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Ischemic Preconditioning in Major Hepatectomy (HECLA)

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: May 22, 2009
Last updated: December 15, 2011
Last verified: July 2011

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 Intervention Phase
Ischaemic Type Biliary Lesion
Procedure: Control
Procedure: Preconditioning ischemia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Ischemic Preconditioning in Patients Undergoing Major Liver Resection With Intermittent Pedicular Clamping: A Multicentric Randomized Trial

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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:
  • Surgical mortality during the postoperative 3 months [ Time Frame: 3 months ]
  • Surgical and medical morbidity during the postoperative 3 months [ Time Frame: 3 months ]
  • Biological follow up during 3 months [ Time Frame: 3 months ]

Enrollment: 81
Study Start Date: September 2003
Study Completion Date: December 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00908245

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00908245     History of Changes
Other Study ID Numbers: AOR01010
Study First Received: May 22, 2009
Last Updated: December 15, 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Additional relevant MeSH terms:
Pathologic Processes processed this record on May 25, 2017