NCT01432548

Brief Summary

Vascular occlusion is used to reduce blood loss during liver resection (LR), but may cause ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver disease. This restriction of blood flow (ischemia) and subsequent restoration (reperfusion) causes a harm that is called ischemia- reperfusion injury. Injuries sustained during the ischemic phase are related to a lack of oxygen to reduce cellular respiratory events can lead to, in a few minutes, irreversible damage. Ischemic preconditioning as a technique to protect the liver parenchyma during liver resection consists of an initial flow clamping for 10 minutes, with subsequent reperfusion for 10-15min, followed by a complete portal triad clamping during transection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

September 13, 2011

Status Verified

September 1, 2011

Enrollment Period

1 year

First QC Date

August 29, 2011

Last Update Submit

September 12, 2011

Conditions

Ischemic Lesions

Keywords

Ischemicpreconditioningliverresection

Outcome Measures

Primary Outcomes (1)

  • Mortality Complications

    within 30 days after surgery

Secondary Outcomes (1)

  • Operative variables,markers of liver function and injury, pathological parenchymal characteristics

    within 30 days after surgey

Interventions

ischemic preconditioningPROCEDURE

Surgery with ischemic preconditioning in liver resection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients' age ≥ 18 years old
  • Portal vein embolization allowed

You may not qualify if:

  • laparoscopic liver resection
  • pregnant women
  • lack of patient consent
  • lack of acceptance of the operating surgeon
  • Hilar cholangiocarcinoma
  • Simultaneous hepaticojejunostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Dr Cosme Argerich

Buenos Aires, Buenos Aires, Argentina

RECRUITING

MeSH Terms

Conditions

Ischemia

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Central Study Contacts

Javier Lendoire, MD, PhD

CONTACT

5491160116898jlendoire@yahoo.com.ar

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ischemic preconditioning vs intermittent portal triad clamping in liver resection. Prospective Randomized Comparison

Study Record Dates

First Submitted

August 29, 2011

First Posted

September 13, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

October 1, 2012

Last Updated

September 13, 2011

Record last verified: 2011-09

Locations

AR(1)