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☆
128
Neoadjuvant
Neoadjuvant/adjuvant/
adjunct therapy (%)
PD (32.2), DP
First line
intervention (%)
radiochemotherapy in
cancer group (90.3)
(14.4), TP (13.2),
NR (40.2)
Whipple’s (100) Adjuvant radiotherapy
(16.3); adjuvant
chemotherapy (43.2):
Gemcitabine alone or in
combination with other
agents (56.3), 5-FU alone
or combined with other
agents (37.5), epirubicin
(6.3)
Drain: Neoadjuvant
chemotherapy (12); no
drain: Neoadjuvant
chemotherapy (9)
PD: With drain
(49.6), no drain
(50.4)
N. E. James et al.
Mean age 61.3±12.1years,
Sample
size Diagnosis (%) Patient characteristics
Germany 174 Malignant pancreatic
Single-centre
(continued)
56.3% male
adenocarcinoma (60.3),
benign tumour (11.5),
retrospective
analysis of
Median age 54years (17–78),
46% male
chronic pancreatitis (28.2)
prospectively
ductal adenocarcinoma
(24.3), other neoplasms
including duodenal
37 Ampullary carcinoma (37.8),
National
Institute of
Medical
Sciences and
gathered data
Single-centre
prospective
cohort
adenocarcinoma,
cholangiocarcinoma,
neuroendocrine tumours,
renal cell metastasis,
malignant GIST,
pseudopapillary tumour
(37.8)
Nutrition
Salvador
Zubiran,
Mexico
Drain: Mean age 62.1years
(11.7), 54% male, BMI 27.8
(7.7), 1%, 14%, 74%, 11%
ASA grades 1 to 4
respectively, mean pancreatic
duct size 3.9mm (1.9); no
drain: Mean age 64.3years
(12.6), 55% male, BMI 27.6
adenocarcinoma (50),
ampullary adenocarcinoma
(10), neuroendocrine
carcinoma (6), pancreatitis
(9) cystic lesion (6), others
(19); no drain: Pancreatic
adenocarcinoma (49),
USA 137 Drain: Pancreatic
Multi-centre
prospective
randomised
controlled trial
(6.1), 10%, 77%, 13% ASA
grades 2–4 respectively, mean
pancreatic duct size 4mm (2)
ampullary adenocarcinoma
(14), neuroendocrine
carcinoma (10), pancreatitis
(7), cystic lesion (6), others
(14)
Author, year
Table 9.1
Belyaev
etal., 2013
of publication Study design Location
Chan etal.,
2012
Van Buren
etal., 2014
9 Patient-Reported Quality ofLife After Pancreatic andLiver Surgery
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
Standard PD
(50.6), PD with
ELND (49.4)
PPPD (63.2), DBP
(36.8)
Whipple’s (50.8),
PPPD (49.2)
PPPD (100) Adjuvant: Intraoperative
radiotherapy (15),
chemotherapy (25)
129
PD: Mean age 64.1years
(32–84), 50% male, mean
maximum dimension of
neoplasm 3.1cm (0.9–4.2);
PD/ELND: Mean age
64.5years (38–80), 54% male,
mean maximum dimension of
neoplasm 3.1cm (1.0–5.8)
adenocarcinoma (95),
nonpancreatic periampullary
neoplasm (2.5), benign
disease (2.5); PD/ELND:
Pancreatic head
adenocarcinoma (87.2),
nonpancreatic periampullary
USA 79 PD: Pancreatic head
Single-centre
randomised
controlled trial
PPPD: Mean age 64years
(10), 59.7% male; DBP: Mean
age 63years (9), 64.3% male
neoplasm (2.6), benign
disease (10.3)
adenocarcinoma (71),
carcinoma of papilla of Vater
(25), cholangiocarcinoma
(4); DBP: pancreatic head
adenocarcinoma (74),
114 PPPD: pancreatic head
The
Netherlands
Single-centre
prospective
cohort
Whipple’s: Median age
65.0years (33–86), 50% male,
62% and 38% of ASA grades
I–II and III–IV respectively;
PPPD: Median age 64.8years
(26–83), 56% male, 73% and
carcinoma of papilla of Vater
(24), cholangiocarcinoma (2)
tumour (73), ampullary
tumour (11), CBD tumour
(12), duodenal tumour (2)
chronic pancreatitis (3);
PPPD: Pancreatic tumour
Switzerland 130 Whipple’s: Pancreatic
Single-centre
prospective
randomised
controlled trial
27% of ASA grades I–II and
III–IV respectively
(61), ampullary tumour (19),
CBD tumour (14), duodenal
Mean age 58.7years, 45%
male
tumour (3), chronic
pancreatitis (3)
ampullary cancer (25),
intraductal papillary
adenocarcinoma (5),
intraductal papillary
adenoma (20), chronic
Japan 20 Pancreatic cancer (25),
Single-centre
prospective
cohort
pancreatitis (15), islet cell
tumour (10)
Farnell
etal., 2005
Nieveen van
Dijkum
etal., 2005
Seiler etal.,
2005
Ohtsuka
etal., 2001
Key: IPMN: intrapapillary mucinous neoplasm, PPPD: pylorus-preserving pancreatoduodenectomy; TP: total pancreatectomy; DP: distal pancreatectomy; PD: pancreaticoduo-
denectomy; DLB: double loop bypass; VR: vein resection; AR: artery resection; VP: palliative therapy with vein adhesion/invasion; AP: palliative therapy with artery adhesion/
invasion; PPD: classical partial pancreaticoduodenectomy; DBP: double bypass procedure; ELA/ELND: extended lymphadenectomy; NR: non-resective surgery; CBD: common
bile duct.
