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

NCT02829788 | Unknown

• 1 other identifier: 69HCL16_0433
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Peritoneal Carcinomatosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Peritoneal carcinomatosis staging

  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.

  during laparoscopy and during laparotomy (Day 1)

Study Arms (1)

Digestive peritoneal carcinomatosis staging

All patients underwent laparoscopic followed by laparotomic surgical staging.

Other: Non interventional

Interventions

Non interventional OTHER

Peroperative data collection

Digestive peritoneal carcinomatosis staging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospectively diagnosed patients initially treated with surgery and adjuvant chemotherapy who have a high risk of developing colorectal peritoneal carcinomatosis. All patients will receive the current standard adjuvant treatment: 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence.

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Pierre-Bénite, 69495, France

RECRUITING

Study Officials

• Olivier GLEHEN, Prof

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier GLEHEN, Prof

CONTACT

(0)4 78 862 371; olivier.glehen@chu-lyon.fr

Peggy JOURDAN-ENFER

CONTACT

(0)4 78 864 534; peggy.jourdan-enfer@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 12, 2016
• Study Start: November 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

FR (1)