Study Comparing the Role of the Laparoscopy Surgical Staging in the Peritoneal Carcinomatosis to Laparotomic Approach

NCT ID: NCT02829788

Last Updated: 2016-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-12-31

Brief Summary

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The peritoneum is the second most common site of recurrence in patients with colorectal cancer. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy improve the prognosis of these patients and incorporates surgical removal of all visible disease followed by chemical destruction of microscopic disease through chemoperfusion. The most validated predictors of outcome are preoperative tumor burden measured in terms of the peritoneal carcinomatosis index (PCI) and completeness of cytoreduction (CC score). Diagnostic laparoscopy prior to resection is widely used in hepatopancreaticobiliary and colorectal cancer and has been shown to be effective in excluding unnecessary laparotomy associated with higher morbidity.

Detailed Description

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Conditions

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Colorectal Peritoneal Carcinomatosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Digestive peritoneal carcinomatosis staging

All patients underwent laparoscopic followed by laparotomic surgical staging.

Non interventional

Intervention Type OTHER

Peroperative data collection

Interventions

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Non interventional

Peroperative data collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with Colorectal cancer with a resected minimal synchronous peritoneal carcinomatosis, or ovarian metastases, tumour rupture in the abdominal cavity.
* Patients received six months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified)

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier GLEHEN, Prof

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet, PIERRE-BENITE, FRANCE, 69495

Locations

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Hospices Civils de Lyon - Centre Hospitalier Lyon Sud Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet

Pierre-Bénite, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier GLEHEN, Prof

Role: CONTACT

(0)4 78 862 371 ext. +33

Peggy JOURDAN-ENFER

Role: CONTACT

(0)4 78 864 534 ext. +33

Facility Contacts

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Olivier GLEHEN, Prof

Role: primary

(0)4 78 862 371 ext. +33

Peggy JOURDAN-ENFER

Role: backup

(0)4 78 864 534 ext. +33

Other Identifiers

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69HCL16_0433

Identifier Type: -

Identifier Source: org_study_id

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