Liver-First, Bowel-First, or Simultaneous Resection for Synchronous Colorectal Liver Metastases: Outcomes, Quality of Life, and Cost-Effectiveness

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

The goal of this observational study is to learn about treatment outcomes, quality of life, and healthcare costs in patients with colorectal cancer who have liver metastases detected at the same time as their primary tumor (synchronous colorectal liver metastases, CRLM). The main questions it aims to answer are:

Do patients who undergo simultaneous removal of both the bowel tumor and liver metastases in one operation differ in their ability to complete the intended treatment compared to patients who undergo staged operations (bowel first or liver first)? Does the choice of surgical strategy affect quality of life and healthcare costs?

Patients with synchronous CRLM discussed at a multidisciplinary team meeting at participating Swedish university hospitals will be followed prospectively for up to 5 years. Treatment is not influenced by the study - all surgical decisions are made as part of routine clinical care. Patients in the quality-of-life sub-study will complete validated questionnaires (EORTC QLQ-C30, QLQ-LM21, and QLQ-CR29) at multiple time points from diagnosis through 36 months. Healthcare costs and health literacy will also be assessed in parallel sub-studies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age over 18 years

Histologically proven colorectal cancer

Radiological evidence of liver metastases (contrast-enhanced CT or MRI), detected prior to resection of the primary colorectal tumor

Primary colorectal tumor (colon or rectum) in situ at time of inclusion

Disqualifiers

Unable to give informed consent (Studies 4-6 only; opt-out applies to Study 3)

Untreatable extrahepatic metastases at the discretion of the MDT

Not scheduled for curative resection of both the primary tumor and liver metastases

Emergency resection of the primary tumor performed prior to MDT referral

Trial population

Patients with synchronous colorectal liver metastases (CRLM) discussed at a hepatobiliary and/or colorectal multidisciplinary team (MDT) meeting at participating Swedish university hospitals. The population includes all patients in whom curative treatment of both the primary colorectal tumor and liver metastases is considered feasible by the MDT, irrespective of WHO performance status, suitability for chemotherapy, prior history of malignancy, or the presence of treatable extrahepatic disease. Patients are identified consecutively at MDT meetings.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Synchronous colorectal liver metastases

Trial outcomes

Primary outcomes

1

Failure to Return to Intended Oncological Treatment (RIOT)

The proportion of patients who do not complete their planned surgical treatment pathway, and the reasons for failure. In staged resections, this most commonly occurs when disease progression during the interval between operations renders the second operation unfeasible.

Time frame
From date of MDT discussion to completion of intended treatment, assessed up to 24 months.

Secondary outcomes

1

Overall Survival

Survival assessed from the date of diagnosis of the primary colorectal tumor

Time frame
Time frame: 3 and 5 years from diagnosis
2

Recurrence-Free Survival

Defined as the absence of tumor or metastases on a CT scan undertaken after completion of all intended treatment (both liver and primary tumor resection).

Time frame
3 and 5 years from completion of treatment.
3

90-Day Mortality

Death from any cause within 90 days of the first surgical procedure.

Time frame
90 days from first surgery.
4

30-Day Readmission

Unplanned hospital readmission within 30 days of any surgical procedure.

Time frame
30 days from each surgical procedure.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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