Portal Hypertension and Liver Resection in Patients With... | NCT02145013

Studies
Portal Hypertension and Liver Resection in Patients With Hepatocellular Carcinoma

NCT02145013

Sponsor

Henri Mondor University Hospital

Status

Unknown status

Last Update Posted

Feb 12, 2018Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Primary Liver Cancers

Interventions

Liver resection

Countries

France

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Dec 2017Actual

Completion Date

May 30, 2018Estimated

First Submitted Date

May 20, 2014

First Submission Date that Met QC Criteria

May 20, 2014

First Posted Date

May 22, 2014Estimated

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

Feb 8, 2018

Last Update Posted Date

Feb 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

According to the BCLC guidelines, surgical resection of hepatocellular carcinoma complicating cirrhosis is restricted to patients with preserved liver function, single nodule without vascular invasion and with hepatic venous gradient below 10 mmHg.

However, other guideline treatment, especially from eastern countries demonstrated that surgical resection is safe and feasible and provides better survival than the treatment recommended by the BCLC system for patients with similar stage.

The primary goal of this study is to assess the impact of HVPG on short and long-term outcomes in HCC patients who undergo liver resection.

Detailed Description

Patients with HCC and candidates for hepatectomy are classified into two groups according to the presence of portal hypertension. Short- and long-term outcomes will be compared.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Portal hypertension		Hepatectomy	Procedure: Liver resection
No portal hypertension		Hepatectomy	Procedure: Liver resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liver resection	Procedure	Hepatectomy by either open, laparoscopic or robotic procedures	No portal hypertension Portal hypertension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	In-hospital or 90-day mortality	90 day

Secondary Outcomes

Measure	Description	Time Frame
morbidity	Overall and liver-related complications including liver failure, ascites, biliary fistula, bleeding, pulmonary complications, and renal complications. Grading system according to Clavien-Dindo classification	90 day
Survival outcomes

Other Outcomes

Measure	Description	Time Frame
Acute kidney injury	As defined by the KDIGIO criteria	within 90 days after surgery
Sarcopenia	using computed tomography	Before liver resection

Eligibility Module

Eligibility Criteria

Patients with hepatocellular carcinoma who undergo surgical resection (intention to treat analysis)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with hepatocellular carcinoma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Azoulay, MD PhD	Henri Mondor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henri Mondor University Hospital		Créteil		94000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18549877	Background	Ishizawa T, Hasegawa K, Aoki T, Takahashi M, Inoue Y, Sano K, Imamura H, Sugawara Y, Kokudo N, Makuuchi M. Neither multiple tumors nor portal hypertension are surgical contraindications for hepatocellular carcinoma. Gastroenterology. 2008 Jun;134(7):1908-16. doi: 10.1053/j.gastro.2008.02.091. Epub 2008 Mar 8.
30401520	Derived

ID	Term
D006975	Hypertension, Portal
D006528	Carcinoma, Hepatocellular

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D000230	Adenocarcinoma
D002277	Carcinoma

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative