SENTI-ENDO
Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO)
Phase observationalN = 133NCT00987051
- Population
- Patients with FIGO stage I-II endometrial cancer
- Design
- Prospective, multicentre cohort study at nine centres in France. Patients with FIGO stage I-II endometrial cancer had pelvic sentinel lymph-node assessment by cervical dual injection (technetium and patent blue) followed by systematic pelvic-node dissection as the reference. All nodes were examined histopathologically and sentinel nodes were serially sectioned and examined by immunochemistry. The primary endpoint was the negative predictive value of sentinel-node biopsy per hemipelvis. 133 patients were enrolled from 5 July 2007 to 4 August 2009; at least one sentinel node was detected in 111 of the 125 eligible patients. This was a non-randomised study with no survival endpoint.
- Primary endpoint
- Sentinel-node negative predictive value
- Arms
- Sentinel-node biopsy then pelvic lymphadenectomy (experimental): Pelvic sentinel lymph-node assessment (cervical dual injection of technetium and patent blue) followed by systematic pelvic-node dissection as the reference standard
- People
- Ballester M
Show the numbers
| Endpoint | Analysis | Sentinel-node biopsy then pelvic lymphadenectomy | Control | Effect |
|---|---|---|---|---|
| Sentinel-node negative predictive valueUnit of analysis: hemipelvis | primaryBallester 2011 | 100% (95–100%) | — | — |
| Sentinel-node sensitivityUnit of analysis: hemipelvis | primaryBallester 2011 | 100% (63–100%) | — | — |
| Sentinel-node negative predictive valueUnit of analysis: patient | primaryBallester 2011 | 97% (91–99%) | — | Three patients had false-negative results (two had metastatic nodes in the contralateral pelvic area and one in the para-aortic area); all three had type 2 endometrial cancer (abstract). |
| Sentinel-node sensitivityUnit of analysis: patient | primaryBallester 2011 | 84% (62–95%) | — | — |
| Endpoint | Analysis | Sentinel-node biopsy then pelvic lymphadenectomy | Control | Effect |
|---|---|---|---|---|
| Sentinel-node negative predictive valueUnit of analysis: hemipelvis | primaryBallester 2011 | 100% (95–100%) | — | — |
| Sentinel-node sensitivityUnit of analysis: hemipelvis | primaryBallester 2011 | 100% (63–100%) | — | — |
| Sentinel-node negative predictive valueUnit of analysis: patient | primaryBallester 2011 | 97% (91–99%) | — | Three patients had false-negative results (two had metastatic nodes in the contralateral pelvic area and one in the para-aortic area); all three had type 2 endometrial cancer (abstract). |
| Sentinel-node sensitivityUnit of analysis: patient | primaryBallester 2011 | 84% (62–95%) | — | — |