0.03




hepatectomy performed by a single surgeon

Post-operative Median (range) postoperative LoS, days Median (range) total LoS, days Median (range) AST POD 1, U/L Median (range) AST POD 3, U/L Median (range) bilirubin POD 1, mg/dL Median (range) bilirubin POD 3, mg/dL Median (range) INR POD 1 Median (range) INR POD 3 Median (range) tube drainage POD 1, mL Median (range) tube drainage POD 3, mL

9 (5, 12) 12 (9, 15) 186 (68, 386) 65 (29, 169) 1 (0.5, 1.49) 0.8 (0.4, 1.2) 1.19 (1.04, 1.49) 1.16 (1.01, 1.29) 150 (2, 400) 85 (0, 300)

5 (4, 6) 8 (7, 13) 310 (147, 1424) 115 (50, 413) 0.9 (0.5, 1.6) 0.9 (0.5, 1.5) 1.14 (1.01, 1.46) 1.13 (1.00, 1.80) 30 (10, 90) 10 (0, 190)

<0.01 <0.01 0.01 0.18 0.79 0.10 0.62 0.67 <0.01 0.04

Kim et al. 201314

Korea Retrospective, propensity-score matched analysis of 58 patients undergoing laparoscopic (n=29) versus open (n=29) liver resection at Seoul National University Hospital


Peri-operative Mean (SD) operative time, minutes Mean (SD) clamping time, minutes Mean (SD) estimated blood loss, mL Transfusions, % Post-operative ICU stay, % Mean (SD) ICU LoS, days Mean (SD) hospital stay, days Overall complication rate, % Wound infection, % Bile leakage, % Postoperative ascites, % Oncologic and long-term outcomes Overall recurrence rate, % Time to recurrence, months (range) Overall mortality, % Mean (SD) overall survival, months Mean (SD) disease-free survival, months 5-year survival, %

203 (51) 4.7 (9.2) 261 (301) 0.0 17.2 0.4 (1.0) 13.4 (7.4) 38 6.9 6.9 0.0 55 32.57 (26.29) 20.7 59.5 (35.4) 39.8 (32.7) 88

210 (82) 5.9 (14.6) 484 (820) 3.4 17.2 0.5 (1.1) 7.7 (2.9) 13.8 6.9 6.9 17.2 38 15.43 (5.44) 6.9 47.9 (29.9) 33.4 (29.1) 92

0.681 0.790 0.065 0.317 1.000 0.952 0.001 0.118 1.000 1.000 0.025 0.839 0.120 0.219 0.168 0.361 NR

López-Ben et al. 201415

Spain Retrospective 2:1 control case-matched study of

Open versus laparoscopic liver

Peri-operative Median blood loss, mL (range) Median operative time, minutes (range)

475 (20, 2,000) 200 (70, 450)

401 (18, 2,192) 295 (120, 600)

0.89 0.0001




consecutive laparoscopic (n=50) hepatectomies versus open (n=100) hepatectomies

resection (2005−2012)

Conversions, % Post-operative Overall morbidity, % Biliary fistula, % Hemoperitoneum, % Surgical site infection, % Intraabdominal abscess, % Ascites, % Transfusions, % Reoperation, % Mortality, % Median (range) hospital stay, days Readmissions, %

N/A 36 3 4 18 12 4 20 3 1 7 (3, 44) 7

12 36 0 8 2 2 8 16 2 2 4 (1, 60) 0

N/A 1.00 0.29 0.25 0.007 0.033 0.44 0.94 0.59 0.65 0.0001 0.09

Medbery et al. 201416

United States

Retrospective record review of elective laparoscopic (n=48) and open (n=57) hepatectomy for both benign and malignant conditions at Emory University Hospital


Peri-operative Mean (SD) case time, minutes Mean (SD) operative room time, minutes Mean (SD) estimated blood loss, mL Portal triad clamping, % Crystalloid IV fluid requirement, mL (SD) Red blood cell units transfused, units Arterial line monitoring, % Central venous line monitoring, % Post-operative ICU admissions, % Mean (SD) ICU days, days Post-operative complications, % Median (range) hospital LoS, days 30-day emergency room visit, % 30-day readmissions, % 30-day mortality, %

222 (81) 285 (85) 737 (947) 49.1 2,607 (1,161) 0.60 70 40.4 54 2.6 (3.1) 44 7 (4, 35) 12.3 7.0 3.5

