Minimally Invasive Simultaneous Colorectal and Liver Surgery

Colorectal Cancer Clinical Trial

Official title:

Robot-assisted Resection of Colorectal Cancer and Synchronous Liver Metastases:Preliminary Experience, Technique and Literature Review

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03551470
• Other study ID #: AOSGB1
• Status: Recruiting
• Start date: October 2012
• Est. completion date: October 2020

Study information

• Verified date: June 2018
• Source: Azienda Ospedaliera San Giovanni Battista
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: October 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Robotic one-stage colorectal and liver resection

Locations

Country	Name	City	State
Italy	Michele De Rosa	Foligno	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Giovanni Battista

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term perioperative surgical outcomes	Morbidity	intra-operative - within 30 post-operative day
Primary	Mortality		Intra-operative -within 30 post-operative day
Primary	Blood loss	Measured in mL	Intra-operative
Primary	Conversion rate		Intra-operative
Primary	Operative time	Measured in minutes	Intra-operative