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

NCT07564284 | Not Yet Recruiting

• 1 other identifier: 2025-00266-01
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Metastases From Colorectal Cancer

Keywords

Liver metastases; Colorectal cancer; Multidisciplinary management; Surgical strategy; Simultaneous resection; Liver first; Bowel first; Staged resections; Survival; Quality of life; Healthcare Costs; Cost-Effectiveness; Health Literacy

Outcome Measures

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.

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

Secondary Outcomes (9)

• Overall Survival

  Time frame: 3 and 5 years from diagnosis

• Recurrence-Free Survival

  3 and 5 years from completion of treatment.

• 90-Day Mortality

  90 days from first surgery.

• 30-Day Readmission

  30 days from each surgical procedure.

• Major complications

  30 and 90 days from each surgical procedure

Study Arms (1)

Synchronous colorectal liver metastases

Simultaneous Resection, Bowel-First Staged Resection, Liver-First Staged Resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• Discussed at a hepatobiliary and/or colorectal multidisciplinary team (MDT) meeting
• Planned curative treatment of both the primary colorectal tumor AND the liver metastases (by resection, ablation, or transplantation)
• Planned curative treatment of any extrahepatic disease, if present

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jennie Engstrand, Md, PhD

CONTACT

+46 8 123 800 00; jennie.engstrand@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04