174 (29) 233 (32) 281 (306) 8.3 1,906 (796) 0.13 21 6.3 17 2.0 (2.2) 27 5 (3, 31) 16.7 14.6 4.2

<0.001 <0.001 0.002 <0.001 0.01 0.14 <0.001 <0.001 <0.001 0.64 0.075 <0.001 0.52 0.34 1.00

Shin et al. 201517

Korea Retrospective review of 195 patients with IHD stones undergoing

Open versus laparoscopic liver resection, including hemihepatectomy

Peri-operative Mean (SD) operation time, minutes Mean (SD) estimated blood loss, mL Intraoperative transfusion, %

210 (52) 378(433) 7.4

174(57) 263 (166) 7.5

0.002 0.150 0.987




left-sided laparoscopic hepatectomy (n=40) or open hepatectomy (n=155)

and left lateral sectionectomy (2002−2013)

Post-operative Mean (SD) hospital stay, days Complications, % Wound problems, % Intraabdominal fluid collection, % Biliary fistula, % T-tube tractitis, % Initial residual stone, % Final residual stone, % Recurrent stone, %

14.3 (5.5) 40.7 18.5 14.8 3.7 3.7 24.1 5.6 5.6

7.9 (2.6) 17.5 5 12.5 0 0 12.5 0 2.5

<0.001 0.015 0.052 0.748 0.219 0.219 0.159 0.130 0.468

Slakey et al. 201318

United States

Retrospective chart review (N=62) in patients undergoing laparoscopic (n=45) versus open (n=17) resection of hepatic lesions

Open versus laparoscopic liver resection (year not reported)

Peri-operative Mean (range) blood loss, mL Post-operative Cases with complications, % Mortality at 30 days, % Mortality at 12 months, % IV pain medications >5 days, % ICU stay >5 days, % Hospital stay >10 days, % Postoperative ileus >4 days, %

988 (10, 5,000) 53 6 18 29 29 35 18

95 (0, 350) 16 0 0 11 7 7 2

0.0001 0.007 0.86 0.06 0.17 0.05 0.01 0.10

Slim et al. 201219

Italy Retrospective 1:1 control case-matched study of laparoscopic (n=46) versus open (n=46) hepatectomy at the Niguarda Ca’ Granda Hospital, Milan

Open (2006−2008) versus laparoscopic (2008−2011) liver resection

Peri-operative Mean (range) blood loss, mL Transfusions, % Operative time (range), minutes Post-operative Hospital stay, days (range) Mild liver failure, % Moderate–severe liver failure, % Biliary leakage, % Abdominal collection/abscesses, % Septic shock, % Pneumonia, % Pleural effusion, % Intra-abdominal bleeding, %

200 (50, 2,000) 17.4 170 (85, 315) 8 (5, 54) 6.5 6.5 6.5 6.5 6.5 4.3 10.9 4.3

100 (10, 800) 4.3 155 (45, 400) 5 (3, 22) 4.6 − − 2.2 − − 7.0 −

0.048 0.040 0.098 <0.001 NR NR NR NR NR NR NR NR




Abdominal chronic pain, % Subclavian vein thrombosis, %

2.2 2.2

− −

NR NR

Wang et al. 201520

China Retrospective matched analysis of 30 elderly (≥70 years) patients undergoing laparoscopic resection for malignant carcinoma versus 1:2 open resection controls at the Chinese PLA General Hospital


Post-operative Patients with ICU stay, % ICU LoS, days (range) First pure liquid diet, days (range) First mobilization out of bed, days (range) Hospital LoS, days (range) Post-operative complications, % Pleural effusion Wound infection Chest infection Bile leak Ascites

38.3 0 (0, 3.9) 1.6 (0.6,6.6) 2.8 (0.6, 9.9) 10 (7, 22) 16.7 3.3 3.3 1.67 1.67 3.3

11.5 0 (0, 1.1) 1.0 (0.4, 3.7) 1.7 (0.6, 3.8) 5 (3, 16) 10.0 3.3 3.3 0 3.3 0

0.006 0.004 0.017 <0.001 <0.001 0.532

Xiao et al. 201521

China Retrospective evaluation for hepatocellular carcinoma by laparoscopy (n=41) or open surgery (n=86) at Southwest Hospital, Third Military Medical University, China


Peri-operative Mean (SD) operative time, minutes Mean (SD) blood loss, mL Transfusions, % Post-operative Mean (SD) post-operative stay, days

