PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors

Ospedale Santa Croce-Carle Cuneo

Status: Not yet enrolling

Conditions: Peritoneal Carcinosis; Early Stage Ovarian Tumors

Treatments: Diagnostic Test: Histopathologic Analysis; Procedure: systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach

Study type: Interventional

Funder types: Other

Identifiers

NCT07271914

CnGin20251

Details and patient eligibility

About

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

Full description

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

Enrollment: 390 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• FIGO 2018 stage IA-IB epithelial or non-epithelial ovarian or fallopian tube tumors
• Complete preoperative work-up (ultrasound, CT scan, tumor markers)
• Laparoscopic, robotic or open surgical approach
• Signed informed consent

Exclusion criteria

• Sarcomas, melanomas, mesotheliomas, hematologic malignancies
• Advanced ovarian tumors
• Fertility-sparing surgery with uterine preservation
• Inability to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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390 participants in 1 patient group

Enrolled patients with FIGO 2018 IA-IB epithelial or non-epithelial ovarian/fallopian tube neoplasma

Other group

Description:

All patients will receive standard pre-, intra-, and postoperative care according to institutional guidelines. The peritonectomy procedure will not alter the choice of surgical access. Pelvic peritonectomy specimens will be analyzed as part of the final pathology report.

Treatment:

Procedure: systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach

Diagnostic Test: Histopathologic Analysis