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PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors
Sponsor: Ospedale Santa Croce-Carle Cuneo
Summary
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
Official title: Pelvic peritOnectomy iN Early Stage Ovarian Tumors: a prospEctive Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
390
Start Date
2026-02
Completion Date
2032-08
Last Updated
2025-12-09
Healthy Volunteers
No
Interventions
systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach
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.
Histopathologic Analysis
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
Locations (1)
Azienda Ospedaliera Santa Croce e Carle Cuneo
Cuneo, Italy