01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Gamma probe and ultrasound guided fine needle aspiration cytology of the sentinel node (GULF) trial - overview of the literature, pilot and study protocol
- Zeitschrift:
- BMC Cancer > Ausgabe 1/2017
Electronic supplementary material
Background
Sentinel node biopsy
Ultrasound guided fine needle aspiration cytology
Literature overview
Author, year
|
Study Design
|
N
|
US Setting
|
FNAC/other technique
|
Sens (%)
|
Spec (%)
|
PPV (%)
|
NPV (%)
|
---|---|---|---|---|---|---|---|---|
Rossi [
61], 2000
|
Not mentioned
|
69
|
Pre-lympho
|
No
|
33
|
100
|
100
|
86
|
Rossi [
25], 2003
|
Prospective, monocentric
|
125
|
Pre-lympho
|
FNAC if US suspicious
|
US alone: Not mentioned
|
-
|
-
|
-
|
US-FNAC: 39
|
100
|
100
|
85
|
|||||
Hocevar [
62], 2004
|
Prospective, monocentric
|
57
|
unknown
|
FNAC if US suspicious
|
US alone: 71
|
84
|
59
|
90
|
US-FNAC: Not mentioned
|
-
|
-
|
-
|
|||||
Testori [
63], 2005
|
Retrospective, monocentric
|
88
|
unknown
|
No
|
94
|
90
|
64
|
99
|
Starritt [
64], 2005
|
Prospective, monocentric
|
31 all SN +
|
Post-lympho
|
No
|
NA
|
NA
|
NA
|
NA
|
Voit [
65], 2006
|
Prospective, monocentric
|
127
|
Post-lympho
|
FNAC if US suspicious
|
US alone: 79
|
72
|
53
|
90
|
FNAC alone: 59
|
100
|
100
|
85
|
|||||
US-FNAC: 82
|
72
|
54
|
91
|
|||||
Van Rijk [
26], 2006
|
Retrospective, monocentric
|
107
|
Pre-lympho
|
FNAC if US suspicious
|
US alone: 34
|
87
|
-
|
-
|
US-FNAC: 4.7
|
100
|
-
|
-
|
|||||
Sibon [
66], 2007
|
Prospective, monocentric
|
131
|
Pre-lympho
|
No
|
9
|
96
|
43
|
-
|
Kunte [
67], 2009
|
Prospective, monocentric
|
25
|
Pre- and post-lympho
|
No
|
33
|
100
|
100
|
88
|
Voit [
30], 2009
|
Prospective, monocentric
|
400
|
Post-lympho
|
FNAC if US suspicious
|
65
|
99
|
93
|
92
|
Sanki [
60], 2009
|
Prospective, monocentric
|
716
|
Post-lympho
|
No
|
33
|
97
|
60
|
88
|
De Giorgi [
36], 2010
|
Prospective monocentric
|
15
|
Post-lympho
|
Standard CEUS
|
CEUS: 100
|
62
|
55
|
100
|
Voit [
31], 2010
|
Prospective monocentric
|
400
|
Post lympho
|
FNAC if US suspicious
|
All Berlin criteria combined: 82
|
80
|
52
|
94
|
Hinz [
58], 2011
|
Prospective monocentric
|
81
|
Pre and post lympho
|
No
|
22
|
100
|
100
|
96
|
Chai [
68], 2012
|
Retrospective monocentric
|
325
|
Pre-lympho
|
FNAC if US suspicious
|
34
|
86
|
37
|
84
|
Marone [
69], 2012
|
Prospective monocentric
|
623
|
Pre-lympho
|
No
|
15
|
100
|
100
|
87
|
Pilko [
70], 2012
|
Retrospective Monocentric
|
405
|
Pre-lympho
|
FNAC if US suspicious
|
Not mentioned
|
-
|
-
|
-
|
Stoffels [
71], 2012
|
Retrospective Monocentric
|
221
|
Pre-lympho
|
FNAC if US suspicious
|
14
|
97
|
100
|
97
|
Hinz [
72], 2013
|
Retrospective Monocentric
|
20
|
Pre-lympho &, pre PET-CT
|
No If US malig. Direct LND
|
12
|
100
|
100
|
74
|
Ulrich [
73], 2014
In German
|
Prospective monocentric
|
800
|
Post lympho
|
FNAC if US suspicious
|
US-FNAC: 56
|
99
|
92
|
89
|
Voit [
32], 2014
|
Prospective monocentric
|
1000
|
Post lympho
|
FNAC if US suspicious
|
US alone: 71
|
-
|
-
|
-
|
US-FNAC: 51
|
99
|
99
|
89
|
|||||
Voit [
33], 2016
|
Prospective monocentric
|
1000
|
Post lympho
|
FNAC if US suspicious
|
US alone: 71
|
-
|
-
|
-
|
US-FNAC: 51
|
99
|
99
|
89
|
Author, yr
|
Topic
|
No. of patients
|
Technique
|
Sens (%)
|
Spec (%)
|
---|---|---|---|---|---|
Hinz [
72], 2013
|
Elastography
|
36
|
US + power Doppler:
|
81
|
76
|
Elastography:
|
91
|
76
|
|||
Combined:
|
95
|
76
|
|||
Ogata [
35], 2014
|
Elastography
|
12
|
US:
|
77
|
57
|
Elastography:
|
100
|
71
|
|||
Stoffels [
37], 2015
|
MSOT and indocyanin green
|
20
|
MSOT
|
100
|
48.6
|
Rationale for a new trial
SN identification
Cytology or histology?
Hypotheses GULF trial
Study aims
-
To present a study protocol for a minimally invasive alternative to the sentinel node biopsy (GULF trial), with as primary objective to determine whether an acceptable sensitivity for US and gamma probe guided FNAC can be achieved.
-
Secondary objective is 1) the identification rate of the SN and 2) the histological results of CNB versus FNAC and versus SNB.