235 (66) 450 (345) 14 14.5 (6.0)

242 (74) 272 (171) 7 9.4 (2.7)

0.589 0.001 0.430 0.000

Luo et al. 201522

China Retrospective matched case-control study, n=53 laparoscopic, n=53 open

Open versus laparoscopic hepatectomy for hepatocellular carcinoma (2008–2015)

Peri-operative Median (range) operating time, minutes Median (range) blood loss, mL Post-operative Median (range) LoS, days Overall complications, %

150 (120, 280) 290 (190, 450) 12 (8, 35) 36

180 (150, 380) 210 (190, 450) 10 (7, 25) 30

0.025 0.012 0.015 0.536

Zhang et al. 201523

China Single center retrospective cohort study, n=30

Open versus laparoscopic left segmentectomy (2009–2013)

Peri-operative Mean (SD) operating time, minutes Mean (SD) blood loss, mL Mean resection margins, mm

150 (37) 328 (37) 21.5

120 (30) 200 (22) 20

ns <0.05 ns




laparoscopic, n=20 open

Post-operative Mean (SD) LoS, days

8 (1)

5 (1)

<0.05

Siniscalchi et al. 201424

Italy Retrospective single center analysis, n=23 laparoscopic, n=133 open

Open versus laparoscopic minor hepatic resection for hepatocellular carcinoma (2005–2010)

Peri-operative Mean (SD) operating time, minutes Post-operative Mean (SD) LoS, days Ascites, % Jaundice, % Liver failure, %

165 (80) 14.4 (21.8) 26 23 6.8

175 (91) 7.6 (5.5) 13 44 0

0.588 0.339 0.288 0.067 0.357

Kim et al. 201425

Korea Retrospective single center analysis, n=70 laparoscopic, n=76 open (propensity matched)

Laparoscopic versus open liver resection for hepatocellular carcinoma (2004–2012)

Peri-operative Mean (SD) operating time, minutes Transfusion, % Post-operative Complication, % Wound infection, % Mean (SD) LoS, days Mean (SD) resection margin, cm

282 (80) 41 14.5 0 17.1 (15.9) 0.80 (0.82)

216 (122) 24 7.1 5.3 12.0 (23.0) 1.07 (1.37)

0.001 0.001 0.450 NR 0.440 0.147

Ai et al. 201326 China Retrospective single center analysis, n=97 laparoscopic, n=178 open

Open versus laparoscopic liver resection for hepatocellular carcinoma with tumor size 5–10 cm (2007–2011)

Peri-operative Mean (SD) operating time, minutes Mean (SD) blood loss, mL Blood transfusion, % Resection margin, cm Post-operative Mean (SD) LoS, days Complications, % Clavien I Clavien II Clavien III Wound infection, % Ascites, % Bile leakage, %

225 (112) 454 (365) 2.8 1.36 (0.62) 13.5 (3.8) 10.1 14.0 3.9 2.8 2.2 2.8

245 (105) 460 (426) 4.6 1.53 (0.59) 8.2 (3.6) 3.1 7.2 0 1.0 0 0

0.469 0.913 0.480 0.818 0.028 0.000 0.003 0.002 0.010 0.003 0.001

Hu et al. 201127 China Retrospective single center analysis,

Laparoscopic vs open liver lobectomy

Peri-operative Mean (SD) operating time, minutes Mean (SD) blood loss, mL

170 (32) 480 (46)

180 (45) 520 (30)

ns ns




n=30 laparoscopic, n=30 open

(segmentectomy) for hepatocellular carcinoma (2006–2011)

Post-operative Mean (SD) time to ambulation, days Mean (SD) time to oral intake, days Mean (SD) LoS, days Complications, % Wound infection, % Bile leakage, %

5.7 (3.2) 5.5 (1.6) 20 (3.2) 10 3.3 0

2.3 (2.5) 2.2 (1.4) 13 (2.1) 13.3 0 10

<0.01 <0.05 <0.01 ns NR NR

AST, aspartate aminotransferase; ICU, intensive care unit; INR, international normalized ratio; LoS, length of stay; N/A not applicable; NR, not reported; POD postoperative day; SD, standard deviation


Table 1-3 Summary of key studies comparing economic outcomes of laparoscopic versus open liver resection Study Setting Study details Procedures Currency

(Cost year) Cost Outcome Open Laparoscopic P value

Cannon et al. 201311

United States

Retrospective review of 98 consecutive patients at a single institution from 2007 through 2011 undergoing first-time hepatic resection

Open versus laparoscopic hepatic resection

USD (cost year not specified)

Median total hospital charges On course Minor deviation Moderate deviation Major deviation Median operative changes On course Minor deviation Moderate deviation Major deviation

54,704 60,665 80,734 138,606 31,400 32,949 36,845 45,429

49,994 63,878 93,979 NA 34,019 32,974 49,639 NA

0.402 0.544 0.208 NA 0.131 0.828 0.112 NA

Kawaguchi et al. 201513

Japan Retrospective analysis of laparoscopic (n=17) or open (n=48) hepatectomy performed by a single surgeon


JPY (2013) Mean (SD) operation charge Mean (SD) surgical costs Total (SD) treatment charge Mean (SD) charge per day Rough (SD) balance Rough (SD) balance per day

396,256 (51,022) 105,440 (36,529) 1,185,839 (209,570) 101,551 (13,439) 1,080,399 (195,243) 92,639 (13,336)

530,280 (76,780) 130,686 (59,613) 1,204,614 (117,364) 138,805 (21,669) 1,073,928 (110,879) 123,373 (17,032)

<0.01 0.43 >0.99 <0.01 0.87 <0.01

Limongelli et al. 201428

Multiple Systematic review of costs associated with laparoscopic versus open liver resection

Open versus laparoscopic liver resection (9 studies)

USD (converted from various currencies)

Ward stay costs High-dependency unit costs Equipment costs Theater costs Total costs

5,291 5,857 2,207 11,406 23,419

2,972 1,829 3,545 14,538 19,269

NR NR NR NR NR


Table 1-3 Summary of key studies comparing economic outcomes of laparoscopic versus open liver resection Study Setting Study details Procedures Currency

(Cost year) Cost Outcome Open Laparoscopic P value

Medbery et al. 201416

United States

Retrospective record review of elective laparoscopic (n=48) and open (n=57) hepatectomy for both benign and malignant conditions at Emory University Hospital


USD Total operative Operating room Anesthesia Total postoperative PACU Floor ICU Radiology Pathology Laboratory tests Pharmacy Miscellaneous Total overall

10,411 (2,436) 8,708 (2,185) 1,702 (551) 16,341 (14,050) 673 (417) 6,049 (4,421) 2,844 (5,226) 1,165 (2,107) 344 (249) 1,555 (1,691) 2,260 (3,100) 1,450 (2,375) 26,751 (14,574)

16,605 (3,649) 15,287 (3,512) 1,318 (237) 9,075 (6,464) 574 (325) 4,522 (1,936) 1,052 (3,195) 223 (324) 237 (320) 798 (1,279) 1,208 (1,077) 461 (1,039) 25,679 (8,602)

<0.0001 <0.0001 <0.0001 0.001 0.18 0.029 0.041 0.003 0.058 0.012 0.027 0.009 0.65

Vanounou et al. 201029

United States

Deviation-based cost modeling analysis based on n=44 laparoscopic and n=29 open liver resections

Open versus laparoscopic liver resection (2002–2008)

USD (year not states)

Weighted median total hospital costs, all patients Median cost, on course Median cost minor deviation Median cost moderate deviation Median cost major deviation

18,043 17,290 16,201 19,891 24,425

15,104 13,962 14,441 18,648 33,703

NR 0.03 0.31 0.58 0.22

EUR, Euros; JPY, Japanese Yen; SD, standard deviation; SE, standard error; USD, United States dollars

24 Global Value Dossier: Liver Resection 24

1.3. References

1 Jin S, Fu Q, Wuyun G, Wuyun T. Management of post-hepatectomy complications. World J Gastroenterol. 2013;19(44):7983-91. (PMID: 24307791)

2 National Institute for Health and Care Excellence. NICE interventional procedure guidance [IPG135]: Laparoscopic liver resection. Available at https://www.nice.org.uk/guidance/ipg135 [Last accessed 20 December, 2015]

3 Ikoma N, Itano O, Oshima G, Shah SK, Fukuhara S, Kitagawa Y. Laparoscopic Hepatectomy is Easier in Repeat Hepatectomy. CRSLS e2014.00202. DOI: 10.4293/CRSLS.2014.00202.

