Open Versus Laparoscopic Ablation of Liver Malignancies

NCT06304766 | Recruiting

• 1 other identifier: H-23015954
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; Cholangiocarcinoma; Liver Metastases

Keywords

Laparoscopic ablation; Open ablation; Complications; Ablation response; Quality of life; Randomized; Multicenter

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Tumor ablation completeness.

  30 days after surgery.

• Quality of Recovery score (QoR)

  Before surgery and postoperative day 1, 7 and 30.

• Quality of Life score (QoL)

  Before surgery and on postoperative day 30.

• Overall survival

  Up to 90 days after surgery

Study Arms (2)

Open ablation

ACTIVE COMPARATOR

Laparotomy performed for open ablation of the tumor

Procedure: Open ablation

Laparoscopic ablation

EXPERIMENTAL

Ablation of the tumor performed by laparoscopic approach

Procedure: Laparoscopic ablation

Interventions

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.

Laparoscopic ablation

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.

Open ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One or more tumors not amenable to percutaneous ablation, age ≥ 18, signed informed consent, diagnosis of primary liver cancer or liver metastases from any primary tumor, and tumor suitable for ablation as primary treatment.

You may not qualify if:

• Ablation performed in conjunction with resection, patients who cannot cooperate with the study, and patients who do not understand or speak Danish.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Hans-Christian Pommergaard, MD DMSc PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas Alexander Knøfler, MD

CONTACT

+4520114529; lucas.alexander.knoefler@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc, PhD, Clinical Research Associate Professor

Model Details: Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation after operability assesment.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: March 12, 2024
• Study Start: December 15, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)