End Stage Liver DiseaseEarly Phase 1LDLTNCT02617498
Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection
A Early Phase 1 study testing harmonic scalpel and spray mode diathermy in people with End Stage Liver Disease, run by Mansoura University.
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. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- End Stage Liver Disease
- What is being tested?
- harmonic scalpel and spray mode diathermy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Nov 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Consecutive patients, who were treated for end stage liver cirrhosis by LDLT
Who cannot join
- -
About this study
Official title: Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection of Living Donor.
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).
Read the 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.
- Conditions
- End Stage Liver Disease
- Being tested
- harmonic scalpel, spray mode diathermy
- Keywords
- living donor liver transplantation
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
harmonic scalpelDevice
Also called Group A
parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler.
spray mode diathermyDevice
Also called Group B
parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: spray mode diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of blood loss
the amount of blood loss
Measured: 6 hours during operation
Secondary outcomes (3)
operative time
Measured: minutes during operations
number of ligation used,
Measured: hours during operations
extent of necrosis at the cut surface
Measured: one week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for End Stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman El Nakeeb, Mansoura University
- Investigators
- Ayman El Nakeeb, MD, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617498
- Sponsor's protocol ID
- hepatic transection