4 Giulianotti PC, Sbrana F, Coratti A, Bianco FM, Addeo P, Buchs NC, Ayloo SM, Benedetti E. Totally Robotic Right Hepatectomy: Surgical Technique and Outcomes. Arch Surg. 2011;146(7):844−850. (PMID: 21768432)

5 Kim Y, Amini N, He J, Margonis GA, Weiss M, Wolfgang CL, Makary M, Hirose K, Spolverato G, Pawlik TM. National trends in the use of surgery for benign hepatic tumors in the United States. Surgery. 2015;157(6):1055-64. (PMID: 25769697)

6 Wakabayashi G, Cherqui D, Geller DA, Buell JF, Kaneko H, Han HS, Asbun H, OʼRourke N, Tanabe M, Koffron AJ, Tsung A, Soubrane O, Machado MA, Gayet B, Troisi RI, Pessaux P, Van Dam RM, Scatton O, Abu Hilal M, Belli G, Kwon CH, Edwin B, Choi GH, Aldrighetti LA, Cai X, Cleary S, Chen KH, Schön MR, Sugioka A, Tang CN, Herman P, Pekolj J, Chen XP, Dagher I, Jarnagin W, Yamamoto M, Strong R, Jagannath P, Lo CM, Clavien PA, Kokudo N, Barkun J, Strasberg SM. Recommendations for laparoscopic liver resection: a report from the second international consensus conference held in Morioka. Ann Surg. 2015 Apr;261(4):619-29 (PMID: 25742461)

7 Vigano L, Laurent A, Tayar C, et al. The learning curve in laparoscopic liver resection: improved feasibility and reproducibility. Ann Surg 2009;250:772-82 (PMID: 19801926)

8 Troisi RI, Montalti R, Van Limmen JG, Cavaniglia D, Reyntjens K, Rogiers X, De Hemptinne B. Risk factors and management of conversions to an open approach in laparoscopic liver resection: analysis of 265 consecutive cases. HPB (Oxford). 2014 Jan;16(1):75-82 (PMID: 23490275)

9 Parks KR, Kuo YH, Davis JM, O' Brien B, Hagopian EJ. Laparoscopic versus open liver resection: a meta-analysis of long-term outcome. HPB (Oxford). 2014;16(2):109−18. (PMID: 23672270)

10 Rao A, Rao G, Ahmed I. Laparoscopic vs. open liver resection for malignant liver disease. A systematic review. Surgeon. 2012;10(4):194−201. (PMID: 22818276)

11 Cannon RM, Scoggins CR, Callender GG, Quillo A, McMasters KM, Martin RC 2nd. Financial comparison of laparoscopic versus open hepatic resection using deviation-based cost modeling. Ann Surg Oncol. 2013;20(9):2887−92. (PMID: 23636514)

12 Iwahashi S, Shimada M, Utsunomiya T, Imura S, Morine Y, Ikemoto T, Arakawa Y, Mori H, Kanamoto M, Yamada S. Laparoscopic hepatic resection for metastatic liver tumor of colorectal cancer: comparative analysis of short- and long-term results. Surg Endosc. 2014;28(1):80−4. (PMID: 23996337)

13 Kawaguchi Y, Otsuka Y, Kaneko H, Nagai M, Nomura Y, Yamamoto M, Otani M, Ohashi Y, Sugawara K, Koike D, Ishida T, Kokudo N, Tanaka N. Comparisons of financial and short-term outcomes between laparoscopic and open hepatectomy: benefits for patients and

http://www.ncbi.nlm.nih.gov/pubmed/24307791/

https://www.nice.org.uk/guidance/ipg135

http://www.ncbi.nlm.nih.gov/pubmed/21768432


http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+25742461










hospitals. Surg Today. 2015. Online publication ahead of print. doi: 10.1007/s00595-015-1189-0. (PMID: 26021453)

14 Kim H, Suh KS, Lee KW, Yi NJ, Hong G, Suh SW, Yoo T, Park MS, Choi Y, Lee HW. Long-term outcome of laparoscopic versus open liver resection for hepatocellular carcinoma: a case-controlled study with propensity score matching. Surg Endosc. 2014;28(3):950−60. (PMID: 24149856)

15 López-Ben S, Palacios O, Codina-Barreras A, Albiol MT, Falgueras L, Castro E, Figueras J. Pure laparoscopic liver resection reduces surgical site infections and hospital stay. Results of a case-matched control study in 50 patients. Langenbecks Arch Surg. 2014;399(3):307−14. (PMID: 24526221)