130
N. E. James et al.
Quality scoreTotal duration
94 71 71 557 7– Moderate
Time points (months) of QOL measure post- surgery
(completion rate %)
0.5 1 1.5 3 6 9 12 18 24
Follow-up
pre-surgery
(completion rate %)
QOL instrument(s) used QOL measure
12months
Yes (100) Median
EORTC QLQ-C30
(version 3.0)
EORTC QLQ-PAN26
SF-36
Yes (100) 6months 90 85 80 5– Poor
Yes (79) 2years 64 56 63 67 78 75 60 9– Moderate
(version 3.0)
EORTC QLQ-PAN26
(version 3.0)
EORTC QLQ-PAN26
Not reported 7– Moderate
16.6months
(3.1–58.5)
Yes (100) 2years 88.3 75.1 64.5 51.8 9– Moderate
EORTC QLQ-C30 Yes (56) 2years 53 72 70 58 56 9– Moderate
(Italian version 3.0)
Yes (100) 1year 85 78 57 41 8– Moderate
EORTC QLQ-C30
Yes 2years X X X X 5– Poor
EORTC QLQ-PAN26
VAS pain score
(version 3.0)
EORTC QLQ-PAN26
FACT G
FACT-Hep HCS
Author, year of
publication
Heerkens etal.,
Table 9.2 QOL questionnaires and study quality assessment
2016
Arvaniti etal., 2016 EORTC QLQ-C30
Rees etal., 2013 EORTC QLQ-C30
Walter etal., 2011 EORTC QLQ-C30 Yes (60) 2years 40 X 36 17 X X 9– Moderate
Heinrich etal., 2008 EORTC QLQ-C30 Ye s Median
Wang etal., 2008 EORTC QLQ-C30 Yes (73) 6months 73 57 8– Moderate
Schniewind etal.,
2006
Pezzilli etal., 2011 EORTC QLQ-C30
Kostro and
Śledziński, 2008
Serrano etal., 2015 EORTC QLQ-C30
9 Patient-Reported Quality ofLife After Pancreatic andLiver Surgery
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Quality scoreTotal duration
X X X 7– Moderate
131
Time points (months) of QOL measure post- surgery
(completion rate %)
0.5 1 1.5 3 6 9 12 18 24
Follow-up
pre-surgery
(completion rate %)
QOL instrument(s) used QOL measure
Yes 3months X X X 9– Moderate
EORTC QLQ-C30
EORTC QLQ-PAN26
GIQLI
Yes (100) 2months 100 7– Moderate
Yes (56) 56 8– Moderate
FACT-G
FACT-Pa
FACT-G
Yes (91) 1year 73 51 79 86 92 82 10– High
FACT-Pa
MOS24
GIQLI
RSCL
63.1months
(4–93)
Yes 1year X X X 7– Moderate
questionnaire
Author, year of
publication
Eshuis etal., 2015 EuroQoL- 5D
Nordby etal., 2013 ESAS Yes (84.4) 19weeks 78.1 71.9 7– Moderate
Belyaev etal., 2013 SF-36 Yes (100) 2years 76.4 62.4 9– Moderate
Chan etal., 2012 SF-36 Yes (100) 1year 78 70 82 100 9– Moderate
Van Buren etal.,
2014
Farnell etal., 2005 Uniscale Global QOL
Nieveen van
Dijkum etal., 2005
Seiler etal., 2005 Sickness Impact Prole Median
Ohtsuka etal., 2001 Modied Kurihara’s
Key: EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer core questionnaire; QLQ-PAN26: EORTC pancreatic cancer-specic module; SF-26:
Short Form-36 Health Survey questionnaire; VAS: Visual Analogue Scale; FACT-G: Functional Assessment of Cancer Therapy- General; FACT-Pa: Functional Assessment of
Cancer Therapy- Pancreas; GIQLI: Gastrointestinal Quality of Life Index; ESAS: Edmonton Symptom Assessment System; MOS24: Medical Outcomes Study 24 acute-phase
questionnaire; RSCL: Rotterdam Symptom Checklist.
