Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:36 PM
Study NCT ID:
NCT07416435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concordance Between Radiologic Laparoscopic and Laparotomic Evaluation for Complete Cytoreduction of Ovarian Masses
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Concordance Between Radiologic Laparoscopic and Laparotomic Evaluation for Complete Cytoreduction of Ovarian Masses
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ovarian mass occur in women of all ages, and their etiology and frequency range age accordingly. The ovarian mass may come from functional or physiological changes, inflammatory processes, endometriosis, benign and malignant tumor(1).
Ovarian cancer (OC), the most lethal gynecological malignancy, usually presents in advanced stages. Characterized by peritoneal and lymphatic dissemination, OC necessitates a complex surgical approach usually involving the upper abdomen with the aim of achieving optimal cytoreduction without visible macroscopic disease (R0)(2).
The presence of a residual tumor at the end of surgery is indeed recognized as the main negative prognostic factor for patients with AOC. In this context, complete cytoreductive surgery (R0) achieving no gross residual disease is associated with the best survival outcomes(3).
Despite the increasing adoption of diagnostic laparoscopy, laparotomic assessment during definitive cytoreductive surgery remains the gold standard for evaluating the true extent of disease and determining resectability(4).
Over the years, different score systems have been proposed and evaluated, aiming to assess the peritoneal spread of the disease and predict whether it is possible to obtain R0. Several imaging-based scoring models, using computed tomography (CT), have been suggested to predict the outcomes of PDS. These models included different radiological criteria, such as peritoneal thickening, ascites, para-aortic lymphadenopathy, and bowel involvement. Although the overall good predictive performance, the main limitation is represented by the unsuccessful rate when cross-validations datasets were used(3).
Staging laparoscopy has shown to be a minimally invasive tool able to properly drive the therapeutic choice between primary cytoreductive surgery and neoadjuvant chemotherapy. To quickly select candidates for upfront surgery, and to decrease the delay to cytoreductive surgery or neoadjuvant chemotherapy, we offer patients a two-step surgical management protocol in which diagnostic laparoscopy is performed a few weeks prior to cytoreductive surgery(5).
a laparoscopic scoring algorithm (predictive index, (PI) which developed by Fagotti et al.2015 including seven parameters based on intra-abdominal distribution of the disease. Although the accuracy of the laparoscopic model is 75% at predicting surgical outcome, the percentage of unnecessary laparotomies remains 33%, even after the inclusion of upper abdominal surgical score. Moreover, concordance between PI scores and PDS varies by anatomical location, with the lowest concordance in predicting bowel infiltration(6).
Ovarian cancer (OC), the most lethal gynecological malignancy, usually presents in advanced stages. Characterized by peritoneal and lymphatic dissemination, OC necessitates a complex surgical approach usually involving the upper abdomen with the aim of achieving optimal cytoreduction without visible macroscopic disease (R0)(2).
The presence of a residual tumor at the end of surgery is indeed recognized as the main negative prognostic factor for patients with AOC. In this context, complete cytoreductive surgery (R0) achieving no gross residual disease is associated with the best survival outcomes(3).
Despite the increasing adoption of diagnostic laparoscopy, laparotomic assessment during definitive cytoreductive surgery remains the gold standard for evaluating the true extent of disease and determining resectability(4).
Over the years, different score systems have been proposed and evaluated, aiming to assess the peritoneal spread of the disease and predict whether it is possible to obtain R0. Several imaging-based scoring models, using computed tomography (CT), have been suggested to predict the outcomes of PDS. These models included different radiological criteria, such as peritoneal thickening, ascites, para-aortic lymphadenopathy, and bowel involvement. Although the overall good predictive performance, the main limitation is represented by the unsuccessful rate when cross-validations datasets were used(3).
Staging laparoscopy has shown to be a minimally invasive tool able to properly drive the therapeutic choice between primary cytoreductive surgery and neoadjuvant chemotherapy. To quickly select candidates for upfront surgery, and to decrease the delay to cytoreductive surgery or neoadjuvant chemotherapy, we offer patients a two-step surgical management protocol in which diagnostic laparoscopy is performed a few weeks prior to cytoreductive surgery(5).
a laparoscopic scoring algorithm (predictive index, (PI) which developed by Fagotti et al.2015 including seven parameters based on intra-abdominal distribution of the disease. Although the accuracy of the laparoscopic model is 75% at predicting surgical outcome, the percentage of unnecessary laparotomies remains 33%, even after the inclusion of upper abdominal surgical score. Moreover, concordance between PI scores and PDS varies by anatomical location, with the lowest concordance in predicting bowel infiltration(6).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: