Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200831
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2023-12-13
Brief Title:
Simultaneous vs Staged Resection of Colorectal Cancer With Synchronous Liver Metastases
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Simultaneous vs Staged Resection of Colorectal Cancer With Synchronous Liver Metastases - A Multicentre Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SYLMET
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 endpointsThis 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 andor ablation RFAMWA at time of evaluation
Detailed Description:
Colorectal cancer CRC represents the second most common cause of cancer and cancer death in Norway and the incidence is increasing Cancer in Norway 2021 Cancer Registry of Norway The liver is the most common site of metastasis from CRC More than 4500 individuals are diagnosed with CRC in Norway each year and approximately 20 of patients present with liver metastases at time of diagnosis synchronous metastases Resection of both the primary tumor and liver metastases is considered the only curative treatment and has been shown to improve long-term survival and is considered standard of care However the optimal timing of surgical resection of synchronous liver metastases in relation to the primary tumor is not well defined Traditionally staged resection has been preferred ie resection of the primary tumour and liver metastases on separate admissions with a period of recovery between the two operations whereas simultaneous resection is appealing ie resection of both primary and metastases in one operative session Despite a lack of randomized controlled trials comparing these two surgical approaches the number of simultaneous resections has increased at several institutions The evolvement of both liver and colorectal surgery in the last decades has led to reduced complications making simultaneous resections more feasible Previous retrospective cohort studies and meta-analyses suggest that simultaneous and staged approach carry similar postoperative complication and perioperative mortality rates as well as long-term survival A recently published prospective observational study on staged or simultaneous surgery reported similar outcomes in selected patients To date there is only one published randomized controlled trial which was aborted after inclusion of half of the sample size after an accrual time of 10 years18 Due to lack of evidence the majority of surgical societies worldwide still treats this patient group with staged resections resulting in two hospital admissions two rounds of general anaesthesia and surgery and finally two episodes of postoperative recovery and rehabilitation If this trial demonstrates that simultaneous surgery is safe feasible and cost-effective it will potentially have a practice-changing impact worldwide
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None