Hepatocellular CarcinomaNCT02809287
A Novel Laparoscopic Hepatectomy Posture, Left Lateral Position Plus Jackknife Position
An observational study of Hepatocellular Carcinoma, run by Sun Yat-sen University.
Trial summary
Since the first report of laparoscopic resection of a benign hepatic tumor by Professor H. Reith in 1991, the laparoscope has been widely used in liver disease. Based on its advantages in laparoscopic vision and amplification, laparoscopic hepatectomy (LH) has been well recognized globally. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Jackknife posture
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were diagnosed with hepatocellular carcinoma (HCC) based on the criteria established by the European Association for the Study of the Liver
Who may be able to join
- Patients were diagnosed with hepatocellular carcinoma (HCC) based on the criteria established by the European Association for the Study of the Liver
- Tumor located in segment VI, VII, or VIII.
Who cannot join
- Major vessel or bile duct tumor invasion,
- Recurrent HCC
- Tumor close to secondary vessels and bile ducts
- Patients with extrahepatic metastasis
- Grade C liver function,
- Significant surgical contraindications
About this study
Official title: A Novel Laparoscopic Hepatectomy Posture, Left Lateral Position Plus Jackknife
Since the first report of laparoscopic resection of a benign hepatic tumor by Professor H. Reith in 1991, the laparoscope has been widely used in liver disease. Based on its advantages in laparoscopic vision and amplification, laparoscopic hepatectomy (LH) has been well recognized globally. Generally speaking, for lesions located in the left, front or lower part of the liver, corresponding to Couinaud segments II, III, IVb, V and VI, an LH surgery is recommended; however, for lesions located in segments VII and VIII, the surgery is high technically difficult due to poor exposure. Therefore,the investigators employ the left lateral position plus jackknife position to better expose lesions in these segments, hoping to reduce surgical time and bleeding in LH.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Jackknife posture
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jackknife postureProcedure or surgery
patients with left lateral position plus jackknife position when perform laparoscopic hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| study group | patients with left lateral position plus jackknife posture when perform laparoscopic hepatectomy Receives: Procedure: Jackknife posture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
evaluate the efficiency with this posture
Measured: intraoperative
Blood loss
evaluate the blood loss with this posture
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
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 Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongguo Zhou, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809287
- Sponsor's protocol ID
- 20160609
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chen JC, Zhang RX, Chen MS, Xu L, Chen JB, Yang KL, Zhang YJ, Zhou ZG. Left jackknife position: a novel position for laparoscopic hepatectomy. Chin J Cancer. 2017 Mar 20;36(1):31. doi: 10.1186/s40880-017-0190-y.
PubMed 28320486
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Laparoscopic Hepatectomy Posture, Left Lateral Position Plus Jackknife
- ClinicalTrials.gov ID
- NCT02809287
- Acronym / sponsor ID
- 20160609
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Jun 2016 (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.
Since the first report of laparoscopic resection of a benign hepatic tumor by Professor H. Reith in 1991, the laparoscope has been widely used in liver disease. Based on its advantages in laparoscopic vision and amplification, laparoscopic hepatectomy (LH) has been well recognized globally. Generally speaking, for lesions located in the left, front or lower part of the liver, corresponding to Couinaud segments II, III, IVb, V and VI, an LH surgery is recommended; however, for lesions located in segments VII and VIII, the surgery is high technically difficult due to poor exposure. Therefore,the investigators employ the left lateral position plus jackknife position to better expose lesions in these segments, hoping to reduce surgical time and bleeding in LH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Procedure: Jackknife posturepatients with left lateral position plus jackknife posture when perform laparoscopic hepatectomy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were diagnosed with hepatocellular carcinoma (HCC) based on the criteria established by the European Association for the Study of the Liver
Key inclusion criteria (2 listed)
- Patients were diagnosed with hepatocellular carcinoma (HCC) based on the criteria established by the European Association for the Study of the Liver
- Tumor located in segment VI, VII, or VIII.
Key exclusion criteria (6 listed)
- Major vessel or bile duct tumor invasion,
- Recurrent HCC
- Tumor close to secondary vessels and bile ducts
- Patients with extrahepatic metastasis
- Grade C liver function,
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 |
|---|---|---|
| Jackknife posturepatients with left lateral position plus jackknife position when perform laparoscopic hepatectomy | Procedure or surgery | study group |
Primary outcome
Operation time
Time frame: intraoperative
evaluate the efficiency with this posture
Blood loss
Time frame: intraoperative
evaluate the blood loss with this posture
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 22 Jun 2016.
- Derived from this study: PubMed 28320486Chen JC, Zhang RX, Chen MS, Xu L, Chen JB, Yang KL, Zhang YJ, Zhou ZG. Left jackknife position: a novel position for laparoscopic hepatectomy. Chin J Cancer. 2017 Mar 20;36(1):31. doi: 10.1186/s40880-017-0190-y.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Sun Yat-sen University.
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 2 inclusion and 6 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 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Operation time (time frame: intraoperative). 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?
On the ClinicalTrials.gov record for NCT02809287, 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 22 Jun 2016.