Tolerance of the LiverNCT01237002
Pringle Time Exceeding 120 Min in Liver Resection
An observational study of Tolerance of the Liver, run by University of Milan at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 29 to 85 years
- Conditions the study is for
- Tolerance of the Liver
- How many people
- 189 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2005to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients in whom total cumulative clamping time exceeded 60 minutes.
Who cannot join
- patients in whom total cumulative clamping time was less than 60 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tolerance of the Liver
- Keywords
- Liver ischemia; Pringle time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 117 patients with cumulative clamping time between 60 and 120 minutes | |
| Group 2 | 72 patients with cumulative clamping time longer than 120 minutes |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startJan 2005
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tolerance of the LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Investigators
- Guido Torzilli, MD, PhD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237002
- Sponsor's protocol ID
- Pringle 120 minutes
- Status last verified
- Oct 2010
- First submitted
- 8 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 10077049Elias 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.
PubMed 1998862Torzilli 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.
PubMed 21975322
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Intermittent Pringle Maneuver Cumulative Time Exceeding 120 Min in Liver Resection
- ClinicalTrials.gov ID
- NCT01237002
- Acronym / sponsor ID
- Pringle 120 minutes
- Conditions
- Tolerance of the Liver
- Keywords
- Liver ischemia; Pringle time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –117 patients with cumulative clamping time between 60 and 120 minutes |
| Group 2 | – | –72 patients with cumulative clamping time longer than 120 minutes |
Who may qualify
- Ages
- 29 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients in whom total cumulative clamping time exceeded 60 minutes.
Key exclusion criteria (1 listed)
- patients in whom total cumulative clamping time was less than 60 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
- Background: PubMed 10077049Belghiti 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.
- Background: PubMed 1998862Elias 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.
- Derived from this study: PubMed 21975322Torzilli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Torzilli, MD, PhD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tolerance of the Liver, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237002, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2010.