16 Medbery RL, Chadid TS, Sweeney JF, Knechtle SJ, Kooby DA, Maithel SK, Lin E, Sarmiento JM. Laparoscopic vs open right hepatectomy: a value-based analysis. J Am Coll Surg. 2014;218(5):929−39. (PMID: 24680574)

17 Shin YC, Jang JY, Kang MJ, Jung W, Chang J, Chang YR, Kim SW. Comparison of laparoscopic versus open left-sided hepatectomy for intrahepatic duct stones. Surg Endosc. 2015. Online publication ahead of print. (PMID: 25861904)

18 Slakey DP, Simms E, Drew B, Yazdi F, Roberts B. Complications of liver resection: laparoscopic versus open procedures. JSLS. 2013;17(1):46−55. (PMID: 23743371)

19 Slim A, Garancini M, Di Sandro S, Mangoni I, Lauterio A, Giacomoni A, De Carlis L. Laparoscopic versus open liver surgery: a single center analysis of post-operative in-hospital and post-discharge results. Langenbecks Arch Surg. 2012;397(8):1305−11. (PMID: 22918605)

20 Wang XT, Wang HG, Duan WD, Wu CY, Chen MY, Li H, Huang X, Zhang FB, Dong JH. Pure Laparoscopic Versus Open Liver Resection for Primary Liver Carcinoma in Elderly Patients: A Single-Center, Case-Matched Study. Medicine (Baltimore). 2015;94(43):e1854. (PMID: 26512595)

21 Xiao L, Xiang LJ, Li JW, Chen J, Fan YD, Zheng SG. Laparoscopic versus open liver resection for hepatocellular carcinoma in posterosuperior segments. Surg Endosc. 2015;29(10):2994−3001. (PMID: 25899815)

22 Luo L, Zou H, Yao Y, Huang X. Laparoscopic versus open hepatectomy for hepatocellular carcinoma: short- and long-term outcomes comparison. Int J Clin Exp Med. 2015 Oct 15;8(10):18772-8 (PMID: 26770494)

23 Zhang Y, Chen XM, Sun DL. Comparison of laparoscopic versus open left lateral segmentectomy. Int J Clin Exp Med. 2015 Jan 15;8(1):904-9 (PMID: 25785073)

24 Siniscalchi A, Ercolani G, Tarozzi G, Gamberini L, Cipolat L, Pinna AD, Faenza S. Laparoscopic versus Open Liver Resection: Differences in Intraoperative and Early Postoperative Outcome among Cirrhotic Patients with Hepatocellular Carcinoma-A Retrospective Observational Study. HPB Surg. 2014;2014:871251. (PMID: 25548432)

25 Kim SJ, Jung HK, Lee DS, Yun SS, Kim HJ. The comparison of oncologic and clinical outcomes of laparoscopic liver resection for hepatocellular carcinoma. Ann Surg Treat Res. 2014 Feb;86(2):61-7 (PMID: 24761410)

26 Ai JH, Li JW, Chen J, Bie P, Wang SG, Zheng SG. Feasibility and safety of laparoscopic liver resection for hepatocellular carcinoma with a tumor size of 5-10 cm. PLoS One. 2013 Aug 21;8(8):e72328 (PMID: 23991092)


















27 Hu BS, Chen K, Tan HM, Ding XM, Tan JW. Comparison of laparoscopic vs open liver lobectomy (segmentectomy) for hepatocellular carcinoma. World J Gastroenterol. 2011 Nov 14;17(42):4725-8 (PMID: 22180716)

28 Limongelli P, Vitiello C, Belli A, Pai M, Tolone S, Del Genio G, Brusciano L, Docimo G, Habib N, Belli G, Jiao LR, Docimo L. Costs of laparoscopic and open liver and pancreatic resection: a systematic review. World J Gastroenterol. 2014;20(46):17595−602. (PMID: 25516675)

29 Vanounou T, Steel JL, Nguyen KT, Tsung A, Marsh JW, Geller DA, Gamblin TC. Comparing the clinical and economic impact of laparoscopic versus open liver resection. Ann Surg Oncol. 2010 Apr;17(4):998-1009 (PMID: 20033324)

© 2016 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. 04/2016 US160332




(MIS) - Medtronic...(mis) global value dossier for minimally invasive surgery (mis) liver resection

Documents

Transcript of (MIS) - Medtronic...(mis) global value dossier for minimally invasive surgery (mis) liver resection