The Preoperative Predictors of Optimal Cytoreductive Surgery in Women With Advanced Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

The Preoperative Predictors of Optimal Cytoreductive Surgery in Women With Advanced Epithelial Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856841
• Other study ID #: 152
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 2, 2016
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial Summary

44 patients were enrolled in this study as they had malignant epithelial ovarian tumor.Pre-operative staging was assessed by CT scan based on FIGO classification and compared to the standard laparotomy surgical staging. Maximal surgical effort for Optimum cytoreduction was achieved and the risk factors for sub-optimal cytoreduction were studied

Description:

Each patient was subjected to comprehensive medical history taking and careful clinical examination, laboratory investigations (CA-125) and imaging (abdomino-pelvic CT scan). Patients with suspected bowel involvement were subjected for colonoscopy.

Pre-operative Abdomino-pelvic CT scans:

Preoperative CT scans were performed with a high-speed scanner after the oral and intravenous administration of contrast medium. The hard copy images were reviewed by consultant radiologists for assessment of the findings suggestive of malignant adnexal mass which are bilateral lesions, thick septa, enhancing solid components, ascites, and peritoneal deposits .

Pre-operative staging of cancer ovary was assessed by CT scan based on FIGO classification:

1. Stage II: tumor involving ovaries with pelvic extension +/- ascites.

2. Stage III: tumor involving ovaries with peritoneal implant outside pelvis +/- ascites.

3. Stage IV: tumor involving ovaries with parenchymal liver metastasis and/or pleural effusion.

Surgical treatment:

All patients underwent standard longitudinal laparotomy, intensive surgical staging and maximal surgical effort for Optimum cytoreduction which was included all of the following (total abdominal hysterectomy, bilateral salpingo-oophorectomy, infracolic-omentectomy, appendectomy, surgical removal of all tumor masses, intestinal resections if required).Achievement of no gross residual disease has been attempted in all cases. Finally, patients were divided into two groups:

• Suboptimal cytoreduction group with any gross tumor residue.

• Optimal cytoreduction group without any gross tumor residue.

Surgical risk factors for optimum cytoreduction:

• Parenchymal liver involvement.

• Omental involvement.

• Bowel involvement.

• Para aortic lymph node involvement.

• Peritoneal carcinomatosis: it is defined as disease > 4 mm involving 2 or more of the following areas; lateral colic gutters, anterior abdominal wall, diaphragm, and pelvic peritoneal reflections.

• Pelvic sidewall invasion: it is defined as presence of one or more of the following; tumor fixed to the pelvic bony wall, encasement of iliac vessels, and hydroureter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• malignant epithelial ovarian tumor (EOC)

FIGO stage II, III, and IV.

Exclusion Criteria:

• Patients with previous abdominal or pelvic major surgery, synchronous abdominal or pelvic pathology or medically unfit for surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of optimum cytoreduction	ability to remove all gross lesions from the tumor intraoperatively and leaving no ovarian lesion seen by naked eye of the expert surgeon	1 year after surgery	Yes