Evaluation Of Liver Resection Using Harmonic Scalpel Versus Cavitron Ultrasonic Surgical Aspirator (CUSA).

NCT07142876 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med-25-8-5MD
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation Of Liver Resection Using Harmonic Scalpel Versus Cavitron Ultrasonic Surgical Aspirator (CUSA) Introduction The mode of parenchymal transection in hepatic resection has been a topic of great debate for decades. Many resections have now evolved into laparoscopic , and robotic-assisted procedures to limit morbidity. Morbidity and mortality after hepatic resection has progressively improved over the years due to improved equipment, operative technique \[3\], and anesthetic management. Prior to 1980, mortality rates were reported to be in the 10-20% range with many deaths related to perioperative hemorrhage. Now perioperative mortality has dropped significantly to approximately 5%. The clamp-crush technique, first reported in 1974, has been used for decades and remains the standard means of parenchymal division for many surgeons. Control of intraoperative hemorrhage has been one of the principle technical problems in advancing liver surgery. Excess blood loss and intraoperative blood transfusions have been shown to be associated with increased perioperative mortality and morbidity including an increased rate of hepatocellular carcinoma recurrence . Transfusions are also associated with increased infections and with increased cost. Costs of blood transfusions were recently examined in surgical patients. Many devices are now available to surgeons for division of the liver parenchyma in both open and minimally invasive surgery including: the CUSA (Tyco Healthcare, Mansfield, MA), Harmonic Scalpel (Ethicon Endo-Surgery, Cincinnati, OH, USA), Ligasure (Valley Lab, Tyco Healthcare, Boulder, CO, USA), Tissue Link (Salient Surgical Technologies, Portsmouth, NH), water-jet dissection, radiofrequency, microwave assisted resection, vascular staplers, and others In this study, we looked at the TissueLink bipolar sealer device that was used in combination with the CUSA in group 1 termed the CUSA/TissueLink group, and the Harmonic Scalpel in the group 2 termed Harmonic Scalpel/TissueLink. The TissueLink uses radiofrequency energy focused near the end of the device for electrocautery and a low volume saline drip that produces ohmic heat causing precoagulation of hepatic parenchyma. The saline keeps the temperature at or below 100 C to avoid eshcar formation ultimately helping prevent delayed biliary leak and hemorrhage. The hemostatic effects of TissueLink are a result of its disruption of the collagen in blood vessels causing closing of the lumen . The CUSA, a commonly used device in hepatic resection, was used in combination with the TissueLink in this study. We previously described this combination of devices reporting a shorter length of hospital stay, decreased operative time, and decreased intraoperative blood transfusion . CUSA uses ultrasonic energy to fragment and aspirate parenchymal tissue. This exposes biliary as well as vascular structures that may then be closed in a variety of ways at the surgeon's discretion. It allows for a precise transection plane allowing preservation of normal hepatic tissue . The Harmonic Scalpel, used in this study in combination with the TissueLink, utilizes ultrasonic vibration of two blades causing destruction of hydrogen bonds. This disruption of hydrogen bonds causes protein denaturization coagulating small vessels of 3 mm diameter. The parenchyma is also cut when the blades move in a saw-like fashion In this study, we evaluated the safety and efficacy of two different techniques described above for the division of the hepatic parenchyma in order to improve perioperative outcomes.

Conditions

Liver Resection; Liver Tumours; Liver Transplant Disorder; Trauma Abdomen

Keywords

liver resection; CUSA; Cavitron Ultrasonic Surgical Aspirator; Harmonic

Outcome Measures

Primary Outcomes (3)

• Postoperative bile leakage

  Postoperative bile leakage was diagnosed once bile was detected from the wound or the drain or drained intra-abdominal collection with total bilirubin level in the fluid more than 3 times that in the serum.

  Day 14

• The liver resection time

  The liver resection time was defined as the duration from the beginning of parenchymal transection until the completion of transection with complete achievement of haemostasis from the liver cut surface.

