Long-term Management of Patients With Ruptured HCC | NCT06505291

Studies
Long-term Management of Patients With Ruptured HCC

NCT06505291

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

Jul 17, 2024Actual

Enrollment

112Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

Not provided

Countries

Not provided

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2008Actual

Primary Completion Date

Sep 1, 2023Actual

Completion Date

Apr 30, 2024Actual

First Submitted Date

Jun 25, 2024

First Submission Date that Met QC Criteria

Jul 10, 2024

First Posted Date

Jul 17, 2024Actual

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

Jul 10, 2024

Last Update Posted Date

Jul 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 main objective of this work is to evaluate the prevalence and results of specific management of HCC after spontaneous rupture, since the arrival of sorafenib in 2008.

Detailed Description

Retrospective, observational, multicenter study over the period from January 2008 to April 2024.

Cases had to be 18 years or older. They were identified by two different methodologies adapted to the 4 participating centers. In particular, a request for ICD10 C22.0 (CHC) codes associated with K66.1 (hemoperitoneum) was carried out by the medical information departments (DIM) of the Caen University Hospital and the Avicenne hospital. Secondly, the automated keyword selection tools "Cohort 360" and "i2b2" were used at the La Pitié Salpetrière and Paul Brousse hospital centers to identify the terms "CHC" and "ruptured" in the computerized patient files. Secondarily, duplicates and coding errors were excluded.

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

16 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival after rupture of hepatocellular carcinoma		15 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ruptured hepatocellular carcinoma with or without cirrhosis

Exclusion Criteria:

Liver adenoma without histologically proven HCC
Other benign or malignant liver tumors
ATCD of potentially triggering interventional procedure in the previous month.
Hemorrhagic ascites without tumor
Intratumoral hemorrhages without hemoperitoneum or capsular rupture

Accepts Healthy Volunteers

Yes

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

Patient with ruptured hepatocellular carcinoma

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40990229	Derived	Commin A, Metivier C, Allaire M, Lubrano J, Claudinot A, Coilly A, Allard MA, Roux C, Scatton O, Nault JC, Sutter O, Ganne-Carrie N, Ngo TV, Goff VL, Ali ZB, Tedlaouti H, Papin J, Habireche M, Lebedel L, Perignon C, Dao T, Morello R, Ollivier-Hourmand I. Early Hemostatic Treatment Could Improve 30-Day Survival After Spontaneous Rupture of Hepatocellular Carcinoma. Liver Int. 2025 Oct;45(10):e70332. doi: 10.1111/liv.70332.

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