Perioperative Outcomes of Simultaneous Colorectal and Liver Resections (SIMULT)

Simultaneous Resection of Colorectal Cancer and Synchronous Liver Metastases: What Determines the Risk of Unfavorable Outcomes? A Retrospective International Multicenter Study

The use of a simultaneous resection in patients with synchronous colorectal liver metastases has increased over the past decades. However, it remains unclear when a simultaneous resection is beneficial and when it should be avoided. The objective of this retrospective study is therefore to compare the outcomes of a simultaneous resection for synchronous colorectal liver metastases in different settings, and to assess which factors are independently associated with unfavorable outcomes.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer Metastatic; Surgical Procedure, Unspecified
• Intervention / Treatment: Procedure: Technically major liver resection; Procedure: Major liver resection

• Study Type: Observational
• Enrollment (Actual): 766

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Brescia, Lombardy, Italy, 25124
      • Fondazione Poliambulanza Istituto Ospedaliero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that underwent an elective minimally invasive or open simultaneous resection of colorectal cancer and synchronous colorectal liver metastases in 17 hepato-biliary referall centers in the time period from January 2004 to December 2019

Description

Inclusion Criteria:

• Elective minimally invasive or open simultaneous resection of colorectal cancer and synchronous colorectal liver metastases

Exclusion Criteria:

• (Partially) robotic-assisted or thoracoscopic procedures
• First stage of associating liver partition and portal vein ligation for staged hepatectomy (ALPPS)
• Patients that underwent major concurrent procedures

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Minor liver resection; Minor liver resection (<3 contiguous segments) in the anterolateral segments
Technically major liver resection; Minor liver resection (<3 contiguous segments) in the posterosuperior segments (Segment 1,4a,7,8)	Procedure: Technically major liver resection; Minor liver resection (<3 contiguous segments) in the posterosuperior segments (segment 1,4a,7,8)
Major liver resection; Major liver resection (3 or more contiguous segments)	Procedure: Major liver resection; Major liver resection (3 or more contiguous segments)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major complications	Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure	30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 resection margin	Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.	30 days postoperatively
Intraoperative blood loss	Intraoperative blood loss in milliliters	During the surgical procedure
Overall complications	Overall complications related to the surgical procedure	30 days postoperatively
Length of hospital stay	The length of hospital stay for the surgical procedure	30 days postoperatively
Operative time	Operative time in minutes	During the surgical procedure
Conversion to open surgery	Intra-operative conversion to an open or hand-assisted procedure in the minimally invasive group	During the surgical procedure
Mortality	Postoperative mortality	90 days postoperatively
Red blood cell transfusion	Intraoperative red blood cell transfusion	During the surgical procedure
Intraoperative incidents	Intraoperative unfavourable incidents	During the surgical procedure

Collaborators and Investigators

• Sponsor: Fondazione Poliambulanza Istituto Ospedaliero
• Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna; Universita di Verona; University Hospital Southampton NHS Foundation Trust; The Queen Elizabeth Hospital; Amsterdam UMC location University of Amsterdam; Umberto I Mauriziano Hospital Turin; IRCCS San Raffaele Hospital Milan; University Hospital Padua; Riuniti Hospital Polytechnic University of Marche Ancona; Clinica Universidad de Navarra Pamplona; Groeninge Hospital Kortrijk; Oslo University Hospital and Institute of Medicine; Antoine Béclère Hospital Paris; Moscow Clinical Research Centre; Hospital Doctor Josep Trueta de Girona; Università Cattolica del Sacro Cuore-IRCCS Rome

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): July 10, 2022
• Study Completion (Actual): July 22, 2022

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: colorectal cancer; postoperative outcomes; synchronous colorectal liver metastases; simultaneous resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Hematinics; Liver Extracts
• Other Study ID Numbers: NP5467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The data of this study will be available from the corresponding author, Professor Mohammed Abu Hilal, upon reasonable request. The data are not publicly available since this could compromise the privacy of research participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No