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NCT03235648 Clinical Trial

Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:
Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03235648
Other study ID # R/17.05.162
Secondary ID
Status Recruiting
Phase N/A
First received July 2, 2017
Last updated July 30, 2017
Start date June 1, 2017
Est. completion date June 1, 2023

Study information
Verified date July 2017
Source Mansoura University
Contact Basel R. Abdelfattah, MD, MRCS
Phone 01001974340
Email dr.basel@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced ovarian cancer

Description:

The role of cardiophrenic lymph node assessment and excision in advanced ovarian cancer is still debatable , correlation of radiological finding with pathological findings after reaction of radiological positive lymph nodes and its impact in diseases free survival and over all survival

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date June 1, 2023
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 80 Years
Eligibility Inclusion criteria

- Ovarian cancer patient (FIGO stage III-IV)

- Preoperative CT showing CPLN with short axis diameter > 5mm.

- Anathestically fit patient (ASA score I or II).

- Accepted pulmonary function test.

- Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled

- Written informed consent.

- Achievement of optimal cytoreduction intra-abdominal( No residual disease more than 1 cm )

Exclusion Criteria:

- Anathestically unfit patient

- Unresectable disease

- Patient refusal

- No detected CPLN by preoperative radiology

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• cardiophrenic lymph nodes resection
surgical resection

Locations
Country Name City State
Egypt Oncology center, Mansoura University Cairo Dakhlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Other Overall survival 2 years survivals of the patients up to 2 years following the end of study
Primary number of CPN retrieved/pathological nodes correlation of radiological active lymph nodes with pathological findings up to 3 years
Secondary Progression free survival 2 years progression without disease recurrence up to 2 years following the end of study
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