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| Name | Class |
|---|---|
| Helse Sor-Ost | OTHER_GOV |
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The purpose of the study is to compare outcomes of laparoscopic versus open liver resection for colorectal metastases in a prospective and randomized study. The study will include all non-anatomic liver resections in our institution.
The primary end point is that the use of laparoscopic technique significantly can reduce the frequency of complications to liver resection. Secondary end points are 5-year survival, immediate surgical outcomes, quality of life and degree of impairment of the immune system.
Full protocol is published open access in Trialsjournal:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open liver resection | Active Comparator | Patients will be operated with open liver resection |
|
| Laparoscopic liver resection | Active Comparator | Patients will be operated with laparoscopic liver resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open liver resection | Procedure | Patients will be operated with open liver resection for colorectal metastasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30 Days Perioperative Morbidity | This study aims to compare major intraoperative and postoperative parameters in patients randomized to either laparoscopic or open liver resection. Pre- and perioperative events relevant for surgical outcomes will be registered. The following intraoperative parameters will be compared: operative time, blood loss, blood transfusion, while intraoperative incidents will be classified according to the Satava classification. Morbidity within the first 30 days is the primary outcome (morbidity, yes/no), and will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al, by the Accordion system and by the Comprehensive Complication Index | Within 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 5 Year Survival | 5 year survival
| 5 years after surgery |
| Recurrence Pattern | Pattern of recurrence in liver and extrahepatic. Studied by postoperative CT every 4 months for 2 years and every 6 months for the following 3 years. Local recurrence and new tumors will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bjørn Edwin, MD, PhD | Oslo University Hospital - The Interventional Centre | Study Chair |
| Bjorn Edwin, MD, PhD | Oslo University Hospital - The Interventional Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41686533 | Derived | Drejian S, Akhavi MS, Grzyb K, Kazaryan A, Fretland AA, Edwin B, Aghayan D. Histopathologic growth patterns as prognostic factor for survival in patients with colorectal liver metastases. Radiol Oncol. 2026 Feb 6;60(1):114-123. doi: 10.2478/raon-2026-0002. eCollection 2026 Mar 1. | |
| 33197213 | Derived | Aghayan DL, Kazaryan AM, Dagenborg VJ, Rosok BI, Fagerland MW, Waaler Bjornelv GM, Kristiansen R, Flatmark K, Fretland AA, Edwin B; OSLO-COMET Survival Study Collaborators. Long-Term Oncologic Outcomes After Laparoscopic Versus Open Resection for Colorectal Liver Metastases : A Randomized Trial. Ann Intern Med. 2021 Feb;174(2):175-182. doi: 10.7326/M20-4011. Epub 2020 Nov 17. |
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Not decided yet but results will be public no matter the outcome of the trial
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Liver Resection | Patients will be operated with open liver resection Open liver resection: Patients will be operated with open liver resection for colorectal metastasis |
| FG001 | Laparoscopic Liver Resection | Patients will be operated with laparoscopic liver resection Laparoscopic liver resection: Patients will be operated with laparoscopic liver resection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 280 patients were enrolled. Only 273 underwent surgery, and only these could reach the primary endpoint of 30 days morbidity. This is why there is a difference between baseline and analyzed for the primary endpoint.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Liver Resection | Patients will be operated with open liver resection Open liver resection: Patients will be operated with open liver resection for colorectal metastasis |
| BG001 | Laparoscopic Liver Resection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 30 Days Perioperative Morbidity | This study aims to compare major intraoperative and postoperative parameters in patients randomized to either laparoscopic or open liver resection. Pre- and perioperative events relevant for surgical outcomes will be registered. The following intraoperative parameters will be compared: operative time, blood loss, blood transfusion, while intraoperative incidents will be classified according to the Satava classification. Morbidity within the first 30 days is the primary outcome (morbidity, yes/no), and will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al, by the Accordion system and by the Comprehensive Complication Index | Modified intention to treat | Posted | Number | Complications Accordion grade 2 or highe | Within 30 days after surgery |
|
30 days
Adverse events were systematically collected using the Accordion system
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Liver Resection | Patients will be operated with open liver resection Open liver resection: Patients will be operated with open liver resection for colorectal metastasis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aasmund A. Fretland | Oslo University Hospital | 004723070100 | aafret@ous-hf.no |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| Laparoscopic liver resection | Procedure | Patients will be operated with laparoscopic liver resection |
|
|
| 5 years |
| Immediate Oncologic Outcome | Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins. | 2 months after surgery |
| Postoperative Quality of Life | Evaluation of postoperative quality of life at baseline, 1 month, 4 months and 2 years using the SF-36 and the EORTC qlq-30 lmc-21 forms | Up to 2 years |
| Surgical Trauma and Activation of the Immune System | Evaluation of surgical trauma caused by open and laparoscopic resection by means of analyzing complement and cytokine activation at set perioperative time points. | 72 hours |
| Health Economy | We intend to compare overall cost of treatment for the hospital and for the health care system | 1 year |
| Severity of Postoperative Pain | To compare pain the first 5 postoperative days, at 1 month and 4 months. Patients in the open group will be randomized to receiving either a patient controlled analgesic pump containing opioids, or a patient controlled epidural analgesic pump. In laparoscopic group all patients will receive a PCA. | 4 months |
| Molecular Biology | The aim is to perform molecular characterization of biological samples harvested perioperatively and during follow-up, and to correlate results with clinical end points. | 20 years |
| Anti-tumor Immunology | The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors | 20 years |
| Imaging | The aim is to evaluate two new imaging methods, CT perfusion of liver and LIME-PET, in order to optimize the preoperative identification of colorectal liver metastases. | 5 years |
| Severity of Morbidity | Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system | 30 days |
| Level of Adhesions | Level of adhesions will be recorded during repeated liver resection in patients formerly randomized to open or laparoscopic liver resection. a modified version of the peritoneal adhesion index will be used for scoring. | 2 years |
| Number of Patients That Complete Adjuvant Oncologic Treatment | Time from operation to initiation of oncologic treatment, and the total number of courses given will be recorded and compared between the groups. | 1 year |
| Readmissions | Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals. | 30 days |
| Incidence of Incisional Hernia | CT scans will be performed to examine for incisional hernia 1 year after surgery | 1 year |
| 31322735 | Derived | Fretland AA, Dagenborg VJ, Waaler Bjornelv GM, Aghayan DL, Kazaryan AM, Barkhatov L, Kristiansen R, Fagerland MW, Edwin B, Andersen MH. Quality of life from a randomized trial of laparoscopic or open liver resection for colorectal liver metastases. Br J Surg. 2019 Sep;106(10):1372-1380. doi: 10.1002/bjs.11227. Epub 2019 Jul 19. |
| 25872027 | Derived | Fretland AA, Kazaryan AM, Bjornbeth BA, Flatmark K, Andersen MH, Tonnessen TI, Bjornelv GM, Fagerland MW, Kristiansen R, Oyri K, Edwin B. Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet Study): study protocol for a randomized controlled trial. Trials. 2015 Mar 4;16:73. doi: 10.1186/s13063-015-0577-5. |
Patients will be operated with laparoscopic liver resection
Laparoscopic liver resection: Patients will be operated with laparoscopic liver resection
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Region of enrollment is Norway | Count of Participants | Participants |
|
Patients will be operated with open liver resection
Open liver resection: Patients will be operated with open liver resection for colorectal metastasis
| OG001 | Laparoscopic Liver Resection | Patients will be operated with laparoscopic liver resection Laparoscopic liver resection: Patients will be operated with laparoscopic liver resection |
|
|
| Secondary | 5 Year Survival | 5 year survival
| Not Posted | 5 years after surgery | Participants |
| Secondary | Recurrence Pattern | Pattern of recurrence in liver and extrahepatic. Studied by postoperative CT every 4 months for 2 years and every 6 months for the following 3 years. Local recurrence and new tumors will be recorded. | Not Posted | 5 years | Participants |
| Secondary | Immediate Oncologic Outcome | Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins. | Not Posted | 2 months after surgery | Participants |
| Secondary | Postoperative Quality of Life | Evaluation of postoperative quality of life at baseline, 1 month, 4 months and 2 years using the SF-36 and the EORTC qlq-30 lmc-21 forms | Not Posted | Up to 2 years | Participants |
| Secondary | Surgical Trauma and Activation of the Immune System | Evaluation of surgical trauma caused by open and laparoscopic resection by means of analyzing complement and cytokine activation at set perioperative time points. | Not Posted | 72 hours | Participants |
| Secondary | Health Economy | We intend to compare overall cost of treatment for the hospital and for the health care system | Not Posted | 1 year | Participants |
| Secondary | Severity of Postoperative Pain | To compare pain the first 5 postoperative days, at 1 month and 4 months. Patients in the open group will be randomized to receiving either a patient controlled analgesic pump containing opioids, or a patient controlled epidural analgesic pump. In laparoscopic group all patients will receive a PCA. | Not Posted | 4 months | Participants |
| Secondary | Molecular Biology | The aim is to perform molecular characterization of biological samples harvested perioperatively and during follow-up, and to correlate results with clinical end points. | Not Posted | 20 years | Participants |
| Secondary | Anti-tumor Immunology | The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors | Not Posted | 20 years | Participants |
| Secondary | Imaging | The aim is to evaluate two new imaging methods, CT perfusion of liver and LIME-PET, in order to optimize the preoperative identification of colorectal liver metastases. | Not Posted | 5 years | Participants |
| Secondary | Severity of Morbidity | Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system | Not Posted | 30 days | Participants |
| Secondary | Level of Adhesions | Level of adhesions will be recorded during repeated liver resection in patients formerly randomized to open or laparoscopic liver resection. a modified version of the peritoneal adhesion index will be used for scoring. | Not Posted | 2 years | Participants |
| Secondary | Number of Patients That Complete Adjuvant Oncologic Treatment | Time from operation to initiation of oncologic treatment, and the total number of courses given will be recorded and compared between the groups. | Not Posted | 1 year | Participants |
| Secondary | Readmissions | Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals. | Not Posted | 30 days | Participants |
| Secondary | Incidence of Incisional Hernia | CT scans will be performed to examine for incisional hernia 1 year after surgery | Not Posted | 1 year | Participants |
| 1 |
| 147 |
| 10 |
| 147 |
| 0 |
| 147 |
| EG001 | Laparoscopic Liver Resection | Patients will be operated with laparoscopic liver resection Laparoscopic liver resection: Patients will be operated with laparoscopic liver resection | 0 | 133 | 4 | 133 | 0 | 133 |
| Suspected bowel perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| Fascia dehiscence | Gastrointestinal disorders | Systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Pulmonary embolism | Blood and lymphatic system disorders | Systematic Assessment |
|
| Small bowel perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Sudden death | General disorders | Systematic Assessment |
|
| Intraabdominal abcess | Gastrointestinal disorders | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D055585 |
| Physical Phenomena |