Clinical trial · Interventional
Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases
Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases - A Multicentre Randomized Controlled Trial
NCT06200831CI-TRIAL-00092867SYLMETrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms Malignant | — | UNRESOLVED | — |
| Liver Metastases | — | UNRESOLVED | — |
| Liver Metastasis Colon Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simultaneous resection | Procedure | — | UNRESOLVED |
| Staged resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Staged resection
- description
- Resection of the primary colorectal carcinoma and liver metastases in two separate surgeries.
- interventionNames
- Procedure: Staged resection
- type
- EXPERIMENTAL
- label
- Simultaneous resection
- description
- Resection of both the primary colorectal carcinoma and the liver metastases in one surgical procedure.
- interventionNames
- Procedure: Simultaneous resection
Primary outcomes (1)
- measure
- Comprehensive Complication Index, CCI
- timeFrame
- 90 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
References
Publications (3)
- BACKGROUNDKleive 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 33759076
- BACKGROUNDSiriwardena 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 37471055
- BACKGROUNDYaqub 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 37046837