Diagnostic Test Accuracy Review

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Laparoscopy for diagnosing resectability of disease in patients with advanced ovarian cancer

  1. Marianne J Rutten1,
  2. Mariska MG Leeflang2,
  3. Gemma G Kenter3,
  4. Ben Willem J Mol4,
  5. Marrije Buist3,*

Editorial Group: Cochrane Gynaecological, Neuro-oncology and Orphan Cancer Group

Published Online: 21 FEB 2014

Assessed as up-to-date: 1 FEB 2013

DOI: 10.1002/14651858.CD009786.pub2


How to Cite

Rutten MJ, Leeflang MMG, Kenter GG, Mol BWJ, Buist M. Laparoscopy for diagnosing resectability of disease in patients with advanced ovarian cancer. Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.: CD009786. DOI: 10.1002/14651858.CD009786.pub2.

Author Information

  1. 1

    Academic Medical Center, Department of Obstetrics and Gynaecology, Amsterdam, Netherlands

  2. 2

    Academic Medical Center, University of Amsterdam, Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam, Netherlands

  3. 3

    Academic Medical Center Amsterdam, Gynaecology, Amsterdam, Netherlands

  4. 4

    The University of Adelaide, Discipline of Obstetrics and Gynaecology, School of Medicine, Robinson Research Institute, Adelaide, South Australia, Australia

*Marrije Buist, Gynaecology, Academic Medical Center Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, Netherlands. m.r.buist@amc.nl. mrbuist@gmail.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 21 FEB 2014

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Characteristics of included studies [ordered by study ID]
Angioli 2005

Study characteristics

Patient samplingRetro- or prospective enrolment not known


Patient characteristics and settingSample size: 87 patients
Mean age: 58 years (range 19-79)
Presentation: Patients with primary ovarian cancer FIGO Stage IIIC/IV, good nutrition status, WHO < 2, no contraindications for surgery, evaluation for optimal primary debulking surgery (RT = 0)

Diagnostics before index test: physical/gynaecological examination, ultrasonography, CA 125, CT abdomen/pelvis, Thorax x-ray/CT

Kind of surgery: PDS 53; IDS 25: No debulking surgery: 9

Setting: Department of gynaecology, University hospital Rome, Italy


Index testsOpen diagnostic laparoscopy; examination of the whole abdominal cavity, biopsies for frozen section, performed by gynaecological oncologist. If judged resectable direct cytoreduction                          

Cut-off test-positivity: prediction of complete absence of disease after cytoreduction

Complications of index test: trocar metastasis 2 cases (6%), intraoperative complication 1 (3%)


Target condition and reference standard(s)Target condition: possibility of leaving no macroscopic disease at debulking surgery                                 

Criteria for target condition: extensive peritoneal carcinomatosis/involvement of bowel mesentery/bulky disease diaphragm/ multiple liver metastases/heavily bleeding tumoral tissue Reference standard: Laparotomy.Test operators: gynaecological oncologist Percentage of patients reference standard performed: 61% Unresectable disease at laparotomy: 2


Flow and timingTime between reference standard and Index test: 0 day.


Comparative


Notes87 patients had a laparoscopy, 53 where indicated to be operable. Of these 51 had operable disease at laparotomy and 2 not. The other 34 patients were treated with NACT and 25 received an interval debulking surgery after 3 courses of chemotherapy.


Methodological quality

ItemAuthors' judgementRisk of biasApplicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?Yes
Did the study avoid inappropriate exclusions?Yes
Were the patients suspected of advanced ovarian cancer by conventional diagnostic work-up?Yes
Were patients planned for primary cytoreductive surgery after conventional diagnostic work-up?Yes
Low

DOMAIN 2: Index Test Diagnostic open laparoscopy

Were the index test results interpreted without knowledge of the results of the reference standard?Yes
If a threshold was used, was it pre-specified?No
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?No
Did the study provide a clear definition of what was considered to be a "positive "result for the index test?No
Low

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?No
Low

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?Yes
Were all patients included in the analysis?Yes
Did patients receive the same reference standard regardless of the index test result?No

Brun 2008

Study characteristics

Patient samplingRetrospective study


Patient characteristics and settingSample size: 55 patients
Diagnostics before index test: physical/gynaecological examination, abdominal ultrasound, CA125, CT abdomen/pelvis, thorax x-ray/CT, routine blood test.
Mean age: 61 years; (range 21-88)
Presentation: Patients suspected of ovarian cancer FIGO III-IV without contraindication for surgery
Kind of surgery: 26 patients PDS

Setting: Hospital Tenon, France.


Index testsDiagnostic laparoscopy; examination of uterus and ovaries, peritoneal surfaces, paracolic gutters, small bowel and mesentery, liver surface, omentum, diaphragm, large bowel.

