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

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ClinicalTrials.gov Identifier: NCT03235648
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Basel Refky, MD, Mansoura University

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: cardiophrenic lymph nodes resection Not Applicable

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: cardiophrenic nodes excision in ovarian cancer
We are going to evaluate the comorbidites and impact of cardiophrenic lymph nodes excision in cases of advanced ovarian cancer with positive cardiophrenic lymph nodes
Procedure: cardiophrenic lymph nodes resection
surgical resection




Primary Outcome Measures :
  1. number of CPN retrieved/pathological nodes [ Time Frame: up to 3 years ]
    correlation of radiological active lymph nodes with pathological findings


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: up to 2 years following the end of study ]
    2 years progression without disease recurrence


Other Outcome Measures:
  1. Overall survival [ Time Frame: up to 2 years following the end of study ]
    2 years survivals of the patients



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235648


Contacts
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Contact: Basel R. Abdelfattah, MD, MRCS 01001974340 ext +2 dr.basel@hotmail.com

Locations
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Egypt
Oncology center, Mansoura University Recruiting
Cairo, Dakhlia, Egypt, 35116
Contact: Basel R. Abdelfattah, MD,MRCS    01001974340 ext +2    dr.basel@hotmail.com   
Sponsors and Collaborators
Mansoura University

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Responsible Party: Basel Refky, MD, Doctor, Mansoura University
ClinicalTrials.gov Identifier: NCT03235648     History of Changes
Other Study ID Numbers: R/17.05.162
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma