Minimally Invasive Simultaneous Colorectal and Liver Surgery

NCT ID: NCT03551470

Last Updated: 2018-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2020-10-31

Brief Summary

Up to 25% of newly diagnosed patients with colorectal cancer (CRC) have liver metastases (LM). Simultaneous colorectal and hepatic resection has been proven to be a safe and effective approach in dealing with metastatic colorectal cancer.

The aim of this paper is to analyse perioperative and oncological outcomes of minimally invasive (laparoscopic and robotic) one-stage simultaneous resection of liver metastases and colorectal tumor in selected patients affected by colorectal cancer and synchronous liver metastases.

Detailed Description

From October 2012 to March 2018 a minimally invasive one-stage resection was offered to selected patients referred to the investigator's institution with a diagnosis of CRC and synchronous LM, irrespective of the size and location of the primary and metastatic disease. When feasible, a fully-robotic colorectal and liver resection was performed. Prior consent was obtained and full treatment options where submitted to all patients treated. Data collected were prospectively analyzed.

Diagnosis and pre-operative staging were achieved with pancolonoscopy with biopsies and, where contraindicated or not feasible, with CT colonography.

Pelvic MRI with rectal cancer protocol was used for local staging of rectal cancer and total-body contrast-enhanced computed tomography (CT) and liver contrast-enhanced magnetic resonance imaging (MRI) for investigation of metastases. In selected cases a CEUS (contrast-enhanced ultrasound) or liver biopsy was performed in order to achieve a diagnostic definition.

All cases were discussed at multidisciplinary team meeting. Criteria for neoadjuvant chemotherapy were liver unresectability with a potential incomplete liver resection with anticipated positive surgical margins and an insufficient liver remnant.

Absolute contraindications for minimally invasive simultaneous surgery were considered unfitness for surgery due to comorbidities not allowing long operative time, the number of lesions in parenchymal sparing surgery (generally >5), the pre-operative prediction of vascular resection.

Relative contraindications were considered the need for major hepatectomy and the finding of new intraoperative lesions, with consequent potential longer operative time.

Demographic, histopathological, surgical morbidity/mortality and short term peri-operative clinical outcome in all patients undergone simultaneous colorectal and liver resections were prospectively evaluated.

Morbidity evaluation included all intra-operative and early post-operative (within 30 days) complications and rated according to Clavien-Dindo classification.

All data are expressed as mean values ± range when appropriate

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Synchronous colorectal cancer and liver metastases

Robotic (Da Vinci) one-stage colorectal and liver resection

Robotic one-stage colorectal and liver resection

Intervention Type: PROCEDURE

Interventions

Robotic one-stage colorectal and liver resection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• colorectal primary tumor with synchronous liver metastases
• eligibility for minimally-invasive surgery

Exclusion Criteria

• unfitness for prolonged operative time
• liver lesions >5
• pre-operative prediction of vascular resection

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera San Giovanni Battista

OTHER

Sponsor Role: lead

Responsible Party

Michele De Rosa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Michele De Rosa

Foligno, Perugia, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Michele De Rosa

Role: primary

michele.derosa@nhs.net

+393397871350

Other Identifiers

AOSGB1

Identifier Type: -

Identifier Source: org_study_id