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Role of Laparoscopy in Assessing Resectability of Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopy then primary cytoreductive surgery
laparoscopy then neoadjuvant chemotherapy followed by interval cytoreductive surgery
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine, Zagazig Univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Neoadjuvant chemotherapy

primary cytoreductive surgery

Arm Description

cases with predictive index value score 8 or greater in which primary cytoreductive surgery was not feasible were were referred for neoadjuvant chemotherapy then interval cytoreductive surgery was done

cases with predictive index value score less than 8 were offered primary cytoreductive surgery.

Outcomes

Primary Outcome Measures

complete gross resection of tumor
The primary outcome for our study included improving complete gross resection rates at tumour cytoreductive surgery compared to historical data and avoids futile laparotomy defined as residual tumour with a maximum diameter more than 1 cm after primary cytoreductive surgery.

Secondary Outcome Measures

Comparison between the accuracy of laparoscopy and CT with contrast on the abdomen
The secondary outcomes included comparison between laparoscopic assessment and preoperative CT with contrast according to the accuracy of detection of Omental lesion. Peritoneal nodules. Implantations on the surface of diaphragm. Affection and retraction of the mesentry of bowel. Intestinal infiltration. Stomach implants. Metastasis on hepatic or splenic surfaces.
surgical morbidity.
any complication during surgery or postoperative morbidity

Full Information

First Posted
September 26, 2022
Last Updated
October 1, 2022
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05564234
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
April 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant chemotherapy
Arm Type
Active Comparator
Arm Description
cases with predictive index value score 8 or greater in which primary cytoreductive surgery was not feasible were were referred for neoadjuvant chemotherapy then interval cytoreductive surgery was done
Arm Title
primary cytoreductive surgery
Arm Type
Active Comparator
Arm Description
cases with predictive index value score less than 8 were offered primary cytoreductive surgery.
Intervention Type
Procedure
Intervention Name(s)
laparoscopy then primary cytoreductive surgery
Intervention Description
Laparoscopy was used to calcautation of fagotti PIV score , if less than 8 primary cytoreductive surgery were done.
Intervention Type
Procedure
Intervention Name(s)
laparoscopy then neoadjuvant chemotherapy followed by interval cytoreductive surgery
Intervention Description
Laparoscopy was used to calcautation of fagotti PIV score and provides the histological diagnosis , if score more than 8 the patient were received neoadjuvant chemotherapy followed by interval cytoreductive surgery
Primary Outcome Measure Information:
Title
complete gross resection of tumor
Description
The primary outcome for our study included improving complete gross resection rates at tumour cytoreductive surgery compared to historical data and avoids futile laparotomy defined as residual tumour with a maximum diameter more than 1 cm after primary cytoreductive surgery.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Comparison between the accuracy of laparoscopy and CT with contrast on the abdomen
Description
The secondary outcomes included comparison between laparoscopic assessment and preoperative CT with contrast according to the accuracy of detection of Omental lesion. Peritoneal nodules. Implantations on the surface of diaphragm. Affection and retraction of the mesentry of bowel. Intestinal infiltration. Stomach implants. Metastasis on hepatic or splenic surfaces.
Time Frame
baseline
Title
surgical morbidity.
Description
any complication during surgery or postoperative morbidity
Time Frame
1 month

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wael hu elbrombly, MD
Organizational Affiliation
faculty of medicine,zagazig univeristy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
hanan at ghaly, MD
Organizational Affiliation
faculty of medicine,zagazig univeristy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mohamed ab lashin, MD
Organizational Affiliation
faculty of medicine,zagazig univeristy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
muhannad mo azab, Msc
Organizational Affiliation
faculty of medicine,zagazig univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Zagazig Univeristy
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44511
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
16791447
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.
Results Reference
background
PubMed Identifier
18801470
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.
Results Reference
background
PubMed Identifier
30095787
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.
Results Reference
background

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Role of Laparoscopy in Assessing Resectability of Ovarian Cancer

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