‘X’ denotes time points post-surgery where patients were given QOL questionnaires to ll in, but completion rates unreported by study authors.
132
Table 9.3 Summary of studies in liver cancer
FACT-HEP EORTC QLQ-C30 SF-36 OTHER Poon (FACT-G)
2001
Liu 2012
Huang 2014
Toro 2012
Miller (FACT-An) 2013
Lee 2019
Chiu 2018
Wang B 2020
Tohme (+FACT –F) 2020
HCC Kamphues
2011
HCC Chie
2015
HCC Dasgupta 2008 LC Fretland
HCC Banz
2009
LC Miller
2013
HCC Ji
2020
HCC Wang J
2019
LC Li
2019
LC
Benign Guiliani
2014
HCC Benzing
2017
2018
Benign & malignant Bruns
(SF-12) 2010
LC Mise
2014
LC Chiu
2018
HCC Liu
2012
LC
Benign Chen
(GQLI) 2004
Ueno 2002
CRLM Tanabe
2001
LC
HCC
HCC
HCC
N. E. James et al.
LC
HCC
HCC
Table 9.4 HRQOL instruments
HRQOL in LR
Study No. Author/Year (Ref)
Poon 2001 PL 66 HCC LR Vs TACE FACT-G Pre, 3, 6, 9,
Huang 2014
Toro 2012 PL/RC 51 HCC LR Vs RFA
PC 346 Small
Pathology Procedure QOL of pts
LR Vs RFA FACT­HCC (<3cm)
Vs TACE Vs
NT
instrument
Hep
FACT­Hep
Time points analyzed (months)
12, 18, 24
Pre, 3, 6, 12, 24, 36
Pre, 3, 6, 12, 24During the rst 12
HRQOL Outcome (P<0.05)
A signicant QOL benet after resection compared to pts. not resected
Perc RFA had signicantly better HRQL total scores after 3, 6, 12, 24 and 36months than LR.
months there was worsening in QoL but by 24months there was marked improvement. After 24months, LR showed a signicant higher QoL than the other groups re physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns. At 24 months there is no difference between minor or major LR.
9 Patient-Reported Quality ofLife After Pancreatic andLiver Surgery
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133
Table 9.4
(continued)
HRQOL in LR
Pathology Procedure QOL
of pts
128 Primary
and
Author/Year (Ref)
Tohme 2020
Study No.
R (secondary)
secondary malignant
Lee 2019 PL 410 HCC LR
Wang 2020
PL 104 Primary
and secondary malignant
Bruns 2010
RC 323 Benign
and malignant
Benzing
RC 66 Lap Vs Open SF-36 HRQOL good with
2017
Giuliani
RC 75 Benign Lap Vs Open SF-36 Pre, 1, 6, 12 At 1 month, no
2014
Time points
LR
instrument
FACT­Hep, FACT-F
analyzed (months)
HRQOL Outcome (P<0.05)
Pre, 4, 8, 12 HRQoL signicantly
decreased from the baseline at 4 months but returned to the baseline at 8 and 12 months. Variables associated with HRQoL at 8 months included extrahepatic recurrence, depressive symptoms, pain, fatigue, tumor macrovascular, and microvascular invasion.
FACT­Hep
Pre, 6, 12, 24ADS had a signicant
negative net effect on QOL, and the differences between ADS and non-ADS groups gradually increased over time.
LR
FACT­Hep
NM There was
improvement in overall QoL, statistically signicant for social/ family well-being.
LR SF-12 3–36 Impact of QoL was
stronger on younger pts. (40–51) (lower PCS & MCS scores). MCS was signicantly higher in LR for metastasis than primary liver ca or benign. High symptoms, pain and deciencies negatively correlated with QoL post op.
no signicant differences in either.
signicance difference. At 6 months better QoL was statistically signicant in Lap Vs open (PF+BP). PF was signicantly better in lap 12months post-op.
(continued)
134
N. E. James et al.
able 9.4
(continued)
Study No.
RCT (substudy)
Pathology Procedure QOL
of pts
273 CRLM Lap Vs Open SF-36 Pre, 1, 4 At 1 month, pts. in
instrument
FACT-G, FACT­Hep
Time points analyzed (months)
Pre, 3, 6 All domains except
HRQOL Outcome (P<0.05)
lap reported reduced scores in PF+RP whereas in open they had reduced scores in PF, RP, BP, V+SF.At 4months lap recovered back to pre-op levels- open still had reduced scores for physical and general health. The open group had signicantly larger change for RP, BP, V+SF at 1 month and RP at 4 months.
