Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 41 of 982 for:    colon cancer AND resection

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
Sponsor:
Information provided by (Responsible Party):
Michele De Rosa, Azienda Ospedaliera San Giovanni Battista

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.


Condition or disease Intervention/treatment
Colorectal Cancer Procedure: Robotic one-stage colorectal and liver resection

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


Layout table for study information
Study Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Synchronous colorectal cancer and liver metastases
Robotic (Da Vinci) one-stage colorectal and liver resection
Procedure: Robotic one-stage colorectal and liver resection



Primary Outcome Measures :
  1. Short-term perioperative surgical outcomes [ Time Frame: intra-operative - within 30 post-operative day ]
    Morbidity

  2. Mortality [ Time Frame: Intra-operative -within 30 post-operative day ]
  3. Blood loss [ Time Frame: Intra-operative ]
    Measured in mL

  4. Conversion rate [ Time Frame: Intra-operative ]
  5. Operative time [ Time Frame: Intra-operative ]
    Measured in minutes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Selected patients affected by colorectal cancer with synchronous liver metastases
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Italy
Michele De Rosa Recruiting
Foligno, Perugia, Italy, 06034
Contact: Michele De Rosa    +393397871350    michele.derosa@nhs.net   
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista

Layout table for additonal information
Responsible Party: Michele De Rosa, Principal Investigator, Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier: NCT03551470     History of Changes
Other Study ID Numbers: AOSGB1
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Michele De Rosa, Azienda Ospedaliera San Giovanni Battista:
robotic
laparoscopy
liver surgery
colorectal and synchronous liver metastases
simultaneous surgery

Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Liver Extracts
Hematinics