Liver NeoplasmAANCT01180088
Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy
A study testing RIGHT HEPATECTOMY WITH CLASSIC APPROACH in people with Liver Neoplasm, run by Azienda Ospedaliera Ordine Mauriziano di Torino at 1 site in Italy.
Trial summary
The aim of this study was to evaluated the advantages of routine application of the anterior approach in patients scheduled to right hepatectomy or extended right hepatectomy, without infiltration of segment 1, inferior vena cava or main bile duct. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Neoplasm
- What is being tested?
- RIGHT HEPATECTOMY WITH CLASSIC APPROACH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2010to Aug 2011
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients between 18 and 80 years
- patients scheduled to right hepatectomy or extended right hepatectomy
- the future remnant liver (FRL) ≥ 25% in patients with a normal liver or ≥ 30% in those with chronic liver disease
- indocyanine green retention rate (ICG) at 15 minutes ≤ 10% in cirrhotic patients
Who cannot join
- resection of S1
- resection of bile duct
- infiltration of inferior vena cava
- America Society of Anesthesiologists (ASA) grade IV
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale Mauriziano di Torino
Turin, 10100
Alessandro Ferrero, MD, 00390115082590, aferrero@mauriziano.it
Lorenzo Capussotti, MD
About this study
Official title: Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy: A Randomized Trial
The aim of this study was to evaluated the advantages of routine application of the anterior approach in patients scheduled to right hepatectomy or extended right hepatectomy, without infiltration of segment 1, inferior vena cava or main bile duct.
Read the detailed description
Mobilization of the liver during right hepatectomy with classic approach is performed before parenchymal transection. In this phase severe bleeding may occur due to laceration of the inferior vena cava (IVC) wall, rupture or ligation falling off the hepatic short vein (HSV) or bleeding from the right liver attachments. Besides, the twisting of the portal pedicle during mobilization can render the left hepatic lobe ischemic for transient interruption of the hepatopetal flow. These events are more frequent in case of large hepatic lesions (mainly HCC) that involves surrounding structures (such as diaphragm). Two of the most important factors that affect the postoperative course of patients undergoing liver resections are indeed intraoperative bleeding and postoperative liver dysfunction. For these reasons Lai et al proposed anterior approach as alternative to classic right hepatectomy. In this case liver mobilization is performed only at the end of parenchymal transection, when all vascular connections are already interrupted. Liu et al published the results of a retrospective study in which 54 patients with, right sided HCC greater than 5 cm underwent right hepatectomy using the anterior approach technique. The anterior approach group had significantly less intraoperative blood loss, less need of blood transfusion and a lower hospital mortality rate. The same group reported results of a prospective randomized controlled study analyzing 120 patients with large (>5 cm) right liver HCC. The overall operative blood loss, morbidity, and duration of hospital stay were comparable in both groups. However, a higher number of patients in classic approach group experienced mayor operative blood loss (> 2000 cc) and required blood transfusions (8.3% vs. 28.3%).
- Conditions
- Liver Neoplasm
- Being tested
- RIGHT HEPATECTOMY WITH CLASSIC APPROACH
- Keywords
- LIVER TUMOURS
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIGHT HEPATECTOMY WITH CLASSIC APPROACHProcedure or surgery
Also called Right Hepatectomy
The right portal branch and the right branch of the hepatic artery were identified, dissected and divided. Extraparenchymal ligation of pedicles for Sg4 was performed in case of extended right hepatectomy. The falciform and the right triangular ligaments were sectioned and the right liver up to the retrohepatic vena cava was totally mobilized by section and sutures of the accessory right hepatic veins. The right hepatic vein was controlled in an extrahepatic plane and encircled with a tape. At the end of parenchymal transection right hepatic vein was sectioned with endovascular stapler. The right bile duct and middle hepatic vein (in case of extended right hepatectomy) were divided intraparenchymally
| Study group | Role | What they receive |
|---|---|---|
| ANTERIOR APPROACH | Experimental | SURGICAL TECHNIQUE Receives: Procedure: RIGHT HEPATECTOMY WITH CLASSIC APPROACH |
What is being measured
The primary outcome is the main question the study is designed to answer.
OVERALL BLOOD LOSS
Measured: UP TO 7 DAYS
Secondary outcomes (1)
BLOOD TRANSFUSION RATE
Measured: WITHIN 24 HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2010 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di Torino
- Sponsor type
- University, hospital or other
- Investigators
- Lorenzo Capussotti, MD, Principal investigator, Ospedale Mauriziano di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180088
- Sponsor's protocol ID
- AA001
- Acronym
- AA
- Status last verified
- Aug 2010
- First submitted
- 9 Aug 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Lai EC, Fan ST, Lo CM, Chu KM, Liu CL. Anterior approach for difficult major right hepatectomy. World J Surg. 1996 Mar-Apr;20(3):314-7; discussion 318. doi: 10.1007/s002689900050.
PubMed 8661837Liu CL, Fan ST, Cheung ST, Lo CM, Ng IO, Wong J. Anterior approach versus conventional approach right hepatic resection for large hepatocellular carcinoma: a prospective randomized controlled study. Ann Surg. 2006 Aug;244(2):194-203. doi: 10.1097/01.sla.0000225095.18754.45.
PubMed 16858181Liu CL, Fan ST, Lo CM, Tung-Ping Poon R, Wong J. Anterior approach for major right hepatic resection for large hepatocellular carcinoma. Ann Surg. 2000 Jul;232(1):25-31. doi: 10.1097/00000658-200007000-00004.
