NCT02617498

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2013

Typical duration for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

November 20, 2015

Last Update Submit

March 21, 2016

Conditions

End Stage Liver Disease

Keywords

living donor liver transplantation

Outcome Measures

Primary Outcomes (1)

  • the amount of blood loss

    the amount of blood loss

    6 hours during operation

Secondary Outcomes (3)

  • operative time

    minutes during operations

  • number of ligation used,

    hours during operations

  • extent of necrosis at the cut surface

    one week postoperative

Study Arms (2)

harmonic scalpel

ACTIVE COMPARATOR

parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler. The clearly exposed vessels were ligated by 5/0 proline or clipped according to their size.

Device: harmonic scalpel

spray mode diathermy

ACTIVE COMPARATOR

parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler. The clearly exposed vessels were ligated by 5/0 proline or clipped according to their size.

Device: spray mode diathermy

Interventions

harmonic scalpelDEVICE

parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler.

Also known as: Group A
harmonic scalpel
spray mode diathermyDEVICE

parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler.

Also known as: Group B
spray mode diathermy

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 22370735RESULT

  • 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.

    PMID: 25309092RESULT

  • 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.

    PMID: 25060964RESULT

  • 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.

    PMID: 19109835RESULT

  • 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.

    PMID: 18639230RESULT

Related Links

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Ayman El Nakeeb, MD

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 20, 2015

First Posted

December 1, 2015

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Study Completion

November 1, 2015

Last Updated

March 22, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share