Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis (CARPEMAN)
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ClinicalTrials.gov Identifier: NCT02493972 |
Recruitment Status :
Completed
First Posted : July 10, 2015
Last Update Posted : July 9, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer With Peritoneal Carcinosis | Procedure: GelPort Procedure: laparotomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Actual Study Start Date : | September 2015 |
Actual Primary Completion Date : | July 2019 |
Actual Study Completion Date : | July 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: manual exploration by GelPort
manual exploration in supplement of coelioscopy before laparotomy
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Procedure: GelPort
Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability Procedure: laparotomy laparotomy will be performed if indication confirmed by manual exploration |
- 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 ]
- Number of patients with complications (eventrations, infections, pains) after manual exploration [ Time Frame: 1 month after inclusion ]
- Number of patients with parietal metastases [ Time Frame: 1 month after inclusion ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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): NCT02493972
France | |
CHU | |
Amiens, France | |
Centre Françis Baclesse | |
Caen, France | |
CHU | |
Caen, France | |
Institut de Cancérologie de l'Ouest | |
Nantes, France | |
Centre Henri Becquerel | |
Rouen, France |
Responsible Party: | Centre Francois Baclesse |
ClinicalTrials.gov Identifier: | NCT02493972 |
Other Study ID Numbers: |
2015-A00615-44 |
First Posted: | July 10, 2015 Key Record Dates |
Last Update Posted: | July 9, 2019 |
Last Verified: | July 2019 |
ovarian cancer peritoneal carcinosis manual exploration surgery GelPort |
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |