Ischemic Preconditioning in Major Hepatectomy

NCT00908245 | Completed Phase 3

• 1 other identifier: AOR01010
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischaemic Type Biliary Lesion

Keywords

Preconditioning; Hepatectomy; Clamping

Outcome Measures

Primary Outcomes (1)

• The primary outcome was a 50% reduction of transaminases (AST, ALT) level on postoperative day 1 in the preconditioning group.

  24 hours

Secondary Outcomes (3)

• Surgical mortality during the postoperative 3 months

  3 months

• Surgical and medical morbidity during the postoperative 3 months

  3 months

• Biological follow up during 3 months

  3 months

Study Arms (2)

Preconditioning

EXPERIMENTAL

Surgery with ischemic preconditioning

Procedure: Preconditioning ischemia

Control

ACTIVE COMPARATOR

Surgery without preconditioning ischemia

Procedure: Control

Interventions

Control PROCEDURE

Surgery without preconditioning surgery

Also known as: Surgery without preconditioning surgery

Control

Preconditioning ischemia PROCEDURE

Surgery with a preconditioning ischemia

Also known as: Surgery with a preconditioning ischemia

Preconditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hopital Cochin

Paris, 75014, France

Location

Related Publications (1)

• Scatton O, Zalinski S, Jegou D, Compagnon P, Lesurtel M, Belghiti J, Boudjema K, Lentschener C, Soubrane O. Randomized clinical trial of ischaemic preconditioning in major liver resection with intermittent Pringle manoeuvre. Br J Surg. 2011 Sep;98(9):1236-43. doi: 10.1002/bjs.7626. Epub 2011 Jul 11.

  PMID: 21809337 RESULT

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Olivier Scatton, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 25, 2009
• Study Start: September 1, 2003
• Primary Completion: June 1, 2007
• Study Completion: December 1, 2008
• Last Updated: November 20, 2025

Record last verified: 2025-09

Locations

FR (1)