Minimally Invasive Simultaneous Colorectal and Liver Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03551470|
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
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.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Procedure: Robotic one-stage colorectal and liver resection|
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
|Study Type :||Observational|
|Estimated Enrollment :||22 participants|
|Official Title:||Robot-assisted Resection of Colorectal Cancer and Synchronous Liver Metastases:Preliminary Experience, Technique and Literature Review|
|Actual Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||October 2020|
Synchronous colorectal cancer and liver metastases
Robotic (Da Vinci) one-stage colorectal and liver resection
Procedure: Robotic one-stage colorectal and liver resection
- Short-term perioperative surgical outcomes [ Time Frame: intra-operative - within 30 post-operative day ]Morbidity
- Mortality [ Time Frame: Intra-operative -within 30 post-operative day ]
- Blood loss [ Time Frame: Intra-operative ]Measured in mL
- Conversion rate [ Time Frame: Intra-operative ]
- Operative time [ Time Frame: Intra-operative ]Measured in minutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551470
|Michele De Rosa||Recruiting|
|Foligno, Perugia, Italy, 06034|
|Contact: Michele De Rosa +393397871350 firstname.lastname@example.org|