  Day 1

• Blood loss

  Blood loss during parenchymal transection and immediately after hepatectomy until completion of the procedures was included and estimated by the volume of blood suctioned and subtraction of rinse fluids and/or weighting the swabs that were used during transection, (Every 1 mL of blood is equivalent to 1 g increase in the swab weight).

  Day 1

Secondary Outcomes (1)

• liver functions

  Day 14

Study Arms (2)

Liver resection with Cavitron Ultrasonic Surgical Settings Aspirator (CUSA)

ACTIVE COMPARATOR

In-group A Cavitron Ultrasonic Surgical Settings Aspirator (CUSA) with standard tip was used for parenchymal transection with the following Settings; 23 kHz, 70 Watt, and continuous irrigation at rate of 4-6 ml/min with normal saline and the vessel coagulation was performed by the bipolar sealer (Valleylab force FX electrosurgical generator, Medtronic, Minneapolis, USA), the power was used at 50 Watt coagulation.

Procedure: Liver resection Cavitron Ultrasonic Surgical Aspirator (CUSA)

Liver resection with the harmonic scalpel

ACTIVE COMPARATOR

In group B the harmonic scalpel (Ethicon EndoSurgery, Johnson \& Johnson, New Jersey, USA) was set at a high power, and blood vessels or bile ducts up to 3-4 mm in diameter were coagulated for 5-6 seconds.

Procedure: Liver resection with the harmonic scalpel

Interventions

Liver resection Cavitron Ultrasonic Surgical Aspirator (CUSA) PROCEDURE

In-group A Cavitron Ultrasonic Surgical Settings Aspirator (CUSA) with standard tip was used for parenchymal transection with the following Settings; 23 kHz, 70 Watt, and continuous irrigation at rate of 4-6 ml/min with normal saline and the vessel coagulation was performed by the bipolar sealer (Valleylab force FX electrosurgical generator, Medtronic, Minneapolis, USA), the power was used at 50 Watt coagulation.

Also known as: Group A

Liver resection with Cavitron Ultrasonic Surgical Settings Aspirator (CUSA)

Liver resection with the harmonic scalpel PROCEDURE

In group B the harmonic scalpel (Ethicon EndoSurgery, Johnson \& Johnson, New Jersey, USA) was set at a high power, and blood vessels or bile ducts up to 3-4 mm in diameter were coagulated for 5-6 seconds.

Also known as: Group B

Liver resection with the harmonic scalpel

Eligibility Criteria

• Age: 6 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients needing liver resection in normal liver and cirrhotic liver child-pough A and early B
• Age \> 6 and \< 70 years old
• One or two small (5 cm or less) hepatic lesions confined to the liver with no extra hepatic involvement
• Patients with -ve markers for viral hepatitis

You may not qualify if:

• patients with age \< 6 or \> 70 years old
• liver cirrhosis Child-pough C
• liver cell failure
• very large lesions including most of the liver tissue
• hepatic lesions with vascular invasion
• evidence of metastasis in cases with HCC
• patients with +ve markers for viral hepatitis

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Abdominal Injuries

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• AbdElaal A Prof. AbdElaal Ali Sleem, professor

  AbdElaal Ali Sleem

  STUDY CHAIR

Central Study Contacts

Mohamed Mahmoud Mohamed Hassanein, Assistant lecturer

CONTACT

+201099827891; mohamed_elzeer@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: prospective randomized comparative clinical trial study analyzing outcomes of liver resection by two different techniques CUSA or Harmonic scalpel .This will be a prospective comparative study at Sohag University Hospital and Assuit University Hospital, Egypt The study population was divided into two equal groups (25 per group) according to the method of liver transection: group A by CUSA and group B by harmonic scalpel (HS). Inclusion criteria patients needing liver resection in normal liver and cirrhotic liver child-pough A and early B with: Age \> 6 and \< 70 years old, One or two small (5 cm or less) hepatic lesions confined to the liver with no extra hepatic involvement, Patients with -ve markers for viral hepatitis. The exclusion criteria: patients with age \< 6 or \> 70 years old, liver cirrhosis Child-pough C, liver cell failure, very large lesions including most of the liver tissue, vascular invasion, evidence of metastasis in cases with HCC, positive hepatitis

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 27, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share