Hepatobiliary DiseasePhase 3NCT02197481
Usefulness of BiClamp Forceps for Liver Resection: A Randomized Clinical Trial
A Phase 3 study testing Clamp-Crushing technique and BiClamp forceps in people with Hepatobiliary Disease, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial summary
The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic resection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatobiliary Disease
- What is being tested?
- Clamp-Crushing technique and BiClamp forceps
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to May 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both male and female, aged 18 or older
- Patients scheduled to undergo hepatic resection for some benign or malignant hepatobiliary disease
- Child-Pugh class A or B liver function
- BiClamp forceps hepatectomy and clamp-crushing feasible based on preoperative imaging
- No tumor invasion the main vein, hepatic artery and vein and major inferior vena cava
- No extrahepatic metastasis
- Voluntary participation in the study, and informed consent.
Who cannot join
- Age <18 years or> 65 years , pregnant or lactating women
- Preoperative liver function evaluation: Child-Pugh C grade
- Laparoscopic hepatectomy
- Extrahepatic metastasis
- Tumor invasion the main vein, hepatic artery and vein and major inferior vena cava
- The patient refused to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
About this study
Official title: BiClamp Forceps Liver Transection Versus Clamp Crushing Technique in Liver Resections: A Randomized Clinical Trial
The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic resection.
Read the detailed description
Background: Blood loss and the need for blood transfusions during the liver transection have shown to be correlated with higher morbidity and mortality rates and with worsen prognosis. Various devices of liver parenchymal transection have been developed with a view to reducing the intraoperative blood loss. However, to the present there is no randomized controlled trial evaluating the technique of BiClamp forceps during the liver transection. The goal of the present study was to evaluate the safety and effectiveness of BiClamp forceps transection in comparison to the clamp crushing technique in patients offered liver resection.
Intervention: One hundred patients with hepatobiliary disease need undergo hepatectomy at Anhui medical university were selected and divided into BiClamp forceps hepatectomy group and clamp-crushing hepatectomy group, each group contains 50 cases.
Results:
- Clinical data include: blood loss during liver transection, total blood loss, blood transfusion, hospital stay, morbidity, mortality, biliary leakage, postoperative liver function, liver transection time, operation time, resection margins, need for portal trial clamping.
- Statistical method: groups t-test, univariate/multivariate analysis, logistic regression analysis, mixed linear regression and Cox survival analysis were used.
- Conditions
- Hepatobiliary Disease
- Being tested
- Clamp-Crushing technique, BiClamp forceps
- Keywords
- BiClamp forceps hepatectomy, Clamp crushing technique, Liver parenchyma transection, Randomized controlled trial
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clamp-Crushing techniqueProcedure or surgery
Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
BiClamp forcepsDevice
liver transection during hepatectomy by BiClamp forceps
| Study group | Role | What they receive |
|---|---|---|
| Clamp-Crushing technique | Active comparator | liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted Receives: Procedure: Clamp-Crushing technique |
| BiClamp forceps hepatectomy | Experimental | The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study. Receives: Device: BiClamp forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Total Blood Loss
Blood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection
Measured: an expected average of 80 minutes
Secondary outcomes (7)
Liver Transection Time
liver transection time was calculated from the beginning to the end of the liver resection
Measured: an expected average of 40 minutes
Mortality
Operative mortality was defined as any death resulting from a complication during surgery
Measured: 90 days
Morbidity
Measured: 90 days
Biliary Leakage
Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems
Measured: 90 days
Duration of Postoperative Hospital Stay
Time from day of operation to day of discharge
Measured: an expected average of 12 days
Number of Participants Requiring a Blood Transfusion
Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively
Measured: 2 days
Total Bilirubin
serum total bilirubin on 3 postoperative day (umol/L)
Measured: 3 postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatobiliary DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Responsible party
- Principal investigator, xpgeng, The Second Hospital of Anhui Medical University
- Investigators
- Geng Xiaoping, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197481
- Sponsor's protocol ID
- ahykdxdefsyy10
- Status last verified
- May 2017
- First submitted
- 15 Jul 2014
- Last updated
- 14 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kooby DA, Stockman J, Ben-Porat L, Gonen M, Jarnagin WR, Dematteo RP, Tuorto S, Wuest D, Blumgart LH, Fong Y. Influence of transfusions on perioperative and long-term outcome in patients following hepatic resection for colorectal metastases. Ann Surg. 2003 Jun;237(6):860-9; discussion 869-70. doi: 10.1097/01.SLA.0000072371.95588.DA.
PubMed 12796583Gurusamy KS, Pamecha V, Sharma D, Davidson BR. Techniques for liver parenchymal transection in liver resection. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006880. doi: 10.1002/14651858.CD006880.pub2.
PubMed 19160307Itoh S, Fukuzawa K, Shitomi Y, Okamoto M, Kinoshita T, Taketomi A, Shirabe K, Wakasugi K, Maehara Y. Impact of the VIO system in hepatic resection for patients with hepatocellular carcinoma. Surg Today. 2012 Dec;42(12):1176-82. doi: 10.1007/s00595-012-0306-6. Epub 2012 Sep 20.
