Early-stage ovarian tumors represent approximately 30% of all newly diagnosed ovarian cancers. Current international guidelines recommend random peritoneal biopsies for surgical staging, but the diagnostic yield of these biopsies remains limited. The PONDER study aims to evaluate whether standardized surgical procedure and pathology assessment of wider peritoneal pelvic biopsies can increase the detection rate of microscopic peritoneal implants and micrometastases in patients with early-stage ovarian tumors. This multicenter, prospective, single-arm study includes both minimally invasive and open surgical approaches, with a standardized gross and microscopic evaluation of the resected peritoneal specimens
The study focuses on the excision of anatomically defined pelvic peritoneal areas, with meticulous dissection of the retroperitoneal spaces and a nerve-sparing approach. Combined with a specific pathology protocol, this strategy improves the detection of microscopic peritoneal involvement and provides new insights into the mechanisms of pelvic recurrence
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
390
Surgical Procedure: Initial step: Exclude upper abdominal disease through inspection and guideline-based biopsies. Pelvic peritoneal resection: En bloc or segmental removal of predefined pelvic peritoneal regions according to dissection of retroperitoneal spaces with a nerve-sparing technique.
Fixation: 10% neutral-buffered formalin for 6-48 hours. Processing: Paraffin eembedding and complete sampling for histology. Staining: H\&E and immunohistochemistry (MOC-31, BER-EP4) to identify epithelial tumor cells. Reporting: Checklist for peritoneal disease
Azienda Ospedaliera Santa Croce e Carle Cuneo
Cuneo, Italy
Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants).
Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants)
Time frame: from surgery up to at least 24 months of follow up after surgery
Perioperative complications
Clavien-Dindo classification
Time frame: from the date of surgery up to six months after surgery
Recurrence site
Time frame: from the date of surgery up to at least 24 months of follow up
2-year progression free survival
Time frame: 24 months after surgery
2-year overall survival
Time frame: 24 months after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.