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Patient Eligibility Criteria & Randomization

Inclusion criteria

Patients with CRLM qualifying for surgery and fulfilling all of the following inclusion criteria may be enrolled in the study:

  • Male or female patients above 18 years of age.

  • Patients with multifocal CRLM with a FLR/TLV< 30% OR a FLR/BW ratio of < 0.5.

  • Patients with colorectal primary tumor not yet resected may be included as long as the extrahepatic disease may be cured surgically (liver first strategy).

  • Patients with lung metastases may be included in the study as long as the lung metastases are potentially curable by resection by judgment of a thoracic surgery consultant.

  • Chemotherapy response according to RECIST: regression or stable disease.

  • The indication for surgery should be discussed at a multidisciplinary tumor board attended by hepatobiliary surgeons, oncologists, hepatologists and radiologists.

  • Written informed consent given by the patient after discussing the trial with the patient in a language he/she understands.

  • Women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during the 12 months thereafter. A negative pregnancy test before inclusion into the trial is required for women, who are not yet menopausal, had their last menses within less than 12 months, have not had uterus and or ovaries removed surgically or undergone tubal ligation.


Exclusion criteria

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

  • Male or female patients under 18 years of age.

  • Unilobar tumorload qualifying the patient for a standard hepatectomy.

  • Patients with multifocal CRLM with a FLR/TLV > 30% OR a FLR/BW ratio of > 0.5.

  • Patients with a baseline sFLR of less than 15%.

  • Patients with extrahepatic metastatic disease (except potentially resectable lung metastases).

  • Patients not having received chemotherapy before study enrollment.

  • Fibrosis Metavir stage ≥F3 or >30% macrosteatosis in liver biopsy prior to enrollment or liver biopsy at beginning of stage I procedure.

  • Significant concomitant diseases making the patient unsuitable for major liver surgery by the judgment of the physicians involved.

  • Known or suspected non-compliance (e.g. drug- and/or alcohol abuse).

  • Enrollment into a clinical trial interfering with the endpoints.

  • Intention to become pregnant during the course of the study.

  • Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.

  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

  • Previous enrolment into the current study

There is no inclusion of vulnerable patient groups planned.


Randomization & Blinding

Randomization will be performed intraoperatively after laparoscopic or open surgical exploration and liver biopsy without pre-stratification. Block randomization will be used since this is a multicentric trial avoiding a center-bias. Exclusion of patients is possible after exploration and liver biopsy. Randomization will be performed by the PI or a designated deputy (investigator) using the randomization software implemented in the CRF database (Secutrial®) after exploration.

Blinding is applicable to the radiologists assessing the primary study- endpoint (disease free measured by PET CT or CT Thorax Abdomen). However, surgeons performing the study intervention will be mostly investigators and are therefore not blinded. Study participants will also not be blinded.


University Hospital Zurich
Department of Surgery
Raemistrasse 100
8091 Zurich, Switzerland


Phone: +41 (0)44 255 33 00
Fax:     +41 (0)44 255 44 49