Clinical trial NCT05564234: Role of Laparoscopy in Assessing Resectability of Ovarian Cancer
Official title: Role of Laparoscopy in Assessing Tumor Resectability in Ovarian Cancer Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-10-03
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of Work is Prevention of unnecessary laparotomies and failed attempts to perform optimal cytoreduction in women with advanced ovarian cancer.

Detailed description: Ovarian cancer is diagnosed at advanced stages in 80% of cases, leading to 5-year survival of approximately 30 %. Tumor reductive surgery and platinum and taxane-based chemotherapy has been the mainstay of treatment for advanced disease . The presence of residual disease after primary debulking surgery is a highly significant prognostic factor in women with advanced ovarian cancer. In up to 60 % of women, residual tumor of \>1 cm is left behind after primary debulking surgery. These women might have benefited from neoadjuvant chemotherapy (NACT) prior to interval debulking surgery instead of primary debulking surgery followed by chemotherapy. Previous studies have demonstrated a clear survival benefit if resection to no gross residual disease (R0 resection) can be achieved, More extensive surgical procedures have been performed to achieve R0 status and have been associated with increased surgical morbidity. Accurate assessment of tumor burden at initial diagnosis using preoperative computed tomography, serum CA 125, and clinical factors has been used in models with variable success and has been difficult to standardize across surgical practices. It is important to determine at the time of diagnosis which patients should undergo primary tumor reductive surgery (TRS), and which should receive neoadjuvant chemotherapy (NACT) in order to minimize surgical morbidity and maximize the extent of cytoreduction. As such, several algorithms to predict the extent of disease encountered at cytoreductive surgery have been developed and evaluated . Fagotti et al. (2008) developed a laparoscopic scoring algorithm comprised of seven parameters: omental caking, peritoneal carcinomatosis, diaphragmatic carcinomatosis, mesenteric retraction, bowel infiltration, stomach infiltration, and liver metastases. . A laparoscopy-based scoring model developed by Fagotti et al.,(2008) demonstrated that a predictive index value score of 8 or greater had a specificity of 100%, positive predictive value of 100%, and negative predictive value of 70% for predicting a suboptimal primary tumor reductive surgery. Optimal tumor reductive surgery was defined as

1 cm or less in this model . Follow-up studies have demonstrated that laparoscopic scoring carries a low risk of complications; helps avoid unnecessary laparotomies in patients in whom cytoreduction to no gross residual disease would not be possible. To provide a more standardized approach to the management of patients with advanced ovarian cancer, this study will be performed to triage appropriate patients to laparoscopic scoring assessment using the previously validated scoring algorithm as reported by Fagotti, We will estimate the effects of the laparoscopic scoring algorithm in patients with advanced ovarian cancer to improve complete gross surgical resection rates and to determine the resulting clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with suspicious ovarian cancer by clinical and radiological assessment are included in this study.

Exclusion Criteria:

* Patients with poor Eastern Cooperative Oncology Group grade more than 2.
* Medical comorbidities at the time of diagnosis precluding primary surgery, newly diagnosed deep venous thrombosis or pulmonary embolus within 6 weeks of presentation.
* Immobile pelvic tumor reaching to xiphisternum leading to conclusions that complete cytoreductive surgery is not feasible
* Intrahepatic metastatic disease of more than one centimetre
* Para-aortic lymphadenopathy larger than one centimetre above the level of the renal veins
* Any contraindication for laparoscopy as cardiopulmonary compromise, intracranial diseases or large ventral hernia.

Primary outcomes:
measure: complete gross resection of tumor
timeFrame: baseline
Secondary outcomes:
measure: Comparison between the accuracy of laparoscopy and CT with contrast on the abdomen
timeFrame: baseline
measure: surgical morbidity.
timeFrame: 1 month
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine, Zagazig Univeristy
state: Sharkia
Study officials:
affiliation: faculty of medicine,zagazig univeristy
name: wael hu elbrombly, MD
role: STUDY_DIRECTOR
affiliation: faculty of medicine,zagazig univeristy
name: hanan at ghaly, MD
role: STUDY_DIRECTOR
affiliation: faculty of medicine,zagazig univeristy
name: mohamed ab lashin, MD
role: STUDY_DIRECTOR
affiliation: faculty of medicine,zagazig univeristy
name: muhannad mo azab, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fagotti A, Ferrandina G, Fanfani F, Ercoli A, Lorusso D, Rossi M, Scambia G. A laparoscopy-based score to predict surgical outcome in patients with advanced ovarian carcinoma: a pilot study. Ann Surg Oncol. 2006 Aug;13(8):1156-61. doi: 10.1245/ASO.2006.08.021. Epub 2006 Jun 21.
citation: Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17.
citation: Fleming ND, Nick AM, Coleman RL, Westin SN, Ramirez PT, Soliman PT, Fellman B, Meyer LA, Schmeler KM, Lu KH, Sood AK. Laparoscopic Surgical Algorithm to Triage the Timing of Tumor Reductive Surgery in Advanced Ovarian Cancer. Obstet Gynecol. 2018 Sep;132(3):545-554. doi: 10.1097/AOG.0000000000002796.