Peritoneal Carcinomatosis Extent Evaluation: Radiologic, Laparoscopic and Pathologic.

Peritoneal Carcinomatosis Clinical Trial

Official title:

Imaging Evaluation of Peritoneal Carcinomatosis Extent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03798132
• Other study ID #: SouthECI
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: South Egypt Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

pathologically proved ovarian cancer patients that underwent contrast enhanced abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be included in the study. Calculation of PCI (peritoneal cancer index) using Sugarbaker's method, peritoneal carcinomatosis extent will be categorized into low, moderate and large. Agreement in general and in each category between CT, laparoscopy, surgery and pathology will be assessed using kappa agreement.

Description:

we will search medical records of primary ovarian cancer patients underwent CT abdomen, laparoscopy followed by cytoreductive surgery to calculate peritoneal carcinomatosis extent by each modality.

Regional PCI was calculated in each of the 13 anatomical abdominopelvic regions, then total PCI by summation of the lesion size score, it ranged from 0 to 39. Categorization of peritoneal carcinomatosis was classified into 3 categories low if PCI < 10, moderate if 10-20, and large if >20.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2020
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:pathologically proved ovarian cancer patients underwent contrast enhanced abdominopelvic CT and diagnostic laparoscopy before cytoreductive surgery -

Exclusion Criteria:recurrent ovarian cancer

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis

Intervention

Diagnostic Test:
• laparoscopy
evaluation of peritoneal carcinomatosis by laparoscopy

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Shimaa Abdalla Ahmed

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peritoneal carcinomatosis	Agreement in general and in each category between CT, laparoscopy, surgery and pathology was assessed using kappa agreement.	one year
Secondary	surgical decision making.	correlation of peritoneal carcinomatosis categorization with surgical decision	one year