Benign Lesions in Left LiverNCT01768728
Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions
A study testing Laparoscopic left hemihepatectomy and Open left hemihepatectomy in people with Benign Lesions in Left Liver, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the influence of the laparoscopic and open left hemihepatectomy on acute surgical trauma and stress response. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Benign Lesions in Left Liver
- What is being tested?
- Laparoscopic left hemihepatectomy and Open left hemihepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Sep 2015
- 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
- patient with benign lesions who requires left hemihepatectomy
- Child-Pugh classification of A to B
- American Society Of Anesthesiologists (ASA) grading of I to III
- a body mass index of between 18 and 35
- willingness to participate in the study
- able to understand the nature of the study and what will be required of them
Who cannot join
- pregnant or lactating women
- unwillingness to participate
- Child-Pugh classification of C
- ASA grading of IV to V
- with condition of acute inflammatory,fever or diabetes mellitus
- with autoimmune disease or immunodeficiency
- taking drugs that affect the immune system
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
About this study
Official title: A Randomized Controlled Trial of Acute Surgical Trauma and Stress Response of Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions
The purpose of this study is to investigate the influence of the laparoscopic and open left hemihepatectomy on acute surgical trauma and stress response.
- Conditions
- Benign Lesions in Left Liver
- Being tested
- Laparoscopic left hemihepatectomy, Open left hemihepatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic left hemihepatectomyProcedure or surgery
Also called Laparoscopic left hepatectomy
participants will be performed with laparoscopic left hepatectomy using laparoscopic instruments
Open left hemihepatectomyProcedure or surgery
Also called Open left hepatectomy
participants will be performed with traditional open left hepatectomy using laparotomic instruments
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic left hemihepatectomy group | Active comparator | Group of patients that are operated with laparoscopic left hemihepatectomy Receives: Procedure: Laparoscopic left hemihepatectomy |
| Open left hemihepatectomy | Active comparator | Group of patients operated with open left hemihepatectomy Receives: Procedure: Open left hemihepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma C-reactive protein (CRP) level
CRP will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
Measured: up to 7 days
Secondary outcomes (11)
Inflammatory response markers including interleukin-6, interleukin-10 concentrations and tumor necrosis factor α level in serum
interleukin-6 and interleukin-10 will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
Measured: up to 7 days
Oxidative stress status including plasma malondialdehyde level and total antioxidant capacity
plasma malondialdehyde level and total antioxidant capacity will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
Measured: up to 7 days
Immune status including white blood cell count and human leukocyte antigen DR (HLA-DR) expression
white blood cell count and human leukocyte antigen DR (HLA-DR) expression will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
Measured: up to 7 days
Status of insulin resistant
Status of insulin resistant will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
Measured: up to 7 days
Systemic inflammatory response syndrome
Measured: up to 7 days
Status of hepatic cell apoptosis including hematoxylin and eosin (HE) staining, immunohistochemistry staining and caspase-3 expression
Measured: 24 hours
Time to functional recovery
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Postoperative hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Morbidity and mortality
Measured: up to 1 month
Quality of life
Measured: up to 1 month
Intraoperative parameters including operation time, pneumoperitoneum time, liver resection time, intraoperative estimated blood loss,transfusion
Measured: participants will be followed for the duration of operation, an expected average of 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Lesions in Left LiverStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiujun Cai, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768728
- Sponsor's protocol ID
- SRRSH20121225-1
- Status last verified
- Nov 2015
- First submitted
- 9 Jan 2013
- Last updated
- 18 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Acute Surgical Trauma and Stress Response of Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions
- ClinicalTrials.gov ID
- NCT01768728
- Acronym / sponsor ID
- SRRSH20121225-1
- Conditions
- Benign Lesions in Left Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2015 (actual)
- First posted
- 15 Jan 2013 (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.
The purpose of this study is to investigate the influence of the laparoscopic and open left hemihepatectomy on acute surgical trauma and stress response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic left hemihepatectomy group | Active comparator | Procedure: Laparoscopic left hemihepatectomyGroup of patients that are operated with laparoscopic left hemihepatectomy |
| Open left hemihepatectomy | Active comparator | Procedure: Open left hemihepatectomyGroup of patients operated with open left hemihepatectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient with benign lesions who requires left hemihepatectomy
- Child-Pugh classification of A to B
- American Society Of Anesthesiologists (ASA) grading of I to III
- a body mass index of between 18 and 35
- willingness to participate in the study
Key exclusion criteria (7 listed)
- pregnant or lactating women
- unwillingness to participate
- Child-Pugh classification of C
- ASA grading of IV to V
- with condition of acute inflammatory,fever or diabetes mellitus
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 left hemihepatectomyAlso: Laparoscopic left hepatectomyparticipants will be performed with laparoscopic left hepatectomy using laparoscopic instruments | Procedure or surgery | Laparoscopic left hemihepatectomy group |
| Open left hemihepatectomyAlso: Open left hepatectomyparticipants will be performed with traditional open left hepatectomy using laparotomic instruments | Procedure or surgery | Open left hemihepatectomy |
Primary outcome
Plasma C-reactive protein (CRP) level
Time frame: up to 7 days
CRP will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
11 secondary outcomes
Inflammatory response markers including interleukin-6, interleukin-10 concentrations and tumor necrosis factor α level in serum
Time frame: up to 7 days
Oxidative stress status including plasma malondialdehyde level and total antioxidant capacity
Time frame: up to 7 days
Immune status including white blood cell count and human leukocyte antigen DR (HLA-DR) expression
Time frame: up to 7 days
Status of insulin resistant
Time frame: up to 7 days
Systemic inflammatory response syndrome
Time frame: up to 7 days
Status of hepatic cell apoptosis including hematoxylin and eosin (HE) staining, immunohistochemistry staining and caspase-3 expression
Time frame: 24 hours
Time to functional recovery
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Postoperative hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Morbidity and mortality
Time frame: up to 1 month
Quality of life
Time frame: up to 1 month
Intraoperative parameters including operation time, pneumoperitoneum time, liver resection time, intraoperative estimated blood loss,transfusion
Time frame: participants will be followed for the duration of operation, an expected average of 120 minutes
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 18 Nov 2015.
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.
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 left hemihepatectomy and Open left hemihepatectomy in people with Benign Lesions in Left Liver, run by Sir Run Run Shaw Hospital 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: finished, as of the sponsor's last update on 18 Nov 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?
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?
Plasma C-reactive protein (CRP) level (time frame: up to 7 days). 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 18 Nov 2015.