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Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases

NCT06200831 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-31

No results posted yet for this study

Summary

The SYLMET Trial is a randomized trial to compare simultaneous and two-staged resection of primary colorectal and synchronous liver metastases. This is an investigator-initiated, multicentre, randomized controlled trial to assess complications (primary endpoint), survival, cost-effectiveness, and quality of life (secondary endpoints).This trial will include patients with resectable primary tumour in the colon or upper rectum with less than five liver metastases that is possible to treat with surgical resection and/or ablation (RFA/MWA) at time of evaluation.

Conditions

  • Colorectal Cancer
  • Colorectal Neoplasms Malignant
  • Liver Metastasis Colon Cancer
  • Liver Metastases

Interventions

PROCEDURE

Staged resection

Patients randomized to staged resection will be operated according to the decision made by the tumor board meeting (liver or colorectal cancer first, based on tumor burden and symptoms), but both resections have to be done within a time period of 4-12 weeks.

PROCEDURE

Simultaneous resection

In cases with simultaneous surgery, the liver resection is performed prior to colon resection in order to keep a low central venous pressure during the first part of the surgical procedure and to avoid congestion of the anastomosis line owing to possible Pringle manoeuvre.

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Helse Stavanger HF

    collaborator OTHER_GOV

  • University Hospital, Akershus

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Sheraz Yaqub, MD, PhD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2029-12-31
Completion
2031-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06200831 on ClinicalTrials.gov