PubMed 22993104Chen JM, Geng W, Liu FB, Zhao HC, Xie SX, Hou H, Zhao YJ, Wang GB, Geng XP. BiClamp(R) forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial. Trials. 2015 Apr 30;16:201. doi: 10.1186/s13063-015-0722-1.
PubMed 25925431
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiClamp Forceps Liver Transection Versus Clamp Crushing Technique in Liver Resections: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02197481
- Acronym / sponsor ID
- ahykdxdefsyy10
- Conditions
- Hepatobiliary Disease
- Keywords
- BiClamp forceps hepatectomy, Clamp crushing technique, Liver parenchyma transection, Randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Posted 14 Dec 2017
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 compare short-term and long-term efficacy of BiClamp forceps hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic resection.
Detailed description
Background: Blood loss and the need for blood transfusions during the liver transection have shown to be correlated with higher morbidity and mortality rates and with worsen prognosis. Various devices of liver parenchymal transection have been developed with a view to reducing the intraoperative blood loss. However, to the present there is no randomized controlled trial evaluating the technique of BiClamp forceps during the liver transection. The goal of the present study was to evaluate the safety and effectiveness of BiClamp forceps transection in comparison to the clamp crushing technique in patients offered liver resection.
Intervention: One hundred patients with hepatobiliary disease need undergo hepatectomy at Anhui medical university were selected and divided into BiClamp forceps hepatectomy group and clamp-crushing hepatectomy group, each group contains 50 cases.
Results:
- Clinical data include: blood loss during liver transection, total blood loss, blood transfusion, hospital stay, morbidity, mortality, biliary leakage, postoperative liver function, liver transection time, operation time, resection margins, need for portal trial clamping.
- Statistical method: groups t-test, univariate/multivariate analysis, logistic regression analysis, mixed linear regression and Cox survival analysis were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clamp-Crushing technique | Active comparator | Procedure: Clamp-Crushing techniqueliver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted |
| BiClamp forceps hepatectomy | Experimental | Device: BiClamp forcepsThe BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both male and female, aged 18 or older
- Patients scheduled to undergo hepatic resection for some benign or malignant hepatobiliary disease
- Child-Pugh class A or B liver function
- BiClamp forceps hepatectomy and clamp-crushing feasible based on preoperative imaging
- No tumor invasion the main vein, hepatic artery and vein and major inferior vena cava
Key exclusion criteria (6 listed)
- Age <18 years or> 65 years , pregnant or lactating women
- Preoperative liver function evaluation: Child-Pugh C grade
- Laparoscopic hepatectomy
- Extrahepatic metastasis
- Tumor invasion the main vein, hepatic artery and vein and major inferior vena cava
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 |
|---|---|---|
| Clamp-Crushing techniqueLiver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps | Procedure or surgery | Clamp-Crushing technique |
| BiClamp forcepsliver transection during hepatectomy by BiClamp forceps | Device | BiClamp forceps hepatectomy |
Primary outcome
The Total Blood Loss
Time frame: an expected average of 80 minutes
Blood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection
7 secondary outcomes
Liver Transection Time
Time frame: an expected average of 40 minutes
Mortality
Time frame: 90 days
Morbidity
Time frame: 90 days
Biliary Leakage
Time frame: 90 days
Duration of Postoperative Hospital Stay
Time frame: an expected average of 12 days
Number of Participants Requiring a Blood Transfusion
Time frame: 2 days
Total Bilirubin
Time frame: 3 postoperative day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 12796583Kooby DA, Stockman J, Ben-Porat L, Gonen M, Jarnagin WR, Dematteo RP, Tuorto S, Wuest D, Blumgart LH, Fong Y. Influence of transfusions on perioperative and long-term outcome in patients following hepatic resection for colorectal metastases. Ann Surg. 2003 Jun;237(6):860-9; discussion 869-70. doi: 10.1097/01.SLA.0000072371.95588.DA.
- Results publication: PubMed 19160307Gurusamy KS, Pamecha V, Sharma D, Davidson BR. Techniques for liver parenchymal transection in liver resection. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006880. doi: 10.1002/14651858.CD006880.pub2.
- Results publication: PubMed 22993104Itoh S, Fukuzawa K, Shitomi Y, Okamoto M, Kinoshita T, Taketomi A, Shirabe K, Wakasugi K, Maehara Y. Impact of the VIO system in hepatic resection for patients with hepatocellular carcinoma. Surg Today. 2012 Dec;42(12):1176-82. doi: 10.1007/s00595-012-0306-6. Epub 2012 Sep 20.
- Derived from this study: PubMed 25925431Chen JM, Geng W, Liu FB, Zhao HC, Xie SX, Hou H, Zhao YJ, Wang GB, Geng XP. BiClamp(R) forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial. Trials. 2015 Apr 30;16:201. doi: 10.1186/s13063-015-0722-1.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatobiliary Disease
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Recruiting
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Liver Diseases
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.
Geng Xiaoping principal investigator
The Second Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clamp-Crushing technique and BiClamp forceps in people with Hepatobiliary Disease, run by The Second Hospital of Anhui Medical 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 7 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 14 Dec 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Total Blood Loss (time frame: an expected average of 80 minutes). 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 NCT02197481, which also lists 4 linked publications.
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 14 Dec 2017.