Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection

End Stage Liver Disease Clinical Trial

— LDLT  

Official title:

Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection of Living Donor.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617498
• Other study ID #: hepatic transection
• Status: Completed
• Phase: Phase 0
• First received: November 20, 2015
• Last updated: March 21, 2016
• Start date: April 2013
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in this a prospective study.Patients enrolled in the study divided into two groups according to the day of surgery. The study population was divided into two groups; group (A) Parenchymal liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver transection was performed by spray diathermy (SD).

Description:

Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in this a prospective study.Patients enrolled in the study divided into two groups according to the day of surgery. The study population was divided into two groups; group (A) Parenchymal liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver transection was performed by spray diathermy (SD).

Donors and recipient were followed up after hospital discharge with laboratory investigation, abdominal ultrasound, MRCP in selected cases every month for the first month, then every 6 months and then every year postoperatively. Follow up visits included clinical examination, laboratory investigation, doses of immunosuppressive, radiological examination, and doppler US.

The primary outcome was the amount of blood loss during transection. Secondary outcomes were operative time, time of transection, speed of transection/minutes , number of ligation used, degree of postoperative injury which assessed by daily liver function, WBC, C reactive protein, pathological changes at the cut surface, postoperative morbidity (including biliary leakage, collection), cost and hospital stay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 50 Years

Eligibility

Inclusion Criteria:

Consecutive patients, who were treated for end stage liver cirrhosis by LDLT

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Diseases

Intervention

Device:
• harmonic scalpel
parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler.
• spray mode diathermy
parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

References & Publications (5)

El Moghazy WM, Hedaya MS, Kaido T, Egawa H, Uemoto S, Takada Y. Two different methods for donor hepatic transection: cavitron ultrasonic surgical aspirator with bipolar cautery versus cavitron ultrasonic surgical aspirator with radiofrequency coagulator-A — View Citation

Salah T, Sultan AM, Fathy OM, Elshobary MM, Elghawalby NA, Sultan A, Yassen AM, Elsarraf WM, Elmorshedi M, Elsaadany MF, Shiha UA, Wahab MA. Outcome of right hepatectomy for living liver donors: a single Egyptian center experience. J Gastrointest Surg. 20 — View Citation

Sultan AM, Salah T, Elshobary MM, Fathy OM, Elghawalby AN, Yassen AM, Elmorshedy MA, Elsadany MF, Shiha UA, Wahab MA. Biliary complications in living donor right hepatectomy are affected by the method of bile duct division. Liver Transpl. 2014 Nov;20(11): — View Citation

Takatsuki M, Eguchi S, Yamanouchi K, Tokai H, Hidaka M, Soyama A, Miyazaki K, Hamasaki K, Tajima Y, Kanematsu T. Two-surgeon technique using saline-linked electric cautery and ultrasonic surgical aspirator in living donor hepatectomy: its safety and effic — View Citation

Wahab MA, Hamed H, Salah T, Elsarraf W, Elshobary M, Sultan AM, Shehta A, Fathy O, Ezzat H, Yassen A, Elmorshedi M, Elsaadany M, Shiha U. Problem of living liver donation in the absence of deceased liver transplantation program: Mansoura experience. World — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the amount of blood loss	the amount of blood loss	6 hours during operation	Yes
Secondary	operative time		minutes during operations	Yes
Secondary	number of ligation used,		hours during operations	Yes
Secondary	extent of necrosis at the cut surface		one week postoperative	Yes

External Links

•   mansoura university