Barranger 2009.

Study characteristics
Patient Sampling	Country: France Study design: a prospective study of 33 consecutive patients with endometrial cancer from July 2002 to October 2005. Inclusion criteria: biopsy‐confirmed endometrial cancer of apparent stage I or II according to the preoperative criteria of the FIGO. Exclusion criteria: not reported.
Patient characteristics and setting	Number of patients: 33 Median age: 66.1 years (range, 46‐84 years) Median body mass index: 25.8 kg/m2 (range, 17.8 ‐ 36.9 kg/m2) Histopathological cell type: endometrioid adenocarcinoma = 29 (87.9%), adenosquamous carcinoma = 1 (3%), clear cell carcinoma = 2 (6.1%), malignant mixed Muellerian tumour = 1 (3%) 1988 FIGO stage: Ia = 4 (12.1%), Ib = 13 (39.4%), Ic = 13 (39.4%), II = 3 (9.1%). Grade on hysterectomy specimen: for endometrial adenocarcinoma, grade 1 = 18 (54.5%), grade 2 = 9 (27.3%), and grade 3 = 2 (6.1%) Lymphovascular space involvement: not reported.
Index tests	Type of endometrial sampling: diagnosis confirmed by biopsy. Experience of operator: not reported Tracer used and amount: 0.2 mL of unfiltered technetium sulfur colloid, 2 mL of patent blue Method and timing of application: all patients received four pericervical injections (1.5 cm depth) of 0.2 mL (10 MBq each) of unfiltered technetium sulfur colloid (Nanocis; CIS Bio International, Saclay, France) administered with a 25‐G spinal needle on the day before surgery. All patients received Patent blue dye injected pericervically (1mL per injection, 1.5 cm deep) with a 25‐G spinal needle at 3 and 9 o’ clock. Grossly metastatic nodes were sectioned. Normal‐appearing SNs were cut perpendicular to the long axis. All SNs were examined intraoperatively by imprint cytology for the pathologist learning curve. Air‐dried cytologic smears were prepared by scraping the cut surfaces and were stained by using a rapid May‐Grünwald‐Giemsa method. Each half‐SN was sectioned at 3‐mm intervals. Each 3‐mm section was analysed by 4 additional levels of 150 µm and 4 parallel sections; 1 section was used for haematoxylin and eosin (H&E) staining, and H&E‐negative sections were then examined by immunohistochemistry with an anticytokeratin antibody cocktail (Cytokeratin AE1‐AE3; Dako Corporation, Glostrup, Denmark). Non‐SNs were totally submitted and blocked individually following 3‐mm distances and H&E staining.
Target condition and reference standard(s)	Type: patients with stage I‐II endometrial cancer all underwent pelvic +/‐ para‐aortic lymphadenectomy performed to the level of the aortic bifurcation. Patients with clinical stage I disease underwent laparoscopic treatment, including peritoneal washing, bilateral salpingo‐oophorectomy, the SN procedure, systematic pelvic lymphadenectomy, and laparoscopically assisted vaginal hysterectomy. Patients with apparent stage II disease underwent a peritoneal washing, bilateral salpingo‐oophorectomy, SN procedure followed by systematic pelvic lymphadenectomy and laparoscopic radical hysterectomy. Lymph node number and site: At least 1 SN was identified in only 27 patients (81.8%). The mean number of SNs was 2.5 per patient (range, 1‐5). A total of 71 SNs was removed. 18 patients (54.5%) had an identified bilateral SN. The most common site of the SNs was the medial external iliac region (67.6%). Other sites included intermediate external iliac region (2.8%), obturator fossa (5.6%), interiliac area (19.7%), common iliac region (2.8%), and aortic bifurcation (1.4%).
Flow and timing	All patients received the index and reference standard within 1 month. Patients did not all receive the same reference standard, as 90.9% received laparoscopy‐assisted vaginal hysterectomy and 9.1% received laparoscopic radical hysterectomy. All patients underwent systemic pelvic lymph node dissection. Para‐aortic lymph node dissection was only performed if a para‐aortic SN was detected. None of the patients required para‐aortic lymph node dissection, as no para‐aortic SN was detected. All patients were included in the analysis.
Comparative
Notes	Study results: Total number of SNs removed was 71. SN were identified in only 27 patients (81.8%). Mean number of SNs was 2.5/patient. 54.5% had bilateral SNs detected. No false‐negative SLNs were reported. Fourteen SNs (19.7%) from 8 patients were found to be metastatic at the final histological assessment. Sensitivity, specificity and true positives are not reported. TP = 8; FP = 0; FN = 0; TN ‐ 19; Failed = 6. FIGO Stage (converted to 2009 classification) Ia = 17; IB+ = 16. Type 1 & 2 tumours. Cervical injections; 18 patients with bilateral detection. Adverse reaction from index or reference test: no anaphylactic reactions to patent blue occurred. Operating time: median of 160.2 minutes (range, 120‐280). Other intraoperative complications: No intraoperative complications occurred. Other postoperative complications: not reported.
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Yes
Was a case‐control design avoided?	Yes
Did the study avoid inappropriate exclusions?	Unclear
Could the selection of patients have introduced bias?		Unclear risk
Are there concerns that the included patients and setting do not match the review question?			Low concern
DOMAIN 2: Index Test (All tests)
Were the index test results interpreted without knowledge of the results of the reference standard?	Unclear
If a threshold was used, was it pre‐specified?	Yes
Could the conduct or interpretation of the index test have introduced bias?		Unclear risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Low concern
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
Could the reference standard, its conduct, or its interpretation have introduced bias?		Unclear risk
Are there concerns that the target condition as defined by the reference standard does not match the question?			Low concern
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Yes
Did all patients receive the same reference standard?	No
Were all patients included in the analysis?	Yes
Could the patient flow have introduced bias?		Unclear risk