Cancer ProgressionNCT02319863
Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy
A study testing hepatectomy (conventional method) and hepatectomy (rapid ligating) in people with Cancer Progression, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study examines the role of this simple technique on postoperative metastasis and long term survival. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer Progression
- What is being tested?
- hepatectomy (conventional method) and hepatectomy (rapid ligating)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Feb 1994to Dec 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCC patients who will perform left- or right- hemihepatectomy.
Who cannot join
- contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C,indocyanine green retention rate at 15min (ICGR15)>30%,serum hepatitis B virus (HBV)-DNA>106 copies/ml and serum alanine aminotransferase (ALT)>2×ULN, serum triglycerides>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause;
- pregnancy;
- age of<18y or>65y
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
Binhao Zhang, M.D., +86 15802726021, bhzhang8@gmail.com
About this study
Official title: A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy
This study examines the role of this simple technique on postoperative metastasis and long term survival.
Read the detailed description
The only hope of long-term survival for patients with primary hepatocellular carcinoma (HCC) is surgical resection or liver transplantation, the former of which is more feasible at present. However, postoperative recurrence or metastasis is an ominous feature for this disease. Innovation of the surgical procedure for improving prognosis is under emergency request. This study examines the role of this simple technique on postoperative metastasis and long term survival.
During the past 20 years, more 600 patients with primary HCC were performed hepatectomy with the new hemorrhage control technique, and prospective randomized controlled trial (RCT) was applied. We further applied a mice model ligating the pedicle of the lesion-located hepatic lobe before hepatectomy to imitate the clinic practice, and evaluated the role of the new technique on postoperative metastasis and survival.
- Conditions
- Cancer Progression
- Being tested
- hepatectomy (conventional method), hepatectomy (rapid ligating)
- Keywords
- hepatocellular carcinoma, prognosis
- Medical subject headings
- Disease Progression, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatectomy (conventional method)Procedure or surgery
Also called liver resection
A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy
hepatectomy (rapid ligating)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| conventional resection | Active comparator | Perform hepatectomy with conventional method for HCC patients. Receives: Procedure: hepatectomy (conventional method) |
| new method | Experimental | The new technique of rapid ligating the corresponding inflow and outflow vessels without hills dissection before parenchyma transection during hepatectomy. Receives: Procedure: hepatectomy (rapid ligating) |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
to examine if there is intrahepatic recurrence
Measured: 12 months
metastasis
to examine if there is intrahepatic metastasis and metastasis in distant organs
Measured: 12 months
mortality
intraoperative death， and death in one month after surgery
Measured: 1 month
Secondary outcomes (1)
Prognosis
to check the 5 years overall survival (OS) and disease free survival (DFS)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startFeb 1994
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
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 Cancer ProgressionStudies 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
- None (open label)
- Enrolment
- 600 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., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319863
- Sponsor's protocol ID
- Chenxp5
- Other IDs
- 2012ZX10002016-004
- Status last verified
- Dec 2014
- First submitted
- 11 Dec 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen XP, Qiu FZ. A simple technique ligating the corresponding inflow and outflow vessels during anatomical left hepatectomy. Langenbecks Arch Surg. 2008 Mar;393(2):227-30; discussion 231-4. doi: 10.1007/s00423-007-0224-z. Epub 2007 Nov 3.
PubMed 17978838
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy
- ClinicalTrials.gov ID
- NCT02319863
- Acronym / sponsor ID
- Chenxp5
- Conditions
- Cancer Progression
- Keywords
- hepatocellular carcinoma, prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Feb 1994
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 18 Dec 2014 (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 study examines the role of this simple technique on postoperative metastasis and long term survival.
Detailed description
The only hope of long-term survival for patients with primary hepatocellular carcinoma (HCC) is surgical resection or liver transplantation, the former of which is more feasible at present. However, postoperative recurrence or metastasis is an ominous feature for this disease. Innovation of the surgical procedure for improving prognosis is under emergency request. This study examines the role of this simple technique on postoperative metastasis and long term survival.
During the past 20 years, more 600 patients with primary HCC were performed hepatectomy with the new hemorrhage control technique, and prospective randomized controlled trial (RCT) was applied. We further applied a mice model ligating the pedicle of the lesion-located hepatic lobe before hepatectomy to imitate the clinic practice, and evaluated the role of the new technique on postoperative metastasis and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional resection | Active comparator | Procedure: hepatectomy (conventional method)Perform hepatectomy with conventional method for HCC patients. |
| new method | Experimental | Procedure: hepatectomy (rapid ligating)The new technique of rapid ligating the corresponding inflow and outflow vessels without hills dissection before parenchyma transection during hepatectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HCC patients who will perform left- or right- hemihepatectomy.
Key exclusion criteria (3 listed)
- contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C,indocyanine green retention rate at 15min (ICGR15)>30%,serum hepatitis B virus (HBV)-DNA>106 copies/ml and serum alanine aminotransferase (ALT)>2×ULN, serum triglycerides>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause;
- pregnancy;
- age of<18y or>65y
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 |
|---|---|---|
| hepatectomy (conventional method)Also: liver resectionA Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy | Procedure or surgery | conventional resection |
| hepatectomy (rapid ligating) | Procedure or surgery | new method |
Primary outcome
recurrence
Time frame: 12 months
to examine if there is intrahepatic recurrence
metastasis
Time frame: 12 months
to examine if there is intrahepatic metastasis and metastasis in distant organs
mortality
Time frame: 1 month
intraoperative death， and death in one month after surgery
1 secondary outcome
Prognosis
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Background: PubMed 17978838Chen XP, Qiu FZ. A simple technique ligating the corresponding inflow and outflow vessels during anatomical left hepatectomy. Langenbecks Arch Surg. 2008 Mar;393(2):227-30; discussion 231-4. doi: 10.1007/s00423-007-0224-z. Epub 2007 Nov 3.
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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.
Xiaoping Chen, M.D. principal investigator
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 hepatectomy (conventional method) and hepatectomy (rapid ligating) in people with Cancer Progression, 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 1 inclusion and 3 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 18 Dec 2014. 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?
recurrence (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT02319863, 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 18 Dec 2014.