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Blood loss during liver resection significantly associates with short term operative outcome. The median blood loss during partial liver resection is 700-1200ml in high-volume centers. Conventional method (crush-clamp) has been a standard technique for liver transection. Technique advances related to liver transection have contributed to reduction in blood loss. Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use. A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased operative time, blood loss and transfusion requirement, and an increased incidence of postoperative bile leakage. However, no randomized study has compared the difference between liver resection using traditional technology and harmonic Scalpel. The objective of this prospective randomized study is to compare the safety and efficacy of liver resection using the harmonic scalpel device with the "crush-clamp" technique in respect to blood loss, liver transection time, hepatic hilum clamping time, hospital stay and postoperative complications.
Blood loss during liver resection significantly associates with short term operative outcome. The median blood loss during partial liver resection is 700-1200ml in high-volume centers. Conventional method (crush-clamp) has been a standard technique for liver transection. Technique advances related to liver transection have contributed to reduction in blood loss. Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use. A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased operative time, blood loss and transfusion requirement, and an increased incidence of postoperative bile leakage. However, no randomized study has compared the difference between liver resection using traditional technology and harmonic Scalpel. The objective of this prospective randomized study is to compare the safety and efficacy of liver resection using the harmonic scalpel device with the "crush-clamp" technique in respect to blood loss, liver transection time, hepatic hilum clamping time, hospital stay and postoperative complications. All patients submitted to liver resection are randomized into two groups: those submitted to liver resection with the use of "crush-clamp" technique. (group Α) and those with the use of the Harmonic Scalpel device (group Β).
Crush-clamping Method (group A) :Patients submitted to liver resection with the use of "crush-clamping" technique.
Device: Liver parenchymal is crushed by surgeon's fingers or basic surgical clamps to isolate small vessels and biliary radicals, and then divided by suture ligation, electrocautery, or vascular clips.
Harmonic Scalpel (group B) :Patients submitted to liver resection with the use of the Harmonic Scalpel device.Device: liver parenchymal transection is transected by harmonic scalpel, and small vessels and biliary radicals (<3mm) is also divided by harmonic scalpel. Vessels and biliary radicals (≥ 3mm) were divided by suture ligation, electrocautery, or vascular clips.
Primary Outcome Measures:
Blood loss during operation [an expected average of 3 hours] operation][Designated as safety issue: Yes] Postoperative complications including bile leakage, bleeding, morbidity, injured Liver function [Time Frame: participants will be followed for the duration of hospital stay, an expected average of 8 days] [Designated as safety issue: Yes]
Secondary Outcome Measures:
Transection time from Mark of the cutting edge to finish disposed of the cutting edge [Designated as safety issue: No] Hepatic hilar clamping time (Pringle's method) [the duration of clamping of hepatic hilar] [Designated as safety issue: No] Hospital stay [participants will be followed for the duration of hospital stay, an expected average of 8 days] [Designated as safety issue: No] Enrollment: 128 Study Start Date: June 2014 Study Completion Date: May 2015 Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Eligibility:
Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crush-clamping Method (group A) | Liver parenchymal is crushed by surgeon's fingers or basic surgical clamps to isolate small vessels and biliary radicals, and then divided by suture ligation, electrocautery, or vascular clips. | ||
| Harmonic Scalpel Method (group B) | Liver parenchymal transection is transected by harmonic scalpel, and small vessels and biliary radicals (<3mm) is also divided by harmonic scalpel. Vessels and biliary radicals (≥ 3mm) were divided by suture ligation, electrocautery, or vascular clips. |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | Amount of blood loss will be assayed during operation. | intraoperatively operation(an average of 3 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Transection time | Liver transection time from Mark of the cutting edge to finish disposed of the cutting edge will be recorded. | from Mark of the cutting edge to finish disposed of the cutting edge (an average of 1 hour) |
| Hepatic hilar clamping time |
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Inclusion Criteria:
Exclusion Criteria:
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Genders Eligible for Study: Both Accepts Healthy Volunteers: No
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| Name | Affiliation | Role |
|---|---|---|
| Hui Chuan Sun, Professor | Fudan University | Study Chair |
| Jia Fan, Professor | Fudan University | Principal Investigator |
| Jian Zhou, Professor | Fudan University | Principal Investigator |
| Shuang Jian Qiu, Professor | Fudan University | Principal Investigator |
| Guo Ming Shi, Asso. Prof. | Fudan University | Principal Investigator |
| Qing Hai Ye, Professor | Fudan University | Principal Investigator |
| Lu Wang, Professor | Fudan University | Principal Investigator |
| Xiao Wu Huang, Professor | Fudan University | Principal Investigator |
| Ning Ren, Professor | Fudan University | Principal Investigator |
| Jing Xian Yu, Nurse | Fudan University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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Hepatic hilar clamping time (Pringle's method) will be recorded.
| duration of clamping of hepatic hilar (an average of 30 minutes) |
| Hospital stay | Time of hospital stay will be recorded. | dates from admission to discharge (an average of 8 days) |
| Postoperative complications | Postoperative complications including bile leakage, bleeding, morbidity, injured Liver function will be recorded. | within 7 days after operation |
| Principal Investigator |
| Yang Xu, Asso. Prof. | Fudan University | Principal Investigator |
| Ying Hong Shi, Asso. Prof. | Fudan University | Principal Investigator |
| Xiao Ying Wang, Asso. Prof | Fudan University | Principal Investigator |
| Jian Sun, Asso. Prof. | Fudan University | Principal Investigator |
| Zheng Wang, Asso. Prof. | Fudan University | Principal Investigator |
| Yong Sheng Xiao, Asso. Prof. | Fudan University | Principal Investigator |
| Pei Chen, Asso. Prof. | Fudan University | Principal Investigator |
| Cheng Huang, Asso. Prof. | Fudan University | Principal Investigator |
| Ying Hao Shen, Asso. Prof. | Fudan University | Principal Investigator |
| D008107 |
| Liver Diseases |