Colorectal Cancer MetastaticSIMULTNCT05475041
Perioperative Outcomes of Simultaneous Colorectal and Liver Resections
An observational study of Colorectal Cancer Metastatic and Surgical Procedure, Unspecified, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Surgical Procedure, Unspecified
- What is being tested?
- Major liver resection and Technically major liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 766 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2022to 22 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Elective minimally invasive or open simultaneous resection of colorectal cancer and synchronous colorectal liver metastases
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Lombardy, 25124
About this study
Official title: 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.
- Being tested
- Major liver resection, Technically major liver resection
- Keywords
- colorectal cancer, synchronous colorectal liver metastases, simultaneous resection, postoperative outcomes
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major liver resectionProcedure or surgery
Major liver resection (3 or more contiguous segments)
Technically major liver resectionProcedure or surgery
Minor liver resection (<3 contiguous segments) in the posterosuperior segments (segment 1,4a,7,8)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Technically major liver resection | |
| Major liver resection | Major liver resection (3 or more contiguous segments) Receives: Procedure: Major liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complications
Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure
Measured: 30 days postoperatively
Secondary outcomes (9)
Overall complications
Overall complications related to the surgical procedure
Measured: 30 days postoperatively
Length of hospital stay
The length of hospital stay for the surgical procedure
Measured: 30 days postoperatively
R0 resection margin
Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.
Measured: 30 days postoperatively
Intraoperative blood loss
Intraoperative blood loss in milliliters
Measured: During the surgical procedure
Operative time
Operative time in minutes
Measured: During the surgical procedure
Conversion to open surgery
Intra-operative conversion to an open or hand-assisted procedure in the minimally invasive group
Measured: During the surgical procedure
Mortality
Postoperative mortality
Measured: 90 days postoperatively
Red blood cell transfusion
Intraoperative red blood cell transfusion
Measured: During the surgical procedure
Intraoperative incidents
Intraoperative unfavourable incidents
Measured: During the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start30 Jun 2022
- Primary completion10 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 766 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Collaborators
- University of Amsterdam, Universita di Verona, Umberto I Mauriziano Hospital Turin, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS San Raffaele, University Hospital Padua, Riuniti Hospital Polytechnic University of Marche Ancona, Clinica Universidad de Navarra, Universidad de Navarra, Groeninge Hospital Kortrijk, Oslo University Hospital and Institute of Medicine, The Queen Elizabeth Hospital, Antoine Béclère Hospital Paris, Moscow Clinical Research Centre, University Hospital of Girona Dr. Josep Trueta, University Hospital Southampton NHS Foundation Trust, Catholic University of the Sacred Heart
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475041
- Sponsor's protocol ID
- NP5467
- Acronym
- SIMULT
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Sijberden JP, Zimmitti G, Conci S, Russolillo N, Masetti M, Cipriani F, Lanari J, Gorgec B, Benedetti Cacciaguerra A, Rotellar F, D'Hondt M, Edwin B, Sutcliffe RP, Dagher I, Efanov M, Lopez-Ben S, Primrose JN, Giuliante F, Spinelli A, Chand M, Alvarez S, Langella S, Nicosia S, Ruzzenente A, Vivarelli M, Cillo U, Aldrighetti L, Jovine E, Ferrero A, Guglielmi A, Besselink MG, Abu Hilal M. Simultaneous resection of colorectal cancer and synchronous liver metastases: what determines the risk of unfavorable outcomes? An international multicenter retrospective cohort study. Int J Surg. 2023 Mar 1;109(3):244-254. doi: 10.1097/JS9.0000000000000068.
PubMed 37093069
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Resection of Colorectal Cancer and Synchronous Liver Metastases: What Determines the Risk of Unfavorable Outcomes? A Retrospective International Multicenter Study
- ClinicalTrials.gov ID
- NCT05475041
- Acronym / sponsor ID
- SIMULT / NP5467
- Keywords
- colorectal cancer, synchronous colorectal liver metastases, simultaneous resection, postoperative outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 766 participants (actual)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Collaborators
- University of Amsterdam, Universita di Verona, Umberto I Mauriziano Hospital Turin, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS San Raffaele, University Hospital Padua, Riuniti Hospital Polytechnic University of Marche Ancona, Clinica Universidad de Navarra, Universidad de Navarra, Groeninge Hospital Kortrijk, Oslo University Hospital and Institute of Medicine, The Queen Elizabeth Hospital, Antoine Béclère Hospital Paris, Moscow Clinical Research Centre, University Hospital of Girona Dr. Josep Trueta, University Hospital Southampton NHS Foundation Trust, Catholic University of the Sacred Heart
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Minor liver resection | – | –Minor liver resection (<3 contiguous segments) in the anterolateral segments |
| Technically major liver resection | – | Procedure: Technically major liver resectionMinor liver resection (<3 contiguous segments) in the posterosuperior segments (Segment 1,4a,7,8) |
| Major liver resection | – | Procedure: Major liver resectionMajor liver resection (3 or more contiguous segments) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Elective minimally invasive or open simultaneous resection of colorectal cancer and synchronous colorectal liver metastases
Key exclusion criteria (3 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Major liver resectionMajor liver resection (3 or more contiguous segments) | Procedure or surgery | Major liver resection |
| Technically major liver resectionMinor liver resection (<3 contiguous segments) in the posterosuperior segments (segment 1,4a,7,8) | Procedure or surgery | Technically major liver resection |
Primary outcome
Major complications
Time frame: 30 days postoperatively
Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure
9 secondary outcomes
Overall complications
Time frame: 30 days postoperatively
Length of hospital stay
Time frame: 30 days postoperatively
R0 resection margin
Time frame: 30 days postoperatively
Intraoperative blood loss
Time frame: During the surgical procedure
Operative time
Time frame: During the surgical procedure
Conversion to open surgery
Time frame: During the surgical procedure
Mortality
Time frame: 90 days postoperatively
Red blood cell transfusion
Time frame: During the surgical procedure
Intraoperative incidents
Time frame: During the surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 37093069Sijberden JP, Zimmitti G, Conci S, Russolillo N, Masetti M, Cipriani F, Lanari J, Gorgec B, Benedetti Cacciaguerra A, Rotellar F, D'Hondt M, Edwin B, Sutcliffe RP, Dagher I, Efanov M, Lopez-Ben S, Primrose JN, Giuliante F, Spinelli A, Chand M, Alvarez S, Langella S, Nicosia S, Ruzzenente A, Vivarelli M, Cillo U, Aldrighetti L, Jovine E, Ferrero A, Guglielmi A, Besselink MG, Abu Hilal M. Simultaneous resection of colorectal cancer and synchronous liver metastases: what determines the risk of unfavorable outcomes? An international multicenter retrospective cohort study. Int J Surg. 2023 Mar 1;109(3):244-254. doi: 10.1097/JS9.0000000000000068.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Colorectal Cancer Metastatic
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic and Surgical Procedure, Unspecified, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major complications (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05475041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.