Clinical trial NCT02213692: Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method
Official title: Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method: A Prospective Randomized Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatic Neoplasms
Keywords: Liver Resection
Harmonic Scalpel
Crush-clamping
A Prospective Randomized Study
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-08-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Genders Eligible for Study: Both Accepts Healthy Volunteers: No

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.

Detailed description: 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:

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 international normalized ratio (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 \> 13seconds;
3. Blood platelets count (BPC) \< 60\*109
4. Moderate and severe of esophageal varices detected by CT or MRI
5. Diameter of portal vein \> 14mm (color ultrasound)

Eligibility 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)

Primary outcomes:
measure: Blood loss
timeFrame: intraoperatively operation（an average of 3 hours)
Secondary outcomes:
measure: Transection time
timeFrame: from Mark of the cutting edge to finish disposed of the cutting edge (an average of 1 hour)
measure: Hepatic hilar clamping time
timeFrame: duration of clamping of hepatic hilar (an average of 30 minutes)
measure: Hospital stay
timeFrame: dates from admission to discharge (an average of 8 days)
measure: Postoperative complications
timeFrame: within 7 days after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Hui Chuan Sun, Professor
role: STUDY_CHAIR
affiliation: Fudan University
name: Jia Fan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Jian Zhou, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Shuang Jian Qiu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Guo Ming Shi, Asso. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Qing Hai Ye, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Lu Wang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Xiao Wu Huang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Ning Ren, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Jing Xian Yu, Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Yang Xu, Asso. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Ying Hong Shi, Asso. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Xiao Ying Wang, Asso. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Jian Sun, Asso. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Zheng Wang, Asso. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Yong Sheng Xiao, Asso. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Pei Chen, Asso. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Cheng Huang, Asso. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Ying Hao Shen, Asso. Prof.
role: PRINCIPAL_INVESTIGATOR
References: