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Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis (CARPEMAN)

Primary Purpose

Ovarian Cancer With Peritoneal Carcinosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
GelPort
laparotomy
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer With Peritoneal Carcinosis focused on measuring ovarian cancer, peritoneal carcinosis, manual exploration, surgery, GelPort

Eligibility Criteria

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

Inclusion Criteria:

  • Over 18 years of age Patient
  • Woman presenting a peritoneal carcinosis presumed ovarian origin
  • Coelioscopy (1st intent or recurrence) planned or performed in the last 4 weeks for laparotomy. The peritoneal cancer index of Sugarbaker must be available.
  • WHO 0 - 2
  • Membership in a social security system
  • Patient having given her written consent

Exclusion Criteria:

  • Male
  • Contraindication in the coelioscopy
  • Any associated medical or psychological condition which could compromise the capacity of the patient to participate in the study
  • Patient deprived of freedom, under guardianship or guardianship

Sites / Locations

  • CHU
  • Centre Françis Baclesse
  • CHU
  • Institut de Cancérologie de l'Ouest
  • Centre Henri Becquerel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

manual exploration by GelPort

Arm Description

manual exploration in supplement of coelioscopy before laparotomy

Outcomes

Primary Outcome Measures

evaluate the number of patients with or without laparotomy after evaluation of the resectability by coelioscopy and coelioscopy more manual exploration

Secondary Outcome Measures

Number of patients with complications (eventrations, infections, pains) after manual exploration
Number of patients with parietal metastases

Full Information

First Posted
June 26, 2015
Last Updated
July 8, 2019
Sponsor
Centre Francois Baclesse
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT02493972
Brief Title
Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis
Acronym
CARPEMAN
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
Groupement Interrégional de Recherche Clinique et d'Innovation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Multicenter prospective diagnostic study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer With Peritoneal Carcinosis
Keywords
ovarian cancer, peritoneal carcinosis, manual exploration, surgery, GelPort

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
manual exploration by GelPort
Arm Type
Experimental
Arm Description
manual exploration in supplement of coelioscopy before laparotomy
Intervention Type
Procedure
Intervention Name(s)
GelPort
Intervention Description
Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability
Intervention Type
Procedure
Intervention Name(s)
laparotomy
Intervention Description
laparotomy will be performed if indication confirmed by manual exploration
Primary Outcome Measure Information:
Title
evaluate the number of patients with or without laparotomy after evaluation of the resectability by coelioscopy and coelioscopy more manual exploration
Time Frame
1 month after inclusion
Secondary Outcome Measure Information:
Title
Number of patients with complications (eventrations, infections, pains) after manual exploration
Time Frame
1 month after inclusion
Title
Number of patients with parietal metastases
Time Frame
1 month after inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years of age Patient Woman presenting a peritoneal carcinosis presumed ovarian origin Coelioscopy (1st intent or recurrence) planned or performed in the last 4 weeks for laparotomy. The peritoneal cancer index of Sugarbaker must be available. WHO 0 - 2 Membership in a social security system Patient having given her written consent Exclusion Criteria: Male Contraindication in the coelioscopy Any associated medical or psychological condition which could compromise the capacity of the patient to participate in the study Patient deprived of freedom, under guardianship or guardianship
Facility Information:
Facility Name
CHU
City
Amiens
Country
France
Facility Name
Centre Françis Baclesse
City
Caen
Country
France
Facility Name
CHU
City
Caen
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Nantes
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France

12. IPD Sharing Statement

Learn more about this trial

Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis

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