Hepatocellular CarcinomaNCT04422249
A Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy
A study testing laparoscopic middle hepatic vein guidance anatomic hemihepatectomy in people with Hepatocellular Carcinoma, run by Southwest Hospital, China at 1 site in China.
Trial summary
The study, entitled "RCT study of laparoscopic middle hepatic venous guidance versus conventional ananatomical hemihepatectomy", was designed to compare the efficacy of two different ananatomical hemihepatectomy procedures under laparoscopy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- laparoscopic middle hepatic vein guidance anatomic hemihepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2019to 23 Dec 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the site was limited to the patients who were suitable for dissecting hemihepatectomy；
- the type of disease was limited to hepatocellular carcinoma；
- the patients were generally able to tolerate anesthesia, the liver reserve function was good, and the patients were suitable for laparoscopic surgery；
- child-pugh grade A, no severe liver cirrhosis, portal hypertension, no extrahepatic and extrahepatic metastasis and main vascular invasion；
- the subjects who participated in this study indicated that they were willing to accept the two surgical methods and agreed to be randomly divided into groups during the operation；
- 18 ≤ age ≤ 70, male or female.
Who cannot join
- preoperative liver function Child-pugh grade B or C;
- patients with poor general condition and could not tolerate pneumoperitoneum or anesthesia;
- patients with severe liver cirrhosis, portal hypertension and lesions invading liver porta;
- patients with other treatment methods such as radio frequency ablation in addition to dissecting hepatectomy;
- repeated abdominal operations resulting in severe abdominal adhesion, unable to perform laparoscopic hepatectomy; male and female are not limited
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Shuguo Zheng, MD, 0086-13508308676, shuguozh@yahoo.com.cn
About this study
Official title: A RCT Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy
The study, entitled "RCT study of laparoscopic middle hepatic venous guidance versus conventional ananatomical hemihepatectomy", was designed to compare the efficacy of two different ananatomical hemihepatectomy procedures under laparoscopy.
Read the detailed description
Backgroud \& Aim:Hepatectomy is the main way to treat all kinds of liver surgical diseases, which can be divided into anatomic hepatectomy and non-anatomic hepatectomy.Among them, anatomic hepatectomy is suitable for primary liver cancer, hepatolithiasis and other benign and malignant diseases;It can be divided into hepatic venous guidance and non-hepatic venous guidance hepatectomy (traditional ananatomical hepatectomy).The aim of this study was to observe and compare the perioperative period and follow-up results of the two different laparoscopic surgical resection methods, and to provide high-level evidence-based medicine evidence for the selection of surgical methods for laparoscopic anatomical hemihepatectomy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- laparoscopic middle hepatic vein guidance anatomic hemihepatectomy
- Keywords
- Laparoscopic Middle hepatic vein Hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic middle hepatic vein guidance anatomic hemihepatectomyProcedure or surgery
Also called laparoscopic traditional anatomic hemihepatectomy
95 patients with primary HCC were divided into the middle hepatic vein guidance group(n=45) and the traditional group(n=45) according to the odd and even Numbers, and sealed into envelopes.Outcomes were monitored and evaluated during the 3-year follow-up period
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic middle hepatic vein guidance hemihepatectomy | Experimental | In theory, the advantages of anatomical hemihepatectomy guided by middle hepatic vein are as follows: 1) correctly guiding the transecting plane of the liver parenchyma can reduce the cross-sectional area of the liver and avoid damaging the vascular ducts of the pre-cut liver. so as to reduce the residue of necrotic tissue without blood supply and reduce the occurrence of postoperative complications. 2) active anatomy and exposure of hepatic vein can avoid uncontrollable bleeding after passive injury of hepatic vein, and laparoscopic anatomy has obvious advantage in exposing hepatic vein. 3) it may reduce the early recurrence rate of hepatocellular carcinoma after operation. Receives: Procedure: laparoscopic middle hepatic vein guidance anatomic hemihepatectomy |
| laparoscopic traditional anatomic hemihepatectomy | Active comparator | According to textbooks and the views of some scholars at present, traditional anatomical hepatectomy (non-hepatic vein-guided anatomical hepatectomy) has the following advantages: 1) avoiding exposure of hepatic vein can reduce the probability of injury to the trunk of hepatic vein, thus reduce the risk of massive bleeding during operation; 2) the difficulty of operation is relatively low, and a better short-term and long-term effect can be obtained. Receives: Procedure: laparoscopic middle hepatic vein guidance anatomic hemihepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
follow-up after the surgery every 3 months, to understand statistics 1-year overall survival、3-year overall survival、1-year disease-free survival、3-year disease-free survival
Measured: 3 years
Secondary outcomes (2)
Perioperative results
the angle of hepatic vein between segment Ⅳ b and Ⅴ, angle between MHV and IVC
Measured: Duration perioperation(an expected average of 3 days)
intraoperative parameters
blood loss per unit area will be combined to report intraoperative parameters in milliliter/square centimetre(ml/c㎡）
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start23 Dec 2019
- Primary completion23 Dec 2023 (estimated)
- Study completion23 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuguo Zheng, MD, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422249
- Sponsor's protocol ID
- SWHZSG009
- Status last verified
- Dec 2023
- First submitted
- 20 May 2020
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy
- ClinicalTrials.gov ID
- NCT04422249
- Acronym / sponsor ID
- SWHZSG009
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Laparoscopic Middle hepatic vein Hepatocellular carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 23 Dec 2023 (estimated)
- Study completion
- 23 Dec 2023 (estimated)
- First posted
- 9 Jun 2020 (actual)
- 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 study, entitled "RCT study of laparoscopic middle hepatic venous guidance versus conventional ananatomical hemihepatectomy", was designed to compare the efficacy of two different ananatomical hemihepatectomy procedures under laparoscopy.
