Laparoscopic Liver ResectionNCT03672357
Short and Long Outcomes Between Laparoscopic and Open Hepatectomy
A study testing Laparoscopic liver resection and Open liver resection in people with Laparoscopic Liver Resection and Open Liver Resection, run by hui hou at 1 site in China.
Trial summary
LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopic Liver Resection, Open Liver Resection
- What is being tested?
- Laparoscopic liver resection and Open liver resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Apr 2025
- 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
- Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for both open and laparoscopic liver resection;
- Child-Pugh A without portal hypertension
- No portosystemic shunt
- No previous abdominal operation history.
- American society of anesthesiology class(ASA): I or II
- Age 18 to 80
Who cannot join
- Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
- Combined hepatectomy
- Intrahepatic duct stone disease
- Liver disease caused splenomegaly
- Previous hepatectomy
- Combined operation for extrahepatic disease
- Vulnerable population (mental retardation, pregnancy)
Trial locations and contacts
1 site in 1 country.
China1 site
The second hospital of Anhui Medical University,
Hefei, Anhui, 230061
About this study
LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, due to the concerns over the risk of operative bleeding, tumor seeding and positive resection margin, the true benefit of LLR remains unclear across surgical community.
Read the detailed description
The 2nd International Consensus Conference on Laparoscopic Liver Resection (ICCLLR) was held in Morioka, Japan, in 2014. The new recommendations of the ICCLLR state that the outcomes of LLR are not inferior than OLR regarding to operative mortality rate and margin negativity, and are superior in decreasing postoperative complications, blood loss, and the length of the postoperative hospital stay. However, it is not clear that whether LLR is able to alleviate the impairment of liver function after hepatic resection, and there is no RCTs to compare the short and long outcomes between LLR and OLR.
- Conditions
- Laparoscopic Liver Resection, Open Liver Resection
- Being tested
- Laparoscopic liver resection, Open liver resection
- Keywords
- Liver resection, Laparoscopic surgery, fast recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic liver resectionProcedure or surgery
Laparoscopic hepatectomy
Open liver resectionProcedure or surgery
Traditional open hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic liver resection | Experimental | Laparoscopic hepatectomy Receives: Procedure: Laparoscopic liver resection |
| Open liver resection | Other | Open hepatectomy Receives: Procedure: Open liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum glutamic oxalacetic transaminase
Change of serum glutamic oxalacetic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.
Measured: up to 7 days after liver resection
Change of serum glutamic-pyruvic transaminase
Change of serum glutamic-pyruvic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.
Measured: up to 7 days after liver resection
Secondary outcomes (17)
Postoperative complication(Rates in different grades)
According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/
Measured: up to 30 days after liver resection
Mortality rates
the rate of postoperative death
Measured: up to 30 days after liver resection
Hospital duration after operation (days)
the length of hospital stay
Measured: up to 30 days after liver resection
Operation time(min)
the during of operation
Measured: up to 30 days after liver resection
Blood loss(ml)
the volume of blood loss
Measured: up to 30 days after liver resection
Blood transfusion (times and units)
intraoperative blood transfusion
Measured: intraoperative
Duration of nasogastric tubes (hours)
Duration of nasogastric tubes
Measured: up to 14 days after liver resection7
Duration of abdominal drain (days)
Duration of abdominal drain
Measured: up to 14 days after liver resection
Duration to first flatus (days)
Duration to first flatus
Measured: up to 14 days after liver resection
Comfort questionnaire measures (GCQ) measures by Kolcaba
GCQ measures by Kolcaba, download from http://www.thecomfortline.com/resources/cq.html.
Measured: up to 7 days after liver resection
Resection margin status
the R0 resection rate
Measured: up to 30 days after liver resection
Intensive care unit stay (days)
Intensive care unit stay in days
Measured: up to 7 days after liver resection
Readmission rate
measure the rate of readmission
Measured: up to 30 days after liver resection
C-reactive protein (mg/mL)
C-reactive protein levels on preoperative and postoperative day-1,3,5
Measured: up to 5 days after liver resection
Disease recurrence rates
The disease recurrence after operation
Measured: up to 5 years
Overall survival time (month)
Overall survival time after operation
Measured: up to 5 years after operation
Disease free survival time (month)
Disease free survival time after operation
Measured: up to 5 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Liver ResectionStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- hui hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, hui hou, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672357
- Sponsor's protocol ID
- LLR_01
- Status last verified
- Dec 2018
- First submitted
- 19 Aug 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Outcomes Between Laparoscopic and Open Hepatectomy
- ClinicalTrials.gov ID
- NCT03672357
- Acronym / sponsor ID
- LLR_01
- Conditions
- Laparoscopic Liver Resection, Open Liver Resection
- Keywords
- Liver resection, Laparoscopic surgery, fast recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- hui houUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 14 Sep 2018 (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.
LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, due to the concerns over the risk of operative bleeding, tumor seeding and positive resection margin, the true benefit of LLR remains unclear across surgical community.
Detailed description
The 2nd International Consensus Conference on Laparoscopic Liver Resection (ICCLLR) was held in Morioka, Japan, in 2014. The new recommendations of the ICCLLR state that the outcomes of LLR are not inferior than OLR regarding to operative mortality rate and margin negativity, and are superior in decreasing postoperative complications, blood loss, and the length of the postoperative hospital stay. However, it is not clear that whether LLR is able to alleviate the impairment of liver function after hepatic resection, and there is no RCTs to compare the short and long outcomes between LLR and OLR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic liver resection | Experimental | Procedure: Laparoscopic liver resectionLaparoscopic hepatectomy |
| Open liver resection | Other | Procedure: Open liver resectionOpen hepatectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for both open and laparoscopic liver resection;
- Child-Pugh A without portal hypertension
- No portosystemic shunt
- No previous abdominal operation history.
- American society of anesthesiology class(ASA): I or II
Key exclusion criteria (7 listed)
- Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
- Combined hepatectomy
- Intrahepatic duct stone disease
- Liver disease caused splenomegaly
- Previous hepatectomy
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 liver resectionLaparoscopic hepatectomy | Procedure or surgery | Laparoscopic liver resection |
| Open liver resectionTraditional open hepatectomy | Procedure or surgery | Open liver resection |
Primary outcome
Change of serum glutamic oxalacetic transaminase
Time frame: up to 7 days after liver resection
Change of serum glutamic oxalacetic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.
Change of serum glutamic-pyruvic transaminase
Time frame: up to 7 days after liver resection
Change of serum glutamic-pyruvic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.
17 secondary outcomes
Postoperative complication(Rates in different grades)
Time frame: up to 30 days after liver resection
Mortality rates
Time frame: up to 30 days after liver resection
Hospital duration after operation (days)
Time frame: up to 30 days after liver resection
Operation time(min)
Time frame: up to 30 days after liver resection
Blood loss(ml)
Time frame: up to 30 days after liver resection
Blood transfusion (times and units)
Time frame: intraoperative
Duration of nasogastric tubes (hours)
Time frame: up to 14 days after liver resection7
Duration of abdominal drain (days)
Time frame: up to 14 days after liver resection
Duration to first flatus (days)
Time frame: up to 14 days after liver resection
Comfort questionnaire measures (GCQ) measures by Kolcaba
Time frame: up to 7 days after liver resection
Resection margin status
Time frame: up to 30 days after liver resection
Intensive care unit stay (days)
Time frame: up to 7 days after liver resection
Readmission rate
Time frame: up to 30 days after liver resection
C-reactive protein (mg/mL)
Time frame: up to 5 days after liver resection
Disease recurrence rates
Time frame: up to 5 years
Overall survival time (month)
Time frame: up to 5 years after operation
Disease free survival time (month)
Time frame: up to 5 years after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- 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.
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 liver resection and Open liver resection in people with Laparoscopic Liver Resection and Open Liver Resection, run by hui hou 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 7 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 13 Dec 2018. 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 dachen zhou, MD (+8618160885015, zdc1987@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum glutamic oxalacetic transaminase (time frame: up to 7 days after liver resection). 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 13 Dec 2018.