Clinical trial NCT02617498: Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection
Official title: Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection of Living Donor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: End Stage Liver Disease
Keywords: living donor liver transplantation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: the amount of blood loss
timeFrame: 6 hours during operation
Secondary outcomes:
measure: operative time
timeFrame: minutes during operations
measure: number of ligation used,
timeFrame: hours during operations
measure: extent of necrosis at the cut surface
timeFrame: one week postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura University
name: Ayman El Nakeeb, MD
role: STUDY_DIRECTOR
References:
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. 2012 Jun;16(6):1181-8. doi: 10.1007/s11605-012-1851-4. Epub 2012 Feb 28.
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 J Gastroenterol. 2014 Oct 7;20(37):13607-14. doi: 10.3748/wjg.v20.i37.13607.
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):1393-401. doi: 10.1002/lt.23964.
citation: 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 randomized controlled trial. Liver Transpl. 2009 Jan;15(1):102-5. doi: 10.1002/lt.21658.
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 efficacy. Am J Surg. 2009 Feb;197(2):e25-7. doi: 10.1016/j.amjsurg.2008.01.019. Epub 2008 Jul 17.