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

Ovarian Cancer With Peritoneal Carcinosis Clinical Trial

— CARPEMAN  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493972
• Other study ID #: 2015-A00615-44
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Multicenter prospective diagnostic study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer With Peritoneal Carcinosis
• Ovarian Neoplasms

Intervention

Procedure:
• GelPort
Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability
• laparotomy
laparotomy will be performed if indication confirmed by manual exploration

Locations

Country	Name	City	State
France	CHU	Amiens
France	Centre Françis Baclesse	Caen
France	CHU	Caen
France	Institut de Cancérologie de l'Ouest	Nantes
France	Centre Henri Becquerel	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Groupement Interrégional de Recherche Clinique et d'Innovation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the number of patients with or without laparotomy after evaluation of the resectability by coelioscopy and coelioscopy more manual exploration		1 month after inclusion
Secondary	Number of patients with complications (eventrations, infections, pains) after manual exploration		1 month after inclusion
Secondary	Number of patients with parietal metastases		1 month after inclusion