Research
Oncology
A multicentric trial (Olympia–MITO 13) on the accuracy of laparoscopy to assess peritoneal spread in ovarian cancer

Presented in oral format at the 20th Annual World Congress of Gynecology and Obstetrics of the International Federation of Gynecology and Obstetrics (FIGO), Rome, Italy, Oct. 7-12, 2012.
https://doi.org/10.1016/j.ajog.2013.07.016Get rights and content

Objective

The objective of the study was to prospectively evaluate the accuracy of laparoscopy performed in satellite centers (SCs) to describe intraabdominal diffusion of advanced ovarian cancer (AOC).

Study Design

Patients with a clinical/radiological suspicion of AOC were included in the protocol. SCs were selected among those surgeons, spending a short intensive training period at the coordinator center (CC) to learn the application of staging laparoscopy (S-LPS) in AOC. All women underwent S-LPS at the SCs, and the surgical procedure was recorded and blindly reviewed at the CC. Calculating specificity, positive and negative predictive values, and the accuracy for each parameter with respect to the CC assessed the diagnostic performance of S-LPS. The Cohen's kappa was used to test the interobserver agreement of each parameter.

Results

One hundred sixty-eight cases were considered eligible for the study. A per-protocol analysis was performed on 120 cases. The worst laparoscopic assessable feature was mesenteric retraction, whereas the remaining variables ranged from 99.2% (peritoneal carcinomatosis) to 90% (bowel infiltration). All but 1 SC (SC number 4) reached an accuracy rate of 80% or greater for both single parameters and overall score. The Cohen's kappa and the P value for overall predicitive index value were 0.685 and .01, respectively, but improved to 0.773 and .388 after removing the SC number 4 from the analysis.

Conclusion

S-LPS allows an accurate and reliable assessment of intraperitoneal diffusion of disease in AOC patients in trained gynecological oncology centers.

Section snippets

Study design

Olympia-MITO 13 is a prospective multicentric trial registered (ClinicalTrials.gov, no. NCT01595204). Each center obtained the approval of the local ethical committee before enrolling patients. The design of the study is shown in Figure 1.

Women with first clinical and/or radiological diagnosis of advanced ovarian/fallopian tube or primary peritoneal cancer (International Federation of Gynecology and Obstetrics stages III-IV) were consecutively evaluated by a gynecologic oncologist who proposed

Results

From March 2010 to March 2012, 24 SCs agreed to participate to the prospective multicentric trial Olympia-MITO 13 (protocol identification NCT01595204). Seventeen (70.8%) did actually enroll patients. One hundred sixty-eight cases with suspicious primary advanced ovarian/peritoneal cancer were considered eligible for the study. Three women (1.8%) refused S-LPS and were then excluded. The remaining patients were submitted to S-LPS at the SCs, and no intraoperative complications were registered.

Comment

In the light of some recent advances in ovarian cancer treatment,19, 20, 21 the correct timing to perform debulking surgery is a crucial point in the natural history of the disease.

In this context, the availability of a minimally invasive approach, such as S-LPS, able to directly visualize intraperitoneal cavity as the preferred site of ovarian cancer diffusion, is a great diagnostic opportunity for the surgeon to draw a more individualized management of AOC. However, the introduction of a

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    The authors report no conflict of interest.

    Cite this article as: Fagotti A, Vizzielli G, De Iaco P, et al. A multicentric trial (Olympia–MITO 13) on the accuracy of laparoscopy to assess peritoneal spread in ovarian cancer. Am J Obstet Gynecol 2013;209:462.e1-11.

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