NCT06200831

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
68mo left

Started Jun 2024

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jun 2024Dec 2031

First Submitted

Initial submission to the registry

December 13, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

5.6 years

First QC Date

December 13, 2023

Last Update Submit

July 28, 2025

Conditions

Colorectal CancerColorectal Neoplasms MalignantLiver Metastasis Colon CancerLiver Metastases

Outcome Measures

Primary Outcomes (1)

  • Comprehensive Complication Index, CCI

    The CCI is calculated as the sum of all complications that are weighted for their severity (multiplication of the median reference values from patients and physicians). The final formula yields a continuous scale to rank the severity of any combination of complications from 0 to 100 in a single patient.

    90 days

Secondary Outcomes (5)

  • Health Economics

    1 year

  • Overall survival

    3 and 5 years

  • Clavien Dindo Complications

    90 days

  • Quality of Life: EQ-5D

    Pre-operative, 30-days, 90-days, 6 months, 12 months

  • Quality of Life: EORTC QLQ-30

    Pre-operative, 30-days, 90-days, 6 months, 12 months

Study Arms (2)

Staged resection

ACTIVE COMPARATOR

Resection of the primary colorectal carcinoma and liver metastases in two separate surgeries.

Procedure: Staged resection

Simultaneous resection

EXPERIMENTAL

Resection of both the primary colorectal carcinoma and the liver metastases in one surgical procedure.

Procedure: Simultaneous resection

Interventions

Staged resectionPROCEDURE

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.

Also known as: Two-staged resection, Sequential resection
Staged resection
Simultaneous resectionPROCEDURE

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.

Also known as: Combined resection, Synchronous resection
Simultaneous resection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80 years old.
  • Both CRC and liver metastases in situ at time of evaluation.
  • Resectable primary tumor in the colon or upper rectum.
  • Less than 5 liver metastases, evaluated by the multidisciplinary tumor board meeting as possible to treat with surgical resection and/or ablation (RFA/MWA).

You may not qualify if:

  • Unresectable primary tumor.
  • Locally advanced primary tumor (T4).
  • Primary tumor in the lower rectum with indication for abdominoperineal resection.
  • Acute or imminent bowel obstruction.
  • Perforation or major bleeding from the primary tumor.
  • Pre-treatment of the primary tumor with a colon stent.
  • Liver resection requiring resection of more than 2 adjacent segments (Couinaud).
  • Liver metastases planned treated with irreversible electroporation (IRE).
  • Non-resectable lung metastases.
  • Metastases outside of liver (besides resectable lung metastases).
  • Eastern Cooperative Oncology Group (ECOG) Performance status ≥ 3.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Related Publications (3)

  • Kleive D, Aas E, Angelsen JH, Bringeland EA, Nesbakken A, Nymo LS, Schultz JK, Soreide K, Yaqub S. Simultaneous Resection of Primary Colorectal Cancer and Synchronous Liver Metastases: Contemporary Practice, Evidence and Knowledge Gaps. Oncol Ther. 2021 Jun;9(1):111-120. doi: 10.1007/s40487-021-00148-2. Epub 2021 Mar 23.

    PMID: 33759076BACKGROUND

  • Siriwardena AK, Serrablo A, Fretland AA, Wigmore SJ, Ramia-Angel JM, Malik HZ, Stattner S, Soreide K, Zmora O, Meijerink M, Kartalis N, Lesurtel M, Verhoef C, Balakrishnan A, Gruenberger T, Jonas E, Devar J, Jamdar S, Jones R, Hilal MA, Andersson B, Boudjema K, Mullamitha S, Stassen L, Dasari BVM, Frampton AE, Aldrighetti L, Pellino G, Buchwald P, Gurses B, Wasserberg N, Gruenberger B, Spiers HVM, Jarnagin W, Vauthey JN, Kokudo N, Tejpar S, Valdivieso A, Adam R; Joint E-AHPBA/ESSO/ESCP/ESGAR/CIRSE 2022 Consensus on colorectal cancer with synchronous liver metastases. The multi-societal European consensus on the terminology, diagnosis and management of patients with synchronous colorectal cancer and liver metastases: an E-AHPBA consensus in partnership with ESSO, ESCP, ESGAR, and CIRSE. HPB (Oxford). 2023 Sep;25(9):985-999. doi: 10.1016/j.hpb.2023.05.360. Epub 2023 Jul 13.

    PMID: 37471055BACKGROUND

  • Yaqub S, Margonis GA, Soreide K. Staged or Simultaneous Surgery for Colon or Rectal Cancer with Synchronous Liver Metastases: Implications for Study Design and Clinical Endpoints. Cancers (Basel). 2023 Apr 6;15(7):2177. doi: 10.3390/cancers15072177.

    PMID: 37046837BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Sheraz Yaqub, MD, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheraz Yaqub, MD PhD

CONTACT

+47-23073296shya@ous-hf.no

Frida B Hansen

CONTACT

frbhan@ous-hf.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2023

First Posted

January 11, 2024

Study Start

June 1, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2031

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)