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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02829788
Acronym
COELIOCHIP
Enrollment
50
Registered
2016-07-12
Start date
2015-11-30
Completion date
2017-12-31
Last updated
2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Peritoneal Carcinomatosis

Keywords

Digestive peritoneal carcinomatosis, laparoscopy, laparotomy, peritoneal cancer index (PCI), staging

Brief summary

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.

Interventions

OTHERNon interventional

Peroperative data collection

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Peritoneal carcinomatosis stagingduring laparoscopy and during laparotomy (Day 1)To score the Collect detailed detailed Peritoneal Cancer Index (PCI) by laparoscopy following the laparotomy procedure in order to evaluate the accuracy and adequacy of laparoscopic surgical staging comparing to laparotomic approach.

Countries

France

Contacts

Primary ContactOlivier GLEHEN, Prof
olivier.glehen@chu-lyon.fr(0)4 78 862 371
Backup ContactPeggy JOURDAN-ENFER
peggy.jourdan-enfer@chu-lyon.fr(0)4 78 864 534

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026