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Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method

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ClinicalTrials.gov Identifier: NCT02213692
Recruitment Status : Terminated
First Posted : August 11, 2014
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Hui-Chuan Sun, Fudan University

Brief Summary:
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.

Condition or disease
Hepatic Neoplasms

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method: A Prospective Randomized Study
Study Start Date : May 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Group/Cohort
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.



Primary Outcome Measures :
  1. Blood loss [ Time Frame: intraoperatively operation(an average of 3 hours) ]
    Amount of blood loss will be assayed during operation.


Secondary Outcome Measures :
  1. Transection time [ Time Frame: from Mark of the cutting edge to finish disposed of the cutting edge (an average of 1 hour) ]
    Liver transection time from Mark of the cutting edge to finish disposed of the cutting edge will be recorded.

  2. Hepatic hilar clamping time [ Time Frame: duration of clamping of hepatic hilar (an average of 30 minutes) ]
    Hepatic hilar clamping time (Pringle's method) will be recorded.

  3. Hospital stay [ Time Frame: dates from admission to discharge (an average of 8 days) ]
    Time of hospital stay will be recorded.

  4. Postoperative complications [ Time Frame: within 7 days after operation ]
    Postoperative complications including bile leakage, bleeding, morbidity, injured Liver function will be recorded.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  1. Age ≥18y, and ≤80y;
  2. No history of liver resection and radiotherapy
  3. Liver function: Child A with a normal prothrombin time (<13 seconds) and INR (1.15);
  4. Extent of resection ≥2 segment or diameter of tumor (single nodule) ≥ 8cm or cumulative diameter of tumor (multiple nodule) ≥ 8cm; Eligible patients will be stratified by resection in left lobe or right lobe.
  5. No tumor thrombosis in main trunk or right and left branch of portal vein or major hepatic vein.

Exclusion Criteria:

  1. Recurrent liver tumor; or simultaneous resection of other organs except gallbladder
  2. Prothrombin time > 13S;
  3. Blood platelets count (BPC) < 60x109
  4. Moderate and severe of esophageal varices detected by CT or MRI
  5. Diameter of portal vein > 14mm (color ultrasound)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213692


Locations
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China, Shanghai
Zhongshan Hospital of Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Hui-Chuan Sun
Investigators
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Study Chair: Hui Chuan Sun, Professor Fudan University
Principal Investigator: 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
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

Additional Information:

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Responsible Party: Hui-Chuan Sun, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02213692     History of Changes
Other Study ID Numbers: D2014-051
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Keywords provided by Hui-Chuan Sun, Fudan University:
Liver Resection
Harmonic Scalpel
Crush-clamping
A Prospective Randomized Study
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics