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The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery.
Liver malignancies is a major cause of cancer-related mortality and the incidence is increasing. Patients with liver malignancies are often left with limited surgical treatment options due to extensive tumor burden or comorbidities. Ablation is a less invasive treatment for these patients that can be performed percutaneously, by laparoscopy or open surgery. Ablation during open surgery has a high potential of complications. Laparoscopic ablation presumably has a lower complication rate than during open surgery, yet still offers some of the same advantages needed for tumors in locations not favorable for percutaneous ablation. This study aims to compare laparoscopic ablation with ablation during open surgery to investigate a treatment option with a supposed lower complication rate and equally treatment effectiveness after one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open ablation | Active Comparator | Laparotomy performed for open ablation of the tumor |
|
| Laparoscopic ablation | Experimental | Ablation of the tumor performed by laparoscopic approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic ablation | Procedure | Heat-based ablation modality performed by laparoscopy. Centers may use either radiofrequency or microwave ablation. The modality should be the same in both groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications measured by the comprehensive complication index. | Comprehensive Complication Index (CCI) scores compared between open and laparoscopic ablation groups. A higher CCI score represents a larger complication burden. | Complications are registered and clavien-dindo graded 30 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor ablation completeness. | Presence of tumor remnants in ablation cavity one month after procedure evaluated with contrast enhanced CT. | 30 days after surgery. |
| Quality of Recovery score (QoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucas Alexander Knøfler, MD | Contact | +4520114529 | lucas.alexander.knoefler@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Hans-Christian Pommergaard, MD DMSc PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41736646 | Derived | Knofler LA, Klubien J, Larsen PN, Kiim KS, Fukumori D, Tschuor C, Nielsen SD, Pommergaard HC. Open versus laparoscopic ablation of liver malignancies - a protocol for a randomised clinical trial. Dan Med J. 2026 Jan 14;73(2):A04250305. doi: 10.61409/A04250305. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2023 | Oct 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation after operability assesment.
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| Open ablation | Procedure | Heat-based ablation modality performed by laparotomy. Centers may use either radiofrequency or microwave ablation. The modality should be the same in both groups. |
|
Questionnaires are filled out prior to surgery and after
| Before surgery and postoperative day 1, 7 and 30. |
| Quality of Life score (QoL) | Questionnaires are filled out prior to surgery and after | Before surgery and on postoperative day 30. |
| Overall survival | Overall and disease-free survival measured as survival status 90 days after surgery. | Up to 90 days after surgery |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |