- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237002
Pringle Time Exceeding 120 Min in Liver Resection
November 8, 2010 updated by: University of Milan
Safety of Intermittent Pringle Maneuver Cumulative Time Exceeding 120 Min in Liver Resection
Intermittent Pringle's maneuver is widely used to limit blood loss during hepatectomy, without an established time-limit.
However, many authors claims its danger for patients' outcome.
The investigators check the short term outcome of a consecutive cohort of patients who underwent hepatectomy with intermittent clamping exceeding 120 minutes.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
189
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Milan
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Rozzano, Milan, Italy, 20089
- IRCCS Istituto Clinico Humanitas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
29 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Among 426 consecutive patients who underwent hepatectomy, we retrospectively selected 189 patients with clamping time exceeded 60 minutes: 117 having intermittent Pringle maneuver less 120 minutes and 72 having clamping time exceeding 120 minutes were analysed.
Description
Inclusion Criteria:
- patients in whom total cumulative clamping time exceeded 60 minutes.
Exclusion Criteria:
- patients in whom total cumulative clamping time was less than 60 minutes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Group 1
117 patients with cumulative clamping time between 60 and 120 minutes
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Group 2
72 patients with cumulative clamping time longer than 120 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guido Torzilli, MD, PhD, IRCCS Istituto Clinico Humanitas
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Belghiti J, Noun R, Malafosse R, Jagot P, Sauvanet A, Pierangeli F, Marty J, Farges O. Continuous versus intermittent portal triad clamping for liver resection: a controlled study. Ann Surg. 1999 Mar;229(3):369-75. doi: 10.1097/00000658-199903000-00010.
- Elias D, Desruennes E, Lasser P. Prolonged intermittent clamping of the portal triad during hepatectomy. Br J Surg. 1991 Jan;78(1):42-4. doi: 10.1002/bjs.1800780115.
- Torzilli G, Procopio F, Donadon M, Del Fabbro D, Cimino M, Montorsi M. Safety of intermittent Pringle maneuver cumulative time exceeding 120 minutes in liver resection: a further step in favor of the "radical but conservative" policy. Ann Surg. 2012 Feb;255(2):270-80. doi: 10.1097/SLA.0b013e318232b375.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
November 8, 2010
First Submitted That Met QC Criteria
November 8, 2010
First Posted (Estimate)
November 9, 2010
Study Record Updates
Last Update Posted (Estimate)
November 9, 2010
Last Update Submitted That Met QC Criteria
November 8, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pringle 120 minutes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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