Cut-off test-positivity: PIV of 8 or more

Complications of index test: none reported


Target condition and reference standard(s)Target condition: residual disease of more than 1 cm after surgery

Criteria for target condition: no extensive peritoneal carcinomatosis/ involvement of bowel mesentery/bulky disease diaphragm/unresectable upper abdomen metastases

Reference standard: Laparotomy.

Test operators: gynaecological oncologist

Percentage of patients reference standard performed: 26/55

Unresectable disease at laparotomy: 8 (of 26 operated) (29 NACT)


Flow and timingReference standard performed after index test, time between treatment not mentioned


Comparative


NotesRetrospective external validation of the prediction model of Fagotti 2006. This was done in the same population as described in Brun 2009.


Methodological quality

ItemAuthors' judgementRisk of biasApplicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?Unclear
Did the study avoid inappropriate exclusions?Unclear
Were the patients suspected of advanced ovarian cancer by conventional diagnostic work-up?Yes
Were patients planned for primary cytoreductive surgery after conventional diagnostic work-up?Yes
Low

DOMAIN 2: Index Test Diagnostic open laparoscopy

Were the index test results interpreted without knowledge of the results of the reference standard?Yes
If a threshold was used, was it pre-specified?Yes
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?Yes
Did the study provide a clear definition of what was considered to be a "positive "result for the index test?Yes
Low

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?No
Low

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?Unclear
Were all patients included in the analysis?No
Did patients receive the same reference standard regardless of the index test result?No

Brun 2009

Study characteristics

Patient samplingRetrospective study


Patient characteristics and settingSample size: 55 patients
Mean age: 62 years (range 21-88)
Presentation: Patients with primary ovarian cancer FIGO stage III/IV, no contraindication for surgery or malnutrition, evaluation for PDS

Diagnostics before index test: physical/gynaecological examination, CA 125, CT abdomen/pelvis, Thorax x-ray/CT, routine blood test

Kind of surgery: PDS 26; IDS 26: No debulking surgery 3

Setting: Department of gynaecology hospital Tenon, Paris, France.


Index testsOpen diagnostic laparoscopy performed by 7 surgeons, 3 gynaecological oncologists, 4 non-gynaecological surgeons. Frozen section of tumour/metastasis. In case of operability direct cytoreduction by laparotomy

Cut-off test-positivity: absence of visible residual tumour was considered feasible

Complications of index test: 1 trocar metastasis occurred in PDS group (2%)


Target condition and reference standard(s)Target condition: macroscopic residual tumour.

Criteria for target condition: extensive peritoneal carcinomatosis/involvement of bowel mesentery/bulky disease diaphragm/unresectable upper abdomen metastases.

Reference standard: Laparotomy.

Test operators: gynaecological oncologists and general gynaecologists.

Percentage of patients in whom reference standard performed: 47%

Unresectable disease at laparotomy: 12


Flow and timingTime between reference standard and Index test: 0 day


Comparative


NotesSame population as Brun 2008. 52 patients had a diagnostic laparoscopy. 26 of these patients were considered suitable for laparotomy. However 8 had more than 1 cm of residual disease left after laparotomy. The other 26 patients received NACT and interval debulking surgery. Cytoreduction only when absence of visible residual tumour was considered feasible.


Methodological quality

ItemAuthors' judgementRisk of biasApplicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?Unclear
Did the study avoid inappropriate exclusions?Unclear
Were the patients suspected of advanced ovarian cancer by conventional diagnostic work-up?Yes
Were patients planned for primary cytoreductive surgery after conventional diagnostic work-up?Yes
Low

DOMAIN 2: Index Test Diagnostic open laparoscopy

Were the index test results interpreted without knowledge of the results of the reference standard?Yes
If a threshold was used, was it pre-specified?Unclear
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?Yes
Did the study provide a clear definition of what was considered to be a "positive "result for the index test?Yes
Low

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?No
Low

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?Yes
Were all patients included in the analysis?Unclear
Did patients receive the same reference standard regardless of the index test result?No

Deffieux 2006

Study characteristics

Patient samplingcross-sectional study, enrolment not reported


Patient characteristics and settingSample size: 15 patients
Mean age: 54 years (range 37-75)
Presentation: Patients with primary ovarian cancer FIGO stageIIIC/IV suspected of peritoneal carcinomatosis and in whom preoperative evaluation was unsatisfactory to define the possibility of achieving a complete cytoreduction, no massive disease at diaphragm/xiphoid or liver pedicle, planned for PDS

Diagnostics before index test: physical/gynaecological examination, CT abdomen/pelvis, Thorax x-ray/CT,

Kind of surgery: PDS 11; IDS 0 No debulking surgery 4

Setting: Department of gynaecology hospital Tenon, Paris, France


Index testsOpen diagnostic laparoscopy; examination of the whole abdomen, focus on involvement of small bowel, liver pedicle and upper right diaphragmatic dome. Cut-off test-positivity: having one or more of the criteria for unresectability

Complications of index test: none


Target condition and reference standard(s)Target condition: unresectable carcinomatosis

Criteria for target condition: involvement of bowel mesentery/bulky disease diaphragm/massive involvement of liver pedicle

Reference standard: Laparotomy.