PubMed 10862191Capussotti L, Ferrero A, Russolillo N, Langella S, Lo Tesoriere R, Vigano L. Routine anterior approach during right hepatectomy: results of a prospective randomised controlled trial. J Gastrointest Surg. 2012 Jul;16(7):1324-32. doi: 10.1007/s11605-012-1894-6. Epub 2012 May 9.
PubMed 22570073
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01180088
- Acronym / sponsor ID
- AA / AA001
- Conditions
- Liver Neoplasm
- Keywords
- LIVER TUMOURS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di TorinoUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 11 Aug 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.
The aim of this study was to evaluated the advantages of routine application of the anterior approach in patients scheduled to right hepatectomy or extended right hepatectomy, without infiltration of segment 1, inferior vena cava or main bile duct.
Detailed description
Mobilization of the liver during right hepatectomy with classic approach is performed before parenchymal transection. In this phase severe bleeding may occur due to laceration of the inferior vena cava (IVC) wall, rupture or ligation falling off the hepatic short vein (HSV) or bleeding from the right liver attachments. Besides, the twisting of the portal pedicle during mobilization can render the left hepatic lobe ischemic for transient interruption of the hepatopetal flow. These events are more frequent in case of large hepatic lesions (mainly HCC) that involves surrounding structures (such as diaphragm). Two of the most important factors that affect the postoperative course of patients undergoing liver resections are indeed intraoperative bleeding and postoperative liver dysfunction. For these reasons Lai et al proposed anterior approach as alternative to classic right hepatectomy. In this case liver mobilization is performed only at the end of parenchymal transection, when all vascular connections are already interrupted. Liu et al published the results of a retrospective study in which 54 patients with, right sided HCC greater than 5 cm underwent right hepatectomy using the anterior approach technique. The anterior approach group had significantly less intraoperative blood loss, less need of blood transfusion and a lower hospital mortality rate. The same group reported results of a prospective randomized controlled study analyzing 120 patients with large (>5 cm) right liver HCC. The overall operative blood loss, morbidity, and duration of hospital stay were comparable in both groups. However, a higher number of patients in classic approach group experienced mayor operative blood loss (> 2000 cc) and required blood transfusions (8.3% vs. 28.3%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANTERIOR APPROACH | Experimental | Procedure: RIGHT HEPATECTOMY WITH CLASSIC APPROACHSURGICAL TECHNIQUE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients between 18 and 80 years
- patients scheduled to right hepatectomy or extended right hepatectomy
- the future remnant liver (FRL) ≥ 25% in patients with a normal liver or ≥ 30% in those with chronic liver disease
- indocyanine green retention rate (ICG) at 15 minutes ≤ 10% in cirrhotic patients
Key exclusion criteria (5 listed)
- resection of S1
- resection of bile duct
- infiltration of inferior vena cava
- America Society of Anesthesiologists (ASA) grade IV
- Emergency surgery
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 |
|---|---|---|
| RIGHT HEPATECTOMY WITH CLASSIC APPROACHAlso: Right HepatectomyThe right portal branch and the right branch of the hepatic artery were identified, dissected and divided. Extraparenchymal ligation of pedicles for Sg4 was performed in case of extended right hepatectomy. The falciform and the right triangular ligaments were sectioned and the right liver up to the retrohepatic vena cava was totally mobilized by section and sutures of the accessory right hepatic veins. The right hepatic vein was controlled in an extrahepatic plane and encircled with a tape. At the end of parenchymal transection right hepatic vein was sectioned with endovascular stapler. The right bile duct and middle hepatic vein (in case of extended right hepatectomy) were divided intraparenchymally | Procedure or surgery | ANTERIOR APPROACH |
Primary outcome
OVERALL BLOOD LOSS
Time frame: UP TO 7 DAYS
1 secondary outcome
BLOOD TRANSFUSION RATE
Time frame: WITHIN 24 HOURS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
- Background: PubMed 8661837Lai EC, Fan ST, Lo CM, Chu KM, Liu CL. Anterior approach for difficult major right hepatectomy. World J Surg. 1996 Mar-Apr;20(3):314-7; discussion 318. doi: 10.1007/s002689900050.
- Background: PubMed 16858181Liu CL, Fan ST, Cheung ST, Lo CM, Ng IO, Wong J. Anterior approach versus conventional approach right hepatic resection for large hepatocellular carcinoma: a prospective randomized controlled study. Ann Surg. 2006 Aug;244(2):194-203. doi: 10.1097/01.sla.0000225095.18754.45.
- Background: PubMed 10862191Liu CL, Fan ST, Lo CM, Tung-Ping Poon R, Wong J. Anterior approach for major right hepatic resection for large hepatocellular carcinoma. Ann Surg. 2000 Jul;232(1):25-31. doi: 10.1097/00000658-200007000-00004.
- Derived from this study: PubMed 22570073Capussotti L, Ferrero A, Russolillo N, Langella S, Lo Tesoriere R, Vigano L. Routine anterior approach during right hepatectomy: results of a prospective randomised controlled trial. J Gastrointest Surg. 2012 Jul;16(7):1324-32. doi: 10.1007/s11605-012-1894-6. Epub 2012 May 9.
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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.
Lorenzo Capussotti, MD principal investigator
Ospedale Mauriziano di Torino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIGHT HEPATECTOMY WITH CLASSIC APPROACH in people with Liver Neoplasm, run by Azienda Ospedaliera Ordine Mauriziano di Torino 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OVERALL BLOOD LOSS (time frame: UP TO 7 DAYS). 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 NCT01180088, which also lists 4 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 11 Aug 2010.