Laparoscopic HepatectomyNCT03422913
Controlled Low Central Venous Pressure Combined With Hilar Block in Laparoscopic Hepatectomy
A study of Laparoscopic Hepatectomy, run by Sun Yat-sen University at 1 site in China.
Trial summary
Hepatectomy is the preferred method for the treatment of liver tumors. Since the liver is a double blood supply organ, massive hemorrhage during hepatectomy may lead to hemodynamic instability, prolonged portal vein occlusion and increased ischemia-reperfusion injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopic Hepatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Jun 2018
- 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
- clinical diagnosis or pathological diagnosis of hepatocellular carcinoma;
- resectable non-left lobes, left and right liver lesions, and the resection range is expected to be greater than or equal to 1 liver segment, no non-cancerous thrombus; Indocyanine Green Retention Rate (ICGR) 15 minutes retention rate <10%
- did not receive systemic chemotherapy or other targeted drug therapy for diagnosing hepatocellular carcinoma(HCC) before participating in the study;
- generally good, Karnofsky Performance Scores (KPS) ≥ 80 points;
- Age: 18-70 years old
- Child-Pugh A level
- Baseline laboratory tests meet the following criteria:
- white blood cells ≥ 3.0 × 109 / L platelets ≥ 75 × 109 / L hemoglobin ≥ 100g / L serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) serum creatinine ≤ 1.5 x ULN International normalized ratio （INR）<1.4, or prothrombin time <ULN + 4 seconds albumin ≥ 30g / L Total bilirubin ≤34mmol / L
Who cannot join
- patients do not agree to participate in clinical studies;
- Any of the following had been reported in the 12 months prior to participating in the study: myocardial infarction, severe / unstable angina, coronary artery bypass surgery, congestive heart failure, cerebrovascular accident (including transient ischemic attack), Pulmonary Embolism; Ongoing: corrected QT interval prolongation (≥450 ms for males and> 470 ms for females) according to NCI-CTCAE criteria ≥2 arrhythmias;
- There are other serious acute and chronic physical or mental illnesses or laboratory abnormalities that may increase the risk associated with participating in study treatment or may interfere with the interpretation of the findings or in patients deemed inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country.
Li Xu contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhongguo Zhou, zhouzhg@sysucc.org.cn
About this study
Hepatectomy is the preferred method for the treatment of liver tumors. Since the liver is a double blood supply organ, massive hemorrhage during hepatectomy may lead to hemodynamic instability, prolonged portal vein occlusion and increased ischemia-reperfusion injury. In addition, bleeding during hepatectomy, intraoperative and postoperative blood transfusion are the main causes of postoperative morbidity and mortality. Therefore, bleeding control during liver resection is a critical technique. Based on the fact that liver is more tolerant to warm ischemia and hypoxia, a variety of techniques have been widely used for hepatic blood flow occlusion.
With the prevalence of laparoscopy, more patients received laparoscopic resection of liver cancer. Bleeding has become a major constraint, so how to reduce the bleeding and preserve liver function has always been surgeons' concern.As conventional hepatic portal blood flow blocking technology is more mature, the risk of bleeding during laparoscopic liver resection mainly comes from hepatic veins in the process of hepatic parenchymal isolation. Although Ultrasound scalpel and Ligasure have been widely accepted in the treatment of laparoscopic hepatectomy, due to the thin hepatic vein and the high intraluminal pressure, it is also difficult to control the bleeding during surgery. How to prevent hepatic venous hemorrhage has become the key to reduce the bleeding . As sinusoidal pressure is affected by intrahepatic pressure, which is directly related to central venous pressure (CVP), reducing CVP can reduce the pressure in the hepatic veins and sinusoids hence reducing bleeding when the hepatic parenchyma is severed. That is the rationale of controlled low central venous pressure CLCVP) to reduce the risk of hepatectomy, which have been used maturely in open hepatectomy. Due to the low risk of hepatic and renal insufficiency and gas embolism in liver surgery, there is a potential risk of laparoscopic pneumoperitoneum and the risk of laparoscopic pneumoperitoneum is further increased. Therefore, how to implement CLCVP in laparoscopic surgery to reduce the risk of bleeding, also avoiding complications such as bleeding gas embolism, is a clinical problem to be solved, is rarely reported. A prospective randomized controlled trial (RCT) will be performed for laparoscopic hepatectomy in patients combine intraoperative combined hilar intermittent (Pringle method) with or without CLCVP to reduce the bleeding. This study was to investigate the safety and efficacy of CLCVP in combination with intermittent Pringle.
