Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02213692
Other study ID # D2014-051
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT01906021 - Study of New Software Used During Ablations N/A
Completed NCT02784353 - Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy N/A
Terminated NCT00669136 - Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma Phase 1
Terminated NCT02866344 - Resection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases N/A
Recruiting NCT02246634 - Screening for Synchronous Metastases in Colorectal Cancer With DW-MRI (SERENADE) N/A
Completed NCT00307866 - Identification of Hepatic Lesions Phase 3