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Ischemic Preconditioning in Major Hepatectomy (HECLA)

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ClinicalTrials.gov Identifier: NCT00908245
Recruitment Status : Completed
First Posted : May 25, 2009
Last Update Posted : December 16, 2011
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

To evaluate the accuracy of ischemic preconditioning (IPC) as a protective maneuver against ischemia/reperfusion lesion in patients undergoing major liver resection with intermittent portal triad Clamping (IPTC).

Summary Background Data: For sake of safety and to avoid excessive blood loss during parenchymal transection, vascular inflow occlusion is an effective trick but may cause ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver disease. IPTC has been proven to be superior to continuous hepatic pedicle clamping as it preserve liver remnant from severe ischemia/reperfusion lesion, so does IPC. Yet, if IPC is beneficial if liver resection is performed under IPTC has never been demonstrated in a randomised controlled trial (RCT). The investigators designed a RCT to assess the impact of IPC in patient undergoing major liver resection with intermittent vascular inflow occlusion.


Condition or disease Intervention/treatment Phase
Ischaemic Type Biliary Lesion Procedure: Control Procedure: Preconditioning ischemia Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Ischemic Preconditioning in Patients Undergoing Major Liver Resection With Intermittent Pedicular Clamping: A Multicentric Randomized Trial
Study Start Date : September 2003
Actual Primary Completion Date : June 2007
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: Preconditioning
Surgery with ischemic preconditioning
Procedure: Preconditioning ischemia
Surgery with a preconditioning ischemia
Other Name: Surgery with a preconditioning ischemia

Active Comparator: Control
Surgery without preconditioning ischemia
Procedure: Control
Surgery without preconditioning surgery
Other Name: Surgery without preconditioning surgery




Primary Outcome Measures :
  1. The primary outcome was a 50% reduction of transaminases (AST, ALT) level on postoperative day 1 in the preconditioning group. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Surgical mortality during the postoperative 3 months [ Time Frame: 3 months ]
  2. Surgical and medical morbidity during the postoperative 3 months [ Time Frame: 3 months ]
  3. Biological follow up during 3 months [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients' age ≥ 18 years old,
  • liver resection of 3 segments (as described by Couinaud) or more,
  • posterior lesionectomy (segment VI and VII),
  • liver resection only or associated with a primary digestive or biliary tumor.
  • Portal vein embolisation allowed

Exclusion Criteria:

  • Patients with cirrhosis,
  • synchronous radiofrequency or cryotherapy ablation,
  • undergoing segmentectomy,
  • left lateral lesionectomy or laparoscopic liver resection,
  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908245


Locations
France
Hopital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Olivier Scatton, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00908245     History of Changes
Other Study ID Numbers: AOR01010
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: July 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Preconditioning
Hepatectomy
Clamping

Additional relevant MeSH terms:
Ischemia
Pathologic Processes