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

NCT02213692 | Terminated DMC

• 1 other identifier: D2014-051
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Neoplasms

Keywords

Liver Resection; Harmonic Scalpel; Crush-clamping; A Prospective Randomized Study

Outcome Measures

Primary Outcomes (1)

• Blood loss

  Amount of blood loss will be assayed during operation.

  intraoperatively operation（an average of 3 hours)

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Genders Eligible for Study: Both Accepts Healthy Volunteers: No

You may qualify if:

• Age ≥18y, and ≤80y;
• No history of liver resection and radiotherapy
• Liver function: Child A with a normal prothrombin time (\<13 seconds) and INR (1.15);
• 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.
• No tumor thrombosis in main trunk or right and left branch of portal vein or major hepatic vein.

You may not qualify if:

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

Sponsors & Collaborators

• Hui-Chuan Sun: lead

Study Sites (1)

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• 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

  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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: August 11, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

CN (1)