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

Colorectal Peritoneal Carcinomatosis Clinical Trial

— COELIOCHIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02829788
• Other study ID #: 69HCL16_0433
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2016
• Last updated: July 11, 2016
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: Olivier GLEHEN, Prof
• Phone: (0)4 78 862 371
• Email: olivier.glehen[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Peritoneal Carcinomatosis

Intervention

Other:
• Non interventional
Peroperative data collection

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Centre Hospitalier Lyon Sud Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet	Pierre-benite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No