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Ischemic Preconditioning in Major Hepatectomy (HECLA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00908245
First received: May 22, 2009
Last updated: December 15, 2011
Last verified: July 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgical mortality during the postoperative 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Surgical and medical morbidity during the postoperative 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Biological follow up during 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908245

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

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional 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
Study First Received: May 22, 2009
Last Updated: December 15, 2011
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013