- Conditions
- Laparoscopic Hepatectomy
- Being tested
- controlled low central venous pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlled low central venous pressureProcedure or surgery
Anesthesiologists will control the amount of fluid input and the use of composite intravenous anesthesia to make CVP at 0~5cm H2O, if CVP is still >5cm H2O, intravenous infusion of nitroglycerin will be used to reduce CVP. Maintaining arterial systolic blood pressure (SBP) > 90 mmHg, urine output more than 1ml/kg/h, and CVP was continuously monitored. Arterial pressure, pulse oxygen saturation ( SPO2), PaCO2 and electrocardiogram (II and V5 leads) were continuously monitored by radial artery cannulation. CVP will Returned to normal level (6 ~ 12 cmH2O) after resection to observe the wound if active bleeding still exist. Intraoperative hepatic blood flow blocking intermittent Pringle block method also required during surgery, 10-15 minutes for once, and more than 5 minutes interval can be repeated.
| Study group | Role | What they receive |
|---|---|---|
| CLCVP Group | Experimental | Controlled low central venous pressure(CLCVP) will be performed combined with intraoperative combined hilar intermittent (Pringle method) Receives: Procedure: controlled low central venous pressure |
| Control Group | No intervention | Only intraoperative combined hilar intermittent (Pringle method) will be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Blood loss in the two treatment groups were compared.
Measured: During surgery procedure
Secondary outcomes (2)
Safety
Incidence of gas embolism caused transient hypoxemia
Measured: During surgery procedure
Liver function recovery
blood test to show liver function recovery after surgery, that is elevation of transaminase
Measured: within 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Jul 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2018 (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 Laparoscopic HepatectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
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
- Investigators
- Zhongguo Zhou, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422913
- Sponsor's protocol ID
- B2017-073-01
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2018
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pan YX, Wang JC, Lu XY, Chen JB, He W, Chen JC, Wang XH, Fu YZ, Xu L, Zhang YJ, Chen MS, Lai RC, Zhou ZG. Intention to control low central venous pressure reduced blood loss during laparoscopic hepatectomy: A double-blind randomized clinical trial. Surgery. 2020 Jun;167(6):933-941. doi: 10.1016/j.surg.2020.02.004. Epub 2020 Mar 23.
PubMed 32216964
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Low Central Venous Pressure Combined With Hilar Block in Laparoscopic Hepatectomy
- ClinicalTrials.gov ID
- NCT03422913
- Acronym / sponsor ID
- B2017-073-01
- Conditions
- Laparoscopic Hepatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 6 Feb 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.
Hepatectomy is the preferred method for the treatment of liver tumors. Since the liver is a double blood supply organ, massive hemorrhage during hepatectomy may lead to hemodynamic instability, prolonged portal vein occlusion and increased ischemia-reperfusion injury. In addition, bleeding during hepatectomy, intraoperative and postoperative blood transfusion are the main causes of postoperative morbidity and mortality. Therefore, bleeding control during liver resection is a critical technique. Based on the fact that liver is more tolerant to warm ischemia and hypoxia, a variety of techniques have been widely used for hepatic blood flow occlusion.
