Liver Embolization Approaches for Tumor Management | NCT05714124

Studies
Liver Embolization Approaches for Tumor Management

NCT05714124

Sponsor

IRCCS San Raffaele

Status

Recruiting

Last Update Posted

Apr 12, 2024Actual

Enrollment

580Estimated

Phase

Not provided

Conditions

Hepatocellular Carcinoma
Cholangiocarcinoma
Metastatic Colon Cancer
Metastatic Cancer
Metastatic Gastric Cancer
Primary Liver Cancer
Metastatic Pancreatic Cancer

Interventions

Embolization

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 21, 2021Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2031Estimated

First Submitted Date

Jan 25, 2023

First Submission Date that Met QC Criteria

Feb 3, 2023

First Posted Date

Feb 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2024

Last Update Posted Date

Apr 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this evaluate short, medium and long term outcome of the different embolization techniques in patients with primary and secondary hepatic tumors. The main aim is to evaluate progression free survival following embolization in this study population or evaluate residual hepatic volume in cases in which these techniques are used to induce liver regeneration. This study is an observational registry - all patients will follow their normal therapeutic and treatment scheme as per clinical practice, without any additional intervention.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

580Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Embolization	Procedure	Endovascular treatment for patients with primary and secondary liver tumors		Transarterial Chemoembolisation Transarterial Radioembolization Bland Transarterial Embolization Hepatic Vein Embollization Portal Vein Embolization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival	Treatment Efficacy	Short term (3-6 months)
Progression free survival		From time of intervention up to 1 year (medium term)
Progression free survival		From time of intervention up to 5 years (Long term)
Residual hepatic volume	Treatment Efficacy	within 40 days of procedure

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival	From date of procedure until the date of death from any cause, whichever came first, assessed up to 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 18 yoa
patients with patients with primary or secondary liver disease not amenable for surgery or ablation
patients with primary or secondary liver tumors candidates for major surgery prior to induction of hypertrophy
able and willing to sign informed consent

Exclusion Criteria:

pregnant women
patients with uncorrectable coagulopathy
diffuse extrahepatic disease
for lobar TACE and TARE - presence of bilodigestive shunt
for TARE - >20% hepatopulmonary shunt

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with primary or secondary liver tumors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francesco De Cobelli, MD	Contact	+39022643	2529	trialcliniciradiologia@hsr.it
Stephanie Steidler, PhD	Contact	+39022643	6111	steidler.stephanie@hsr.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Ospedale San Raffaele	Recruiting	Milan		20132	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D018281	Cholangiocarcinoma
D003110	Colonic Neoplasms
D009362	Neoplasm Metastasis
D013274	Stomach Neoplasms
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004621	Embolization, Therapeutic

Ancestor Terms

ID	Term
D006489	Hemostatic Techniques
D013812	Therapeutics
D060205	Therapeutic Occlusion

Browse Leaves

Not provided

Browse Branches

Not provided