Test operators: not reported

Percentage of patients in whom reference standard performed:73%

Unresectable disease at laparotomy: 1


Flow and timingTime between reference standard and index test: 0 day.


Comparative


Notes15 patients underwent diagnostic laparoscopy, of these 11 were considered operable. Ten of the patients were indeed successfully operated and one had too extensive disease. The other four patients were treated with NACT.


Methodological quality

ItemAuthors' judgementRisk of biasApplicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?Unclear
Did the study avoid inappropriate exclusions?Unclear
Were the patients suspected of advanced ovarian cancer by conventional diagnostic work-up?Yes
Were patients planned for primary cytoreductive surgery after conventional diagnostic work-up?Yes
Low

DOMAIN 2: Index Test Diagnostic open laparoscopy

Were the index test results interpreted without knowledge of the results of the reference standard?Yes
If a threshold was used, was it pre-specified?Yes
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?Yes
Did the study provide a clear definition of what was considered to be a "positive "result for the index test?Yes
Low

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?No
Low

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?Yes
Were all patients included in the analysis?Yes
Did patients receive the same reference standard regardless of the index test result?No

Fagotti 2004

Study characteristics

Patient samplingProspective study


Patient characteristics and settingSample size: 64 patients
Mean age: 57.4 years (+/- 12,7)
Presentation: Patients undergoing surgery for a suspected advanced ovarian or peritoneal cancer, exclusion advanced ASA or very large mass reaching xiphoid/occupying the abdominal wall or cavity. Included also if on radiologic and clinical criteria suspected of unresectable disease.

Diagnostics before index test: physical/gynaecological examination, ultrasonography, CA 125, CT abdomen/pelvis, Thorax x-ray/CT

Kind of surgery: All patients received explorative laparotomy. Performed before: PDS 42; IDS 19: recurrence: 3


Index testsOpen diagnostic laparoscopy, investigating frozen pelvis, omental cake, diaphragmatic or peritoneal extensive carcinomatosis, tumour diffusion to the large and small curvature of the stomach, large and/or small bowel mesentery disease, spleen and/or liver metastases, bulky lymph nodes.

Cut-off test-positivity: absence of criteria for un resectability

Complications of index test: none


Target condition and reference standard(s)Target condition: resectability of tumour residual of less than 1 cm not possible Criteria for target condition: extensive peritoneal carcinomatosis/involvement of bowel mesentery/bulky disease diaphragm/ portal triad disease/unresectable upper abdominal metastasis

Reference standard: Explorative laparotomy.

Test operators: not reported percentage of patients

Reference stand performed: 100%

Unresectable disease at laparotomy: 23


Flow and timingTime between reference standard and index test: 0 day.


Comparative


NotesNot only patients planned for primary surgery, but also planned for IDS or secondary surgery because of recurrence. After inclusion and laparotomy FIGO I-II, III-IV 9-42 respectivily, 6 benign, 7 other tumour


Methodological quality

ItemAuthors' judgementRisk of biasApplicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?Yes
Did the study avoid inappropriate exclusions?Yes
Were the patients suspected of advanced ovarian cancer by conventional diagnostic work-up?Yes
Were patients planned for primary cytoreductive surgery after conventional diagnostic work-up?No
High

DOMAIN 2: Index Test Diagnostic open laparoscopy

Were the index test results interpreted without knowledge of the results of the reference standard?Yes
If a threshold was used, was it pre-specified?Yes
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?Yes
Did the study provide a clear definition of what was considered to be a "positive "result for the index test?Yes
Low

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?No
Low

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?Yes
Were all patients included in the analysis?No
Did patients receive the same reference standard regardless of the index test result?Yes

Fagotti 2008

Study characteristics

Patient samplingProspective study


Patient characteristics and settingSample size: 113 patients
Diagnostics before index test: physical/gynaecological examination, CA 125, CT abdomen/pelvis, Thorax x-ray/CT, Performance status
Mean age: 59 years (range 34-81)
Presentation: Patients suspected of advanced primary ovarian cancer
Kind of surgery: primary (91) or interval debulking (22) surgery

Setting: Division of Gynaecologic Oncology, University hospital, Rome, Italy


Index testsEight laparoscopic features investigated as potential indicators of surgical outcome; presence of ovarian masses, omental cake, peritoneal carcinomatosis, diaphragmatic carcinosis, mesenteric retraction, bowel infiltration, stomach infiltration, liver metastases.

