Hepatic and Portal Vein Transection by Vascular Stapler i... | NCT06910852

Studies
Hepatic and Portal Vein Transection by Vascular Stapler in Open Living Donor Hepatectomy

NCT06910852

Sponsor

Abdalla Bashir, MD

Status

Completed

Last Update Posted

Apr 4, 2025Actual

Enrollment

17Actual

Phase

Not provided

Conditions

Hepatectomy

Interventions

Vascular stapler

Countries

Jordan

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

Mar 2025

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

Jun 18, 2021Actual

Primary Completion Date

Nov 30, 2021Actual

Completion Date

Nov 30, 2021Actual

First Submitted Date

Mar 28, 2025

First Submission Date that Met QC Criteria

Mar 28, 2025

First Posted Date

Apr 4, 2025Actual

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

Mar 28, 2025

Last Update Posted Date

Apr 4, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To enhance donor safety in living donor liver transplantation (LDLT), the use of vascular staplers for the division of the right portal and hepatic veins in patients undergoing right lobe liver donation has been introduced. This study examines the application of vascular staplers in LDLT and assesses the subsequent feasibility and safety outcomes for donors.

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

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

17Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vascular stapler	Procedure	the utilization of vascular staplers for the division of the right portal and hepatic veins in patients undergoing right lobe liver donation for living donor liver transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative complications (Clavien-Dindo classification)		From enrollment to the end of treatment at 6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing open living donor hepatectomy
Age ≥ 18 years, ≤ 80 years
Written informed consent

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing open living donor hepatectomy at Jordan Hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jordan Hospital Amman		Amman	Amman Governorate	11152	Jordan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided