Ischemic Preconditioning. Prospective Comparison (IP)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Hospital General de Agudos “Dr. Cosme Argerich”.
Recruitment status was: Recruiting
Information provided by (Responsible Party):
Juan Marcelo Rivaldi, Hospital General de Agudos "Dr. Cosme Argerich"
First received: August 29, 2011
Last updated: September 12, 2011
Last verified: September 2011
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.
Procedure: ischemic preconditioning
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
||Ischemic Preconditioning Versus Intermittent Portal Triad Clamping in Liver Resection. Prospective Randomized Comparison
Primary Outcome Measures:
- Mortality Complications [ Time Frame: within 30 days after surgery ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Operative variables,markers of liver function and injury, pathological parenchymal characteristics [ Time Frame: within 30 days after surgey ] [ Designated as safety issue: No ]
Operative time Transection time Operative blood loss Transection area Intraoperative haemodynamic and gases parameters (CVP, MAP) Requirement of blood products. ICU and total length of hospital stay Markers of liver function (Bilirrubin, prothtrombin time) Markers of liver injury (aspartate aminotransferase (AST), alanine aminotransferase (ALT) Pathological parenchymal characteristics
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2012 (Final data collection date for primary outcome measure)
This is a prospective controlled trial, conducted between July 2011 and July 2012. This study has been initiated by Liver & Transplant Division, Hospital Dr Cosme Argerich, Buenos Aires Argentina. The protocol was approved by ethics committees and an informed consent was obtained from each patient before they were enrolled. Sixty patients were randomized to either receive ischemic preconditioning prior to liver resection under intermittent pedicle clamping or Intermittent Pringle ischemia. Ischemic preconditioning was performed through a sequence of 10 minutes vascular inflow occlusion and 10 minutes of reperfusion prior to continuous pedicle clamping during resection. Intermittent pedicle clamping was conducted through a sequence of 15 minutes of vascular inflow occlusion and 5 minutes of reperfusion. The randomization process which was centralized was held in the operating room after inclusion criteria had been check and exclusion criteria ruled out.
|Ages Eligible for Study:
||18 Years to 90 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- patients' age ≥ 18 years old
- Portal vein embolization allowed
- laparoscopic liver resection
- pregnant women
- lack of patient consent
- lack of acceptance of the operating surgeon
- Hilar cholangiocarcinoma
- Simultaneous hepaticojejunostomy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01432548
|Hospital Dr Cosme Argerich
|Buenos Aires, Argentina |
Hospital General de Agudos “Dr. Cosme Argerich”
||Juan Marcelo Rivaldi, Ischemic preconditioning vs intermittent portal triad clamping in liver resection. Prospective Randomized Comparison, Hospital General de Agudos "Dr. Cosme Argerich"
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 29, 2011
||September 12, 2011
||Argentina: Ministry of Health
Keywords provided by Hospital General de Agudos “Dr. Cosme Argerich”:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2016