Liver TumorsNCT00960609
Communicating Veins Between Adjacent Hepatic Veins: an Intra-operative Ultrasound Study
An observational study of Liver Tumors, run by University of Milan at 1 site in Italy.
Trial summary
The search for communicating veins (CVs) between adjacent hepatic veins (HVs) has drawn its rationale from living donor liver transplantation (LDLT). Parenchymal sparing procedures although HVs are resected suggest that probably their presence is underestimated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Tumors
- What is being tested?
- Ultrasound guided liver resection
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jan 2008to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with primary and metastatic liver tumors addressed to surgical treatment
Who may be able to join
- Patients suitable for being enrolled in the present study were those carriers of primary or metastatic tumour with direct contact or invasion of one HV at the caval confluence.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Communicating Veins Between Adjacent Hepatic Veins: Rare, Exceptional or Frequent? An Intra-operative Ultrasound Study
The search for communicating veins (CVs) between adjacent hepatic veins (HVs) has drawn its rationale from living donor liver transplantation (LDLT). Parenchymal sparing procedures although HVs are resected suggest that probably their presence is underestimated.
Taking profit from new improvements in ultrasound technology the investigators aim to better estimate the rate of CVs in a consecutive series of patients in whom resection of one HV at caval confluence is needed.
Read the detailed description
The search for communicating veins (CVs) between adjacent hepatic veins (HVs) has drawn its rationale from the need of reducing the risk of incomplete blood outflow in the medial portion of the hemiliver without the middle hepatic vein (MHV) in living donor liver transplantation (LDLT). However, only 24% of patients seems having CVs based on the findings of color-Doppler intraoperative ultrasound (CD-IOUS) exploration. On the other hand the safety of parenchymal sparing procedure despite HV resection let suppose that CVs are probably more frequent than expected.
Certainly, better in vivo knowledge of the rate of CVs and their direct detection would consolidate and probably further expand parenchymal sparing techniques. Taking profit from new advancements in ultrasound technology we have carried out the present study with the aim of better estimating the rate of CVs in a consecutive series of patients in whom resection of one HV at caval confluence was needed.
- Conditions
- Liver Tumors
- Being tested
- Ultrasound guided liver resection
- Keywords
- Communicating veins, hepatic venous anastomosis, intra-operative ultrasonography, hepatic resection, hepatic neoplasm, Primary and metastatic liver tumors
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided liver resectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| caval confluence HV involvement | Patients carriers of primary or metastatic tumour with direct contact or invasion of one HV at the caval confluence. Receives: Procedure: Ultrasound guided liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
First outcome was the rate of CVs detectable with e-flow IOUS along clamping of the HV for which resection could be needed.
Secondary outcomes (1)
Secondary outcome was safety (morbidity, mortality, blood loss, blood transfusions) of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver TumorsStudies 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
- Prospective
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960609
- Sponsor's protocol ID
- CV-HV
- Status last verified
- Aug 2009
- First submitted
- 17 Aug 2009
- Last updated
- 18 Aug 2009
- Results posted
- No
Publications
Torzilli G, Procopio F, Botea F, Marconi M, Del Fabbro D, Donadon M, Palmisano A, Spinelli A, Montorsi M. One-stage ultrasonographically guided hepatectomy for multiple bilobar colorectal metastases: a feasible and effective alternative to the 2-stage approach. Surgery. 2009 Jul;146(1):60-71. doi: 10.1016/j.surg.2009.02.017.
PubMed 19541011Torzilli G, Donadon M, Marconi M, Palmisano A, Del Fabbro D, Spinelli A, Botea F, Montorsi M. Hepatectomy for stage B and stage C hepatocellular carcinoma in the Barcelona Clinic Liver Cancer classification: results of a prospective analysis. Arch Surg. 2008 Nov;143(11):1082-90. doi: 10.1001/archsurg.143.11.1082.
PubMed 19015467Torzilli G, Donadon M, Marconi M, Botea F, Palmisano A, Del Fabbro D, Procopio F, Montorsi M. Systematic extended right posterior sectionectomy: a safe and effective alternative to right hepatectomy. Ann Surg. 2008 Apr;247(4):603-11. doi: 10.1097/SLA.0b013e31816387d7.
PubMed 18362622Torzilli G, Donadon M, Palmisano A, Del Fabbro D, Spinelli A, Makuuchi M, Montorsi M. Back-flow bleeding control during resection of right-sided liver tumors by means of ultrasound-guided finger compression of the right hepatic vein at its caval confluence. Hepatogastroenterology. 2007 Jul-Aug;54(77):1364-7.
PubMed 17708255Torzilli G, Montorsi M, Del Fabbro D, Palmisano A, Donadon M, Makuuchi M. Ultrasonographically guided surgical approach to liver tumours involving the hepatic veins close to the caval confluence. Br J Surg. 2006 Oct;93(10):1238-46. doi: 10.1002/bjs.5321.
PubMed 16953487Sano K, Makuuchi M, Miki K, Maema A, Sugawara Y, Imamura H, Matsunami H, Takayama T. Evaluation of hepatic venous congestion: proposed indication criteria for hepatic vein reconstruction. Ann Surg. 2002 Aug;236(2):241-7. doi: 10.1097/00000658-200208000-00013.
