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COLDFIRE-2 study: Colorectal metastatic liver disease: efficacy of irreversible electroporation (IRE) - a phase II clinical trial

The primary objective of this project is to evaluate the primary and secondary technique effectiveness of IRE for centrally located colorectal liver metastases that are neither amenable for resection nor for other local ablation methods due to the…

Cone-beam CT guided Stereotactic Radiation Therapy for Locally Advanced and Locally Recurrent Pancreatic Cancer

To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced and locally recurrent pancreatic carcinoma.

Irreversible Electroporation for treatment of unresectable, locally advanced pancreatic cancer in the Leiden University Medical Centre: a phase I/II study.

Main objectiveTo investigate feasibility and safety of tumor ablation using IRE in patients with irresectable locally advanced pancreatic head carcinomas.Secondary objective(s)To investigate tumor downstaging efficacy, pain perception and hospital…

A Phase 2 , Randomized , Single - Blind , Controlled , Comparative Efficacy and Safety Study of Topical Fibrocaps * and Gelatin Sponge in Surgical hemostasis in the Netherlands

1. To characterize the efficacy of topical Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, in surgical subjects when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical2. To…

Pilot study: The use of PET-MRI in the follow-up of RFA treated colorectal liver metastases

The primary objective of this study is to evaluate the ability of PET-MRI to detect LSR during the first year of follow-up after RFA treatment of CRLM as compared with ceCT and PET-CT. Standard reference will be histology (when available) or…

A prospective, non-controlled, open-label study to assess the safety and effectiveness of Fibrocaps* in subjects undergoing liver resection.

The primary objective of this trial is to investigate the safety of Fibrocaps* in subjects undergoing liver resection.The secondary objective of this study is to investigate the effectiveness of Fibrocaps* on time to achieve haemostasis and volume…

Identification of predictive factors for response to neo-adjuvant Sunitinib in patients with resectable hepatocellular carcinoma

To identify predictive factors for response to sunintib treatment in patients with HCC. By discovering changes in pathways involved in HCC carcinogenesis due to sunitinib treatment in tissue/biomarkers and to correlate these changes to FDG-PET scan…

The use of covered expandable stents with a proximal lasso to resolve benign post-surgical biliary strictures

To investigate feasibility, safety, and effectiveness of covered expandable stents with a proximal lasso to resolve benign post-surgical strictures.

Fase I/II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating irresectable liver metastases

Primary objective * To determine the overall response rate of two PHP with an interval of at least 6 weeks and 3 mg/kg melphalan in irresectable liver metastases patients.* To determine the percentage of patients qualifying for resection. Secondary…

Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases - a feasibility study

Primary Objective: The first objective of this study is to evaluate the safety and feasibility of adjuvant HAIP chemotherapy after resection of CLM in 2 centres in the Netherlands.Secondary Objective(s): The second objective is to determine whether…

Ablation zone delineation with MRI during thermal ablation of liver tumours

To assess the feasibility of real-time MRI temperature monitoring and ablation zone assessment during thermal ablation of liver tumours.

Hepatic arterial infusion pump chemotherapy in patients with unresectable intrahepatic cholangiocarcinoma

The aim of the study is to demonstrate that HAIP chemotherapy is an effective treatment for unresectable intrahepatic cholangiocarcinomas.

Selective Indocyanine Green Injection of a Segmental Hepatic Artery Followed by Near-Infrared Fluorescence
Guided Anatomical Liver Resection: A Feasibility Study

Primary objective: To investigate the feasibility of using intraarterial ICG preoperatively to allow for liver segment visualization during anatomical liver resection.Secondary Objective(s): 1. To investigate the dosage which provides sufficient…

Adjuvant hepatic arterial infusion pump chemotherapy after repeat hepatectomy for patients with recurrent colorectal liver metastases without a history of extrahepatic disease - a phase II study

Primary Objective: The first objective of this study is to evaluate efficacy of adjuvant HAIP chemotherapy after repeat hepatectomy for recurrent CRLM in the Erasmus MC.Secondary Objective(s): The second objective is to determine treatment related…

Fluorescence-guided resection Of Colorectal liver metastases Using SGM-101 and Indocyanine GREEN.

To assess the feasibility of simultaneous use of ICG and SGM-101 for intraoperative imaging of colorectal liver metastases.

Radioembolization with 166Ho-microspheres in elderly and/or fragile patients with previously untreated unresectable liver-only metastases of colorectal cancer, CAIRO7 study endorsed by the Dutch Colorectal Cancer Group (DCCG)

Primary objective:The objective of this randomized phase 2 study is to demonstrate efficacy of RE in terms of PFS in colorectal cancer patients with liver-only metastases who are candidates for palliative systemic treatment with capecitabine plus…

Hepatic arterial infusion PUMP chemotherapy combined with systemIc chemoTherapy for potentially resectable colorectal liver metastases

This study has been transitioned to CTIS with ID 2024-515525-28-00 check the CTIS register for the current data. The aim of this study is to prove feasibility of HAIP chemotherapy (floxuridine) in combination with standard systemic chemotherapy…

Single-arm, phase II trial of trifluridine/tipiracil (FTD-TPI), bevacizumab, and individualized radioembolization with 166Ho-microspheres in refractory metastatic colorectal cancer.

To determine safety, tolerability, and activity of individualized radioembolization with 166Ho-microspheres combined with FTD-TPI and bevacizumab.

Perivascular and peribiliary colorectal liver metastases (0-5 cm): irreversible electroporation versus stereotactic body radiotherapy.

The primary objective of this study is to compare efficacy of IRE to the efficacy of SBRT regarding the primary endpoint (local control at 2 years) in patients with perivascular and peribiliary CRLM (0-5 cm). The CRLM are unsuitable for surgery and…

A Randomized Phase II Study of Systemic Chemotherapy with or without HAI FUDR/Dexamethasone in Patients with Unresectable Intrahepatic Cholangiocarcinoma

This study has been transitioned to CTIS with ID 2024-518065-10-00 check the CTIS register for the current data. The aim of the study is to demonstrate that HAI P chemotherapy is an effective treatment for unresectable intrahepatic…