With the prevalence of laparoscopy, more patients received laparoscopic resection of liver cancer. Bleeding has become a major constraint, so how to reduce the bleeding and preserve liver function has always been surgeons' concern.As conventional hepatic portal blood flow blocking technology is more mature, the risk of bleeding during laparoscopic liver resection mainly comes from hepatic veins in the process of hepatic parenchymal isolation. Although Ultrasound scalpel and Ligasure have been widely accepted in the treatment of laparoscopic hepatectomy, due to the thin hepatic vein and the high intraluminal pressure, it is also difficult to control the bleeding during surgery. How to prevent hepatic venous hemorrhage has become the key to reduce the bleeding . As sinusoidal pressure is affected by intrahepatic pressure, which is directly related to central venous pressure (CVP), reducing CVP can reduce the pressure in the hepatic veins and sinusoids hence reducing bleeding when the hepatic parenchyma is severed. That is the rationale of controlled low central venous pressure CLCVP) to reduce the risk of hepatectomy, which have been used maturely in open hepatectomy. Due to the low risk of hepatic and renal insufficiency and gas embolism in liver surgery, there is a potential risk of laparoscopic pneumoperitoneum and the risk of laparoscopic pneumoperitoneum is further increased. Therefore, how to implement CLCVP in laparoscopic surgery to reduce the risk of bleeding, also avoiding complications such as bleeding gas embolism, is a clinical problem to be solved, is rarely reported. A prospective randomized controlled trial (RCT) will be performed for laparoscopic hepatectomy in patients combine intraoperative combined hilar intermittent (Pringle method) with or without CLCVP to reduce the bleeding. This study was to investigate the safety and efficacy of CLCVP in combination with intermittent Pringle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLCVP Group | Experimental | Procedure: controlled low central venous pressureControlled low central venous pressure(CLCVP) will be performed combined with intraoperative combined hilar intermittent (Pringle method) |
| Control Group | No intervention | –Only intraoperative combined hilar intermittent (Pringle method) will be performed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- clinical diagnosis or pathological diagnosis of hepatocellular carcinoma;
- resectable non-left lobes, left and right liver lesions, and the resection range is expected to be greater than or equal to 1 liver segment, no non-cancerous thrombus; Indocyanine Green Retention Rate (ICGR) 15 minutes retention rate <10%
- did not receive systemic chemotherapy or other targeted drug therapy for diagnosing hepatocellular carcinoma(HCC) before participating in the study;
- generally good, Karnofsky Performance Scores (KPS) ≥ 80 points;
- Age: 18-70 years old
Key exclusion criteria (3 listed)
- patients do not agree to participate in clinical studies;
- Any of the following had been reported in the 12 months prior to participating in the study: myocardial infarction, severe / unstable angina, coronary artery bypass surgery, congestive heart failure, cerebrovascular accident (including transient ischemic attack), Pulmonary Embolism; Ongoing: corrected QT interval prolongation (≥450 ms for males and> 470 ms for females) according to NCI-CTCAE criteria ≥2 arrhythmias;
- There are other serious acute and chronic physical or mental illnesses or laboratory abnormalities that may increase the risk associated with participating in study treatment or may interfere with the interpretation of the findings or in patients deemed inappropriate by the investigator.
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 |
|---|---|---|
| controlled low central venous pressureAnesthesiologists will control the amount of fluid input and the use of composite intravenous anesthesia to make CVP at 0~5cm H2O, if CVP is still >5cm H2O, intravenous infusion of nitroglycerin will be used to reduce CVP. Maintaining arterial systolic blood pressure (SBP) > 90 mmHg, urine output more than 1ml/kg/h, and CVP was continuously monitored. Arterial pressure, pulse oxygen saturation ( SPO2), PaCO2 and electrocardiogram (II and V5 leads) were continuously monitored by radial artery cannulation. CVP will Returned to normal level (6 ~ 12 cmH2O) after resection to observe the wound if active bleeding still exist. Intraoperative hepatic blood flow blocking intermittent Pringle block method also required during surgery, 10-15 minutes for once, and more than 5 minutes interval can be repeated. | Procedure or surgery | CLCVP Group |
Primary outcome
Intraoperative blood loss
Time frame: During surgery procedure
Blood loss in the two treatment groups were compared.
2 secondary outcomes
Safety
Time frame: During surgery procedure
Liver function recovery
Time frame: within 5 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Derived from this study: PubMed 32216964Pan YX, Wang JC, Lu XY, Chen JB, He W, Chen JC, Wang XH, Fu YZ, Xu L, Zhang YJ, Chen MS, Lai RC, Zhou ZG. Intention to control low central venous pressure reduced blood loss during laparoscopic hepatectomy: A double-blind randomized clinical trial. Surgery. 2020 Jun;167(6):933-941. doi: 10.1016/j.surg.2020.02.004. Epub 2020 Mar 23.
- Individual participant dataSharing planned: Undecided
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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.
Li Xu contact
Zhongguo Zhou principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Laparoscopic Hepatectomy, run by Sun Yat-sen University 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 8 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 6 Feb 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 Wangqing Peng (86-20-87343115, pengwq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: During surgery procedure). 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 NCT03422913, 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 6 Feb 2018.