Liver NeoplasmsNCT02405416
Infrahepatic Inferior Vena Cava Clamping Versus Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping
A study testing Infrahepatic inferior vena cava clamping, Selective hepatic vascular exclusion and Portal triad clamping in people with Liver Neoplasms and Liver Cirrhosis, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in complex cirrhotic liver resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms, Liver Cirrhosis
- What is being tested?
- Infrahepatic inferior vena cava clamping, Selective hepatic vascular exclusion and Portal triad clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- either male or female, older than 18 (include 18).
- tumors oppress or be in close proximity to one or more of major hepatic veins.
- the maximum diameter of tumor ≥ 5cm, number of lesions ≤ 3 and should be in same liver lobe if multiple lesions exit.
- preoperative liver function assessment: Child-Pugh classification is A or B.
- preoperative laboratory test: blood platlet count > 100×10^9/l, prothrombin activity > 60%.
- liver cirrhosis.
Who cannot join
- contraindication for surgery,e.g.severe disorders of circulation, respiratory or renal system.
- extrahepatic metastasis in patients with malignancy or tumor invasion of portal vein, hepatic vein, bile duct or inferior vena cava.
- hepatectomy accompanied with other organs resection(e.g. bile duct, intestine, pancreas or stomach)
- regular hepatectomy.
- tumors located in the left lateral lobe of liver.
- previous hepatectomy.
- pregnancy or lactation.
- refusal to participate this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Xiaoping Chen, M.D., +86 27 83662851, chenxp@medmail.com.cn
Chao Wu, M.M., +86 18986136006, dr_wuchao@hust.edu.cn
About this study
Official title: A Prospective Randomized Controlled Trial to Compare Infrahepatic Inferior Vena Cava Clamping With Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping in Hepatectomy
This clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in complex cirrhotic liver resection. One group will receive IIVCC plus PTC, while an another equivalent group patients will be operated using SHVE and PTC.
Read the detailed description
Intraoperative blood loss is significantly associated with clinical outcomes of patients undergoing hepatectomy. There have been various hepatic vascular control techniques, including infrahepatic inferior vena cava clamping (IIVCC) and selective hepatic vascular exclusion (SHVE).The propose of this study is to compare these two surgical techniques combined with the portal triad clamping (PTC) in hepatic cirrhotic patients. All patients being performed hepatectomy at the center are scanned according to inclusion and exclusion criteria. After intraoperative exploration, patients are randomized into two interventional groups. PTC, IIVCC or SHVE is performed at the specified timepoint in liver parenchymal transection in two different groups. All data are collected prospectively.
- Conditions
- Liver Neoplasms, Liver Cirrhosis
- Being tested
- Infrahepatic inferior vena cava clamping, Selective hepatic vascular exclusion, Portal triad clamping
- Keywords
- Hepatocellular Carcinoma, Blood Loss, Haemorrhage, Vascular Control
- Medical subject headings
- Liver Neoplasms, Liver Cirrhosis, Carcinoma, Hepatocellular, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrahepatic inferior vena cava clampingProcedure or surgery
Also called IIVCC
Infrahepatic inferior vena cava is clamped in hepatectomy.
Selective hepatic vascular exclusionProcedure or surgery
Also called SHVE
Selected major hepatic vein is clamped in hepatectomy.
Portal triad clampingProcedure or surgery
Also called PTC
Portal triad are clamped in hepatectomy.
| Study group | Role | What they receive |
|---|---|---|
| IIVCC group | Experimental | The portal triad and infrahepatic inferior vena cava are dissected and taped with a vessel loop, respectively. During liver parenchymal resection，portal triad and infrahepatic inferior vena cava clampings are performed at the specified transection depth from liver surface successively. Receives: Procedure: Infrahepatic inferior vena cava clamping; Procedure: Portal triad clamping |
| SHVE group | Active comparator | In this group, the portal triad clamping and selective hepatic vascular exclusion of major hepatic veins are used. Different major hepatic veins are occluded by clamping forcep depending on the site of tumors. The clamping timepoints are same as the IIVCC group. Receives: Procedure: Selective hepatic vascular exclusion; Procedure: Portal triad clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
blood loss from incision to closure
Measured: Intraoperative period
Normalized transection-related blood loss
Intraoperative blood loss normalized by transection surface area
Measured: Intraoperative period
Secondary outcomes (7)
Time of infrahepatic inferior vena cava or selected hepatic vein dissection
Time cost of dissection
Measured: Intraoperative period
Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure
Measured: Intraoperative period
Drop of hemoglobin level
Measured: Drop of hemoglobin level will be measured during liver parenchymal transection period(neither the specific time point nor expected average could be given prospectively because of different surgical situations)
Postrecovery of liver function
Liver function evaluation is composite of liver enzyme ，total bilirubin, prothrombin activity, etc.
Measured: postoperative days 1, 3, 5, 7
Postrecovery of renal function
Renal function evaluation is composite of blood urea nitrogen, creatinine, etc.
Measured: postoperative days 1, 3, 5, 7
Morbidity of postoperative complications
Measured: 90 days after surgery
Postoperative mortality
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Chen, Huazhong University of Science and Technology
- Investigators
- Xiaoping Chen, M.D., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405416
- Sponsor's protocol ID
- chenxp006
- Other IDs
- 2012ZX10002016-004
- Status last verified
- Mar 2015
- First submitted
- 7 Mar 2015
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial to Compare Infrahepatic Inferior Vena Cava Clamping With Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping in Hepatectomy
- ClinicalTrials.gov ID
- NCT02405416
- Acronym / sponsor ID
- chenxp006
- Conditions
- Liver Neoplasms, Liver Cirrhosis
- Keywords
- Hepatocellular Carcinoma, Blood Loss, Haemorrhage, Vascular Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 1 Apr 2015 (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 clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in complex cirrhotic liver resection. One group will receive IIVCC plus PTC, while an another equivalent group patients will be operated using SHVE and PTC.
Detailed description
Intraoperative blood loss is significantly associated with clinical outcomes of patients undergoing hepatectomy. There have been various hepatic vascular control techniques, including infrahepatic inferior vena cava clamping (IIVCC) and selective hepatic vascular exclusion (SHVE).The propose of this study is to compare these two surgical techniques combined with the portal triad clamping (PTC) in hepatic cirrhotic patients. All patients being performed hepatectomy at the center are scanned according to inclusion and exclusion criteria. After intraoperative exploration, patients are randomized into two interventional groups. PTC, IIVCC or SHVE is performed at the specified timepoint in liver parenchymal transection in two different groups. All data are collected prospectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IIVCC group | Experimental | Procedure: Infrahepatic inferior vena cava clamping, Procedure: Portal triad clampingThe portal triad and infrahepatic inferior vena cava are dissected and taped with a vessel loop, respectively. During liver parenchymal resection，portal triad and infrahepatic inferior vena cava clampings are performed at the specified transection depth from liver surface successively. |
| SHVE group | Active comparator | Procedure: Selective hepatic vascular exclusion, Procedure: Portal triad clampingIn this group, the portal triad clamping and selective hepatic vascular exclusion of major hepatic veins are used. Different major hepatic veins are occluded by clamping forcep depending on the site of tumors. The clamping timepoints are same as the IIVCC group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- either male or female, older than 18 (include 18).
- tumors oppress or be in close proximity to one or more of major hepatic veins.
- the maximum diameter of tumor ≥ 5cm, number of lesions ≤ 3 and should be in same liver lobe if multiple lesions exit.
- preoperative liver function assessment: Child-Pugh classification is A or B.
- preoperative laboratory test: blood platlet count > 100×10^9/l, prothrombin activity > 60%.
Key exclusion criteria (8 listed)
- contraindication for surgery,e.g.severe disorders of circulation, respiratory or renal system.
- extrahepatic metastasis in patients with malignancy or tumor invasion of portal vein, hepatic vein, bile duct or inferior vena cava.
- hepatectomy accompanied with other organs resection(e.g. bile duct, intestine, pancreas or stomach)
- regular hepatectomy.
- tumors located in the left lateral lobe of liver.
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 |
|---|---|---|
| Infrahepatic inferior vena cava clampingAlso: IIVCCInfrahepatic inferior vena cava is clamped in hepatectomy. | Procedure or surgery | IIVCC group |
| Selective hepatic vascular exclusionAlso: SHVESelected major hepatic vein is clamped in hepatectomy. | Procedure or surgery | SHVE group |
| Portal triad clampingAlso: PTCPortal triad are clamped in hepatectomy. | Procedure or surgery | IIVCC group, SHVE group |
Primary outcome
Intraoperative blood loss
Time frame: Intraoperative period
blood loss from incision to closure
Normalized transection-related blood loss
Time frame: Intraoperative period
Intraoperative blood loss normalized by transection surface area
7 secondary outcomes
Time of infrahepatic inferior vena cava or selected hepatic vein dissection
Time frame: Intraoperative period
Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure
Time frame: Intraoperative period
Drop of hemoglobin level
Time frame: Drop of hemoglobin level will be measured during liver parenchymal transection period(neither the specific time point nor expected average could be given prospectively because of different surgical situations)
Postrecovery of liver function
Time frame: postoperative days 1, 3, 5, 7
Postrecovery of renal function
Time frame: postoperative days 1, 3, 5, 7
Morbidity of postoperative complications
Time frame: 90 days after surgery
Postoperative mortality
Time frame: 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
Related trials for Liver Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
Xiaoping Chen, M.D. study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrahepatic inferior vena cava clamping, Selective hepatic vascular exclusion and Portal triad clamping in people with Liver Neoplasms and Liver Cirrhosis, run by Huazhong University of Science and Technology at 1 site in China.
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 6 inclusion and 8 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 1 Apr 2015. 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 China. 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?
Contact Xiaoping Chen, M.D. (+86 27 83662851, chenxp@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: Intraoperative period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2015.