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

Hepatic Neoplasms Clinical Trial

Official title:

Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method: A Prospective Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02213692
• Other study ID #: D2014-051
• Status: Terminated
• Phase: N/A
• First received: May 30, 2014
• Last updated: February 2, 2016
• Start date: May 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatic Neoplasms
• Liver Neoplasms

Locations

Country	Name	City	State
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hui-Chuan Sun

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	Amount of blood loss will be assayed during operation.	intraoperatively operation(an average of 3 hours)	Yes
Secondary	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)	No
Secondary	Hepatic hilar clamping time	Hepatic hilar clamping time (Pringle's method) will be recorded.	duration of clamping of hepatic hilar (an average of 30 minutes)	No
Secondary	Hospital stay	Time of hospital stay will be recorded.	dates from admission to discharge (an average of 8 days)	No
Secondary	Postoperative complications	Postoperative complications including bile leakage, bleeding, morbidity, injured Liver function will be recorded.	within 7 days after operation	Yes