Detailed description
Backgroud \& Aim:Hepatectomy is the main way to treat all kinds of liver surgical diseases, which can be divided into anatomic hepatectomy and non-anatomic hepatectomy.Among them, anatomic hepatectomy is suitable for primary liver cancer, hepatolithiasis and other benign and malignant diseases;It can be divided into hepatic venous guidance and non-hepatic venous guidance hepatectomy (traditional ananatomical hepatectomy).The aim of this study was to observe and compare the perioperative period and follow-up results of the two different laparoscopic surgical resection methods, and to provide high-level evidence-based medicine evidence for the selection of surgical methods for laparoscopic anatomical hemihepatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic middle hepatic vein guidance hemihepatectomy | Experimental | Procedure: laparoscopic middle hepatic vein guidance anatomic hemihepatectomyIn theory, the advantages of anatomical hemihepatectomy guided by middle hepatic vein are as follows: 1) correctly guiding the transecting plane of the liver parenchyma can reduce the cross-sectional area of the liver and avoid damaging the vascular ducts of the pre-cut liver. so as to reduce the residue of necrotic tissue without blood supply and reduce the occurrence of postoperative complications. 2) active anatomy and exposure of hepatic vein can avoid uncontrollable bleeding after passive injury of hepatic vein, and laparoscopic anatomy has obvious advantage in exposing hepatic vein. 3) it may reduce the early recurrence rate of hepatocellular carcinoma after operation. |
| laparoscopic traditional anatomic hemihepatectomy | Active comparator | Procedure: laparoscopic middle hepatic vein guidance anatomic hemihepatectomyAccording to textbooks and the views of some scholars at present, traditional anatomical hepatectomy (non-hepatic vein-guided anatomical hepatectomy) has the following advantages: 1) avoiding exposure of hepatic vein can reduce the probability of injury to the trunk of hepatic vein, thus reduce the risk of massive bleeding during operation; 2) the difficulty of operation is relatively low, and a better short-term and long-term effect can be obtained. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- the site was limited to the patients who were suitable for dissecting hemihepatectomy；
- the type of disease was limited to hepatocellular carcinoma；
- the patients were generally able to tolerate anesthesia, the liver reserve function was good, and the patients were suitable for laparoscopic surgery；
- child-pugh grade A, no severe liver cirrhosis, portal hypertension, no extrahepatic and extrahepatic metastasis and main vascular invasion；
- the subjects who participated in this study indicated that they were willing to accept the two surgical methods and agreed to be randomly divided into groups during the operation；
Key exclusion criteria (5 listed)
- preoperative liver function Child-pugh grade B or C;
- patients with poor general condition and could not tolerate pneumoperitoneum or anesthesia;
- patients with severe liver cirrhosis, portal hypertension and lesions invading liver porta;
- patients with other treatment methods such as radio frequency ablation in addition to dissecting hepatectomy;
- repeated abdominal operations resulting in severe abdominal adhesion, unable to perform laparoscopic hepatectomy; male and female are not limited
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 |
|---|---|---|
| laparoscopic middle hepatic vein guidance anatomic hemihepatectomyAlso: laparoscopic traditional anatomic hemihepatectomy95 patients with primary HCC were divided into the middle hepatic vein guidance group(n=45) and the traditional group(n=45) according to the odd and even Numbers, and sealed into envelopes.Outcomes were monitored and evaluated during the 3-year follow-up period | Procedure or surgery | laparoscopic middle hepatic vein guidance hemihepatectomy, laparoscopic traditional anatomic hemihepatectomy |
Primary outcome
Survival rate
Time frame: 3 years
follow-up after the surgery every 3 months, to understand statistics 1-year overall survival、3-year overall survival、1-year disease-free survival、3-year disease-free survival
2 secondary outcomes
Perioperative results
Time frame: Duration perioperation(an expected average of 3 days)
intraoperative parameters
Time frame: during the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic middle hepatic vein guidance anatomic hemihepatectomy in people with Hepatocellular Carcinoma, run by Southwest Hospital, China 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 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 26 Dec 2023. 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 Shuguo Zheng, M.D. (0086-13508308676, shuguozh@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 3 years). 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 26 Dec 2023.