Sponsor study identifier
observational
120
1 country
1
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
May 30, 2014
Actual (reported)August 11, 2014
Actual (reported)October 2015
Actual (reported)October 2015
Actual (reported)Blood loss
Amount of blood loss will be assayed during operation.
intraoperatively operation(an average of 3 hours)
Transection time
from Mark of the cutting edge to finish disposed of the cutting edge (an average of 1 hour)
Hepatic hilar clamping time
duration of clamping of hepatic hilar (an average of 30 minutes)
Hospital stay
dates from admission to discharge (an average of 8 days)
Postoperative complications
within 7 days after operation
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.
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.
Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Hui Chuan Sun, Professor
Fudan University
Jia Fan, Professor
Fudan University
Jian Zhou, Professor
Fudan University
Shuang Jian Qiu, Professor
Fudan University
120 participants (actual enrollment reported by the registry).
First Submitted
May 30, 2014
First Posted
August 11, 2014
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Study Evaluating the Efficacy and Safety With CAR-T for Liver Cancer
Contact the study team to confirm eligibility.
Guo Ming Shi, Asso. Prof.
Fudan University
Qing Hai Ye, Professor
Fudan University
Lu Wang, Professor
Fudan University
Xiao Wu Huang, Professor
Fudan University
Ning Ren, Professor
Fudan University
Jing Xian Yu, Nurse
Fudan University
Yang Xu, Asso. Prof.
Fudan University
Ying Hong Shi, Asso. Prof.
Fudan University
Xiao Ying Wang, Asso. Prof
Fudan University
Jian Sun, Asso. Prof.
Fudan University
Zheng Wang, Asso. Prof.
Fudan University
Yong Sheng Xiao, Asso. Prof.
Fudan University
Pei Chen, Asso. Prof.
Fudan University
Cheng Huang, Asso. Prof.
Fudan University
Ying Hao Shen, Asso. Prof.
Fudan University
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)Last Updated
February 4, 2016
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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