Cut-off test-positivity: PIV 8 or more ( based on presence of criteria)

Complications of index test: none


Target condition and reference standard(s)Target condition: possibility of leaving less than 1 cm macroscopic disease at debulking surgery

Criteria for target condition: no extensive peritoneal carcinomatosis/no involvement of bowel mesentery/no bulky disease diaphragm/ no unresectable upper abdomen metastases, good performance status

Reference standard: Laparotomy.

Test operators: gynaecological oncologist

Percentage of patients in whom reference standard performed: 100%

Unresectable disease at laparotomy: 50%


Flow and timingTime between ref standard and indextest not mentioned


Comparative


NotesValidation of prediction model developed by Fagotti 2006 in prospective cohort. Also patients planned for IDS included in study. Primary and interval debulking patients were not separately analysed.


Methodological quality

ItemAuthors' judgementRisk of biasApplicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?Yes
Did the study avoid inappropriate exclusions?Yes
Were the patients suspected of advanced ovarian cancer by conventional diagnostic work-up?Yes
Were patients planned for primary cytoreductive surgery after conventional diagnostic work-up?No
High

DOMAIN 2: Index Test Diagnostic open laparoscopy

Were the index test results interpreted without knowledge of the results of the reference standard?Yes
If a threshold was used, was it pre-specified?Yes
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?Yes
Did the study provide a clear definition of what was considered to be a "positive "result for the index test?Yes
Low

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?Unclear
Low

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?Yes
Were all patients included in the analysis?Yes
Did patients receive the same reference standard regardless of the index test result?Yes

Vergote 1998

Study characteristics

Patient samplingRetrospective study design


Patient characteristics and settingSample size: 77
Diagnostics before index test: radiological examination
Mean age: not mentioned
Presentation: Patients with obvious metastatic disease of ovarian cancer on radiological examination, planned for PDS
Kind of surgery: Primary debulking in 28 patients, IDS 31, 18 no surgery

Setting: Division of Gynaecologic Oncology, University hospital, Brussels, Belgium


Index testsDecision to give NACT of primary debulking with the help of an open laparoscopy

Cut-off test-positivity: not reported

Complications of index test: two port site metastases (3%)


Target condition and reference standard(s)Target condition: unresectability leaving more than 0.5 cm of residual tumour

Criteria for target condition: not mentioned

Reference standard: Explorative laparotomy.

Test operators: not reported

Percentage of patients in whom reference standard performed: 36% (28 patients)

Unresectable disease at laparotomy: 21% (6 patients)


Flow and timingTime between ref standard and indextest not mentioned


Comparative


NotesDecision to give NACT or PDS in all patients with advanced ovarian cancer, subgroup in paper about NACT or PDS retrospectively. 77 patients had a diagnostic laparoscopy. Of these 28 underwent a laparotomy and 21 had resectable disease. 49 patients received NACT and IDS.


Methodological quality

ItemAuthors' judgementRisk of biasApplicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?Yes
Did the study avoid inappropriate exclusions?No
Were the patients suspected of advanced ovarian cancer by conventional diagnostic work-up?Yes
Were patients planned for primary cytoreductive surgery after conventional diagnostic work-up?Yes
Low

DOMAIN 2: Index Test Diagnostic open laparoscopy

Were the index test results interpreted without knowledge of the results of the reference standard?Yes
If a threshold was used, was it pre-specified?No
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?Yes
Did the study provide a clear definition of what was considered to be a "positive "result for the index test?No
High

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?No
Low

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?Yes
Were all patients included in the analysis?Yes
Did patients receive the same reference standard regardless of the index test result?No

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Batka 1993Different outcome

Bristow 2006No original data shown

Bruhat 1981No original data shown

Brun 2009aDuplicate data; abstract of congress

Dagnini 1987Different outcome

Fagotti 2006Duplicate data; development of prediction model in study population of Fagotti 2004, which is included in the review

Gurrea 2010No data about evaluation of resectability

Nezhat 2010No data about evaluation of resectability

Vergote 2003No original data shown

 
Characteristics of ongoing studies [ordered by study ID]
Rutten 2012

Trial name or titleLaparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study

Target condition and reference standard(s)target condition is residual disease > 1 cm; reference standard is laparotomy

Index and comparator testsLaparoscopy

Starting dateMay 2011

Contact informationlapovca@studies-obsgyn.nl

Notes

 
Tests. Data tables by test

TestNo. of studiesNo. of participants

 1 Laparoscopy1179

 2 PIV ≥ 8 to diagnose unresectable disease2168