PubMed 12170030
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating Veins Between Adjacent Hepatic Veins: Rare, Exceptional or Frequent? An Intra-operative Ultrasound Study
- ClinicalTrials.gov ID
- NCT00960609
- Acronym / sponsor ID
- CV-HV
- Conditions
- Liver Tumors
- Keywords
- Communicating veins, hepatic venous anastomosis, intra-operative ultrasonography, hepatic resection, hepatic neoplasm, Primary and metastatic liver tumors
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2008
- First posted
- 18 Aug 2009 (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.
The search for communicating veins (CVs) between adjacent hepatic veins (HVs) has drawn its rationale from living donor liver transplantation (LDLT). Parenchymal sparing procedures although HVs are resected suggest that probably their presence is underestimated.
Taking profit from new improvements in ultrasound technology the investigators aim to better estimate the rate of CVs in a consecutive series of patients in whom resection of one HV at caval confluence is needed.
Detailed description
The search for communicating veins (CVs) between adjacent hepatic veins (HVs) has drawn its rationale from the need of reducing the risk of incomplete blood outflow in the medial portion of the hemiliver without the middle hepatic vein (MHV) in living donor liver transplantation (LDLT). However, only 24% of patients seems having CVs based on the findings of color-Doppler intraoperative ultrasound (CD-IOUS) exploration. On the other hand the safety of parenchymal sparing procedure despite HV resection let suppose that CVs are probably more frequent than expected.
Certainly, better in vivo knowledge of the rate of CVs and their direct detection would consolidate and probably further expand parenchymal sparing techniques. Taking profit from new advancements in ultrasound technology we have carried out the present study with the aim of better estimating the rate of CVs in a consecutive series of patients in whom resection of one HV at caval confluence was needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| caval confluence HV involvement | – | Procedure: Ultrasound guided liver resectionPatients carriers of primary or metastatic tumour with direct contact or invasion of one HV at the caval confluence. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary and metastatic liver tumors addressed to surgical treatment
Key inclusion criteria (1 listed)
- Patients suitable for being enrolled in the present study were those carriers of primary or metastatic tumour with direct contact or invasion of one HV at the caval confluence.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Ultrasound guided liver resection | Procedure or surgery | caval confluence HV involvement |
Primary outcome
First outcome was the rate of CVs detectable with e-flow IOUS along clamping of the HV for which resection could be needed.
1 secondary outcome
Secondary outcome was safety (morbidity, mortality, blood loss, blood transfusions) of the procedure.
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 18 Aug 2009.
- Background: PubMed 19541011Torzilli G, Procopio F, Botea F, Marconi M, Del Fabbro D, Donadon M, Palmisano A, Spinelli A, Montorsi M. One-stage ultrasonographically guided hepatectomy for multiple bilobar colorectal metastases: a feasible and effective alternative to the 2-stage approach. Surgery. 2009 Jul;146(1):60-71. doi: 10.1016/j.surg.2009.02.017.
- Background: PubMed 19015467Torzilli G, Donadon M, Marconi M, Palmisano A, Del Fabbro D, Spinelli A, Botea F, Montorsi M. Hepatectomy for stage B and stage C hepatocellular carcinoma in the Barcelona Clinic Liver Cancer classification: results of a prospective analysis. Arch Surg. 2008 Nov;143(11):1082-90. doi: 10.1001/archsurg.143.11.1082.
- Background: PubMed 18362622Torzilli G, Donadon M, Marconi M, Botea F, Palmisano A, Del Fabbro D, Procopio F, Montorsi M. Systematic extended right posterior sectionectomy: a safe and effective alternative to right hepatectomy. Ann Surg. 2008 Apr;247(4):603-11. doi: 10.1097/SLA.0b013e31816387d7.
- Background: PubMed 17708255Torzilli G, Donadon M, Palmisano A, Del Fabbro D, Spinelli A, Makuuchi M, Montorsi M. Back-flow bleeding control during resection of right-sided liver tumors by means of ultrasound-guided finger compression of the right hepatic vein at its caval confluence. Hepatogastroenterology. 2007 Jul-Aug;54(77):1364-7.
- Background: PubMed 16953487Torzilli G, Montorsi M, Del Fabbro D, Palmisano A, Donadon M, Makuuchi M. Ultrasonographically guided surgical approach to liver tumours involving the hepatic veins close to the caval confluence. Br J Surg. 2006 Oct;93(10):1238-46. doi: 10.1002/bjs.5321.
- Background: PubMed 12170030Sano K, Makuuchi M, Miki K, Maema A, Sugawara Y, Imamura H, Matsunami H, Takayama T. Evaluation of hepatic venous congestion: proposed indication criteria for hepatic vein reconstruction. Ann Surg. 2002 Aug;236(2):241-7. doi: 10.1097/00000658-200208000-00013.
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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.
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 Liver Tumors, 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 18 Aug 2009. 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.
What does the primary outcome measure?
First outcome was the rate of CVs detectable with e-flow IOUS along clamping of the HV for which resection could be needed.. 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 NCT00960609, which also lists 6 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 18 Aug 2009.