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| Name | Class |
|---|---|
| The First Affiliated Hospital of Anhui Medical University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clamp-Crushing technique | Active Comparator | liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clamp-Crushing technique | Procedure | Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | an expected average of 80 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Transection Time | liver transection time was calculated from the beginning to the end of the liver resection | an expected average of 40 minutes |
| Mortality | Operative mortality was defined as any death resulting from a complication during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geng Xiaoping | The Second Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12796583 | Result | 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. | |
| 19160307 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| PMID:25925431 | Study Protocol | View IPD |
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Patients undergoing concomitant vascular resection or bile duct resection and those undergoing emergency liver resection were excluded.
Eligibility criteria included scheduled liver resection for benign or malignant hepatobiliary disease and a minimum age of 18 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clamp-Crushing Technique | liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted Clamp-Crushing technique: Liver transection during hepatectomy by monopole electric knife and blood vessel forceps, but without BiClamp forceps |
| FG001 | BiClamp Forceps Hepatectomy | 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. BiClamp forceps: liver transection during hepatectomy by BiClamp forceps |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clamp-Crushing Technique | liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | ml | an expected average of 80 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clamp-Crushing Technique | liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| biliary leakage | Hepatobiliary disorders | Clavien-Dindo | Systematic Assessment | percutaneous drainage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pleural effusions | General disorders | Clavien-Dindo | Non-systematic Assessment |
Owing to the small number of patients, no subgroup analysis based in type of hepatic resection or hepatic portal occlusion, So it is unclear whether the advantage of BiClamp® forceps is applicable to special type hepatic resection subgroups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Jiang-ming Chen | The Second Affiliated Hospital of Anhui Medical University | 15855518651 | 86 | chenjm10@126.com |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| BiClamp forceps | Device | liver transection during hepatectomy by BiClamp forceps |
|
| 90 days |
| Morbidity | 90 days |
| Biliary Leakage | Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems | 90 days |
| Duration of Postoperative Hospital Stay | Time from day of operation to day of discharge | 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 | 2 days |
| Total Bilirubin | serum total bilirubin on 3 postoperative day (umol/L) | 3 postoperative day |
| Gurusamy 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. |
| 22993104 | Result | Itoh 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. |
| 25925431 | Derived | Chen 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. |
| BiClamp Forceps Hepatectomy |
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. BiClamp forceps: liver transection during hepatectomy by BiClamp forceps |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Transection surface area | Mean | Standard Deviation | cm2 |
|
| Specimen weight | Mean | Standard Deviation | g |
|
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.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|
| Secondary | Liver Transection Time | liver transection time was calculated from the beginning to the end of the liver resection | Posted | Mean | Standard Deviation | min | an expected average of 40 minutes |
|
|
|
| Secondary | Mortality | Operative mortality was defined as any death resulting from a complication during surgery | Posted | Number | participants | 90 days |
|
|
|
| Secondary | Morbidity | Posted | Number | participants | 90 days |
|
|
|
| Secondary | Biliary Leakage | Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems | Posted | Number | participants | 90 days |
|
|
|
| Secondary | Duration of Postoperative Hospital Stay | Time from day of operation to day of discharge | Posted | Mean | Standard Deviation | days | an expected average of 12 days |
|
|
|
| Secondary | Number of Participants Requiring a Blood Transfusion | Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively | Posted | Number | participants | 2 days |
|
|
|
| Secondary | Total Bilirubin | serum total bilirubin on 3 postoperative day (umol/L) | Posted | Mean | Standard Deviation | umol/l | 3 postoperative day |
|
|
|
| 4 |
| 43 |
| 12 |
| 43 |
| EG001 | BiClamp Forceps Hepatectomy | 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. BiClamp forceps: liver transection during hepatectomy by BiClamp forceps | 2 | 43 | 12 | 43 |
|
| pleural effusions | General disorders | pleural effusions | Non-systematic Assessment |
|
| Liver failure | Hepatobiliary disorders | Liver failure | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | Wound infection | Non-systematic Assessment |
|
| Biliary leakage | Hepatobiliary disorders | Biliary leakage | Non-systematic Assessment |
|
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