Surgical Blood LossNCT02996006
New Techniques to Reduce Intra-operative Bleeding During Complex Liver Resection
An observational study of Surgical Blood Loss, run by Tongji Hospital.
Trial summary
This observational study introduced an new advanced bleeding control strategy during complex liver resection.This newly described "stepwise vascular control" technique was efficacious and feasible to control intra-operative bleeding in complex hepatectomy involving second hepatic hilum and retro-hepatic inferior vena… Read more about this study
- Who is it for?
- Ages 41 to 68 years
- Conditions the study is for
- Surgical Blood Loss
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Jul 2016
- How long will I take part?
- 3 Months
- 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 41 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patient sampling according to the eligibility criteria
Who may be able to join
- tumor size is more than 5cm in diameter;
- these tumor were close to or were compressing main hepatic veins and RIVC directly;
- Pugh-Child Grade is A or Indocyanine green retention rate at 15min (ICG15%) is less than 10% .
Who cannot join
None listed.
About this study
This observational study introduced an new advanced bleeding control strategy during complex liver resection.This newly described "stepwise vascular control" technique was efficacious and feasible to control intra-operative bleeding in complex hepatectomy involving second hepatic hilum and retro-hepatic inferior vena cava.
- Conditions
- Surgical Blood Loss
- Being tested
- stepwise vascular control
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stepwise vascular controlProcedure or surgery
Before liver parenchymal resection, we performed "total hepatic vascular preparation for occlusion" with portal triad (PT), infra-hepatic inferior vena cava (IIVC), and supra-hepatic inferior vena cava (SIVC) preparation in order. Then we performed step-by-step vascular occlusion according to the individual bleeding situation.
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss during liver resection
Measured: duration of operation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startNov 2009
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Blood LossStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Dou, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996006
- Sponsor's protocol ID
- TJ-liver-200804
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
Publications
Dou L, Yu ZP, Yang HY, Ran J, Chen YF, Chen XP. Personalized stepwise vascular control during complex hepatectomy involving hepatocaval confluence. ANZ J Surg. 2018 Jul-Aug;88(7-8):E606-E609. doi: 10.1111/ans.14301. Epub 2017 Dec 10.
PubMed 29224239
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Techniques to Reduce Intra-operative Bleeding During Complex Liver Resection
- ClinicalTrials.gov ID
- NCT02996006
- Acronym / sponsor ID
- TJ-liver-200804
- Conditions
- Surgical Blood Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2016 (actual)
- First posted
- 19 Dec 2016 (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.
This observational study introduced an new advanced bleeding control strategy during complex liver resection.This newly described "stepwise vascular control" technique was efficacious and feasible to control intra-operative bleeding in complex hepatectomy involving second hepatic hilum and retro-hepatic inferior vena cava.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 41 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patient sampling according to the eligibility criteria
Key inclusion criteria (3 listed)
- tumor size is more than 5cm in diameter;
- these tumor were close to or were compressing main hepatic veins and RIVC directly;
- Pugh-Child Grade is A or Indocyanine green retention rate at 15min (ICG15%) is less than 10% .
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stepwise vascular controlBefore liver parenchymal resection, we performed "total hepatic vascular preparation for occlusion" with portal triad (PT), infra-hepatic inferior vena cava (IIVC), and supra-hepatic inferior vena cava (SIVC) preparation in order. Then we performed step-by-step vascular occlusion according to the individual bleeding situation. | Procedure or surgery | – |
Primary outcome
blood loss during liver resection
Time frame: duration of operation time
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 19 Dec 2016.
- Derived from this study: PubMed 29224239Dou L, Yu ZP, Yang HY, Ran J, Chen YF, Chen XP. Personalized stepwise vascular control during complex hepatectomy involving hepatocaval confluence. ANZ J Surg. 2018 Jul-Aug;88(7-8):E606-E609. doi: 10.1111/ans.14301. Epub 2017 Dec 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Blood Loss, run by Tongji Hospital.
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 3 inclusion and 0 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 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
blood loss during liver resection (time frame: duration of operation time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02996006, which also lists 1 linked publication.
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 19 Dec 2016.