PCS in women and in thoracotomy. At 6 months PCS returned to baseline. Improvement in MCS at 6 months compared to pre-op.
BP signicantly improved between preop and third month. Both the PCS and MCS improved signicantly from the preoperative period until the third month after discharge and then remained stable for the rest of 6 months period. Improvement in PCS much bigger than MCS.FACT-Hep/ FACT-G total score signicantly improved at 3 months.
T
HRQOL in LR
Author/Year (Ref)
Fretland 2018
Mise 2014 RC 103 HCC LR SF-36 Pre, 3, 6 At 3 months, lower
Chiu 2018 PL 332 HCC LR SF-36,
9 Patient-Reported Quality ofLife After Pancreatic andLiver Surgery
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135
Table 9.4
(continued)
HRQOL in LR
Study No. Author/Year (Ref)
Liu 2012 PC 64 Advanced
Dasgupta
PL 103 Primary 2008
Pathology Procedure QOL of pts
LR
HCC
(dez+Dex)
LR EORTC and secondary malignant
Kamphues
P 146 Benign LR EORTC
2011
Chie 2015 NR- PL 171 HCC LR Vs TACE
VS RFA VS
NT
instrument
QLQ-C30
QLQ-C30
EORTC QLQ­C30, QLQ­HCC 18
Time points analyzed (months)
HRQOL Outcome (P<0.05)
Pre, 7days PCS+MCS was
signicantly higher in the experimental group post-surgery compared to that of the control group after surgical intervention the body function, psychological function and life function scores were all increased and the difference was statistically signicant for both groups.
Pre, 6, 12, 36Pain and fatigue
showed clinically signicant deterioration over 12 months, which was not statistically signicant. Survivors without recurrence at 36–48 months showed better QOL than those with recurrent disease.
Pre, 17–76 Highly signicant
improved global health status after LR.Remarkable benet in social and emotional functioning after surgery, whereas no impact on physical wellbeing and cognitive functioning. Improvement in 6/9 symptoms esp. pain and fatigue.
Pre, 3 Higher odds of
deterioration in RFA as compared to TACE or LR.
(continued)
136
N. E. James et al.
able 9.4
(continued)
Study No.
of pts
PO 41 Primary
Pathology Procedure QOL
and Malignant
and secondary malignant
T
HRQOL in LR
Author/Year (Ref)
Banz 2009 CS 249 Benign
Miller 2013
instrument
LR EORTC
QLQ­C30, QLQ­LMC21
Major
Hepatectomy
EORTC QLQ­C30, FACT-An
Time points analyzed (months)
26.5months Overall good QOL in
Pre, 1st post-op visit, 6weeks, 3months, 6months
HRQOL Outcome (P<0.05)
LR for malignant. No statistical difference in global QoL scores between malignant or benign. Neither the extent of the resection nor patient age had a signicant inuence on overall QoL.Post­operative diagnosis and poor clinical prognosis did not correlate with QOL.Malignant had a signicantly decreased social function score.
Decreased global QOL, physical functioning, role functioning, and social functioning, along with increased fatigue compared with baseline on 1st post-op visit, normalised at 6weeks’ and remained stable at 6months. Major complications increased severity of pain from baseline over 6 months. Anaemia at the time of discharge had a signicantly worse physical QOL at 6weeks following surgery, which returned to similar levels as for non-anemic patients at 3months.
9 Patient-Reported Quality ofLife After Pancreatic andLiver Surgery
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137
Table 9.4
(continued)
HRQOL in LR
Study No. Author/Year (Ref)
Ji 2020 P
(randomized)
Pathology Procedure QOL of pts
84 Primary
and
secondary
malignant
Wang
RCT 136 HCC LR (CEC Vs
2019
Li 2019 PC 128 Primary
and
secondary
malignant
LR (High Quality Nursing Vs Basic)
Basic)
LR Vs TACE/TAE Vs RFA
instrument
EORTC QLQ-C30
EORTC QLQ-C30
EORTC QLQ-30
Time points analyzed (months)
HRQOL Outcome (P<0.05)
NM The experimental
group was better than the control group in terms of physical function, emotional function, role function and social function.
Pre, 3, 6,9, 12Global health status
and functional score was increased at 12mo, and score improvement from baseline was greater in CEC group compared with control group.
Pre, 1, 3, 6 LR or RFA were at
signicant risk of a decrease in physical function than those who received TAE/ TACE from baseline to 1 month. LR Vs RFA resulted in an improvement in the patients’ cognitive function from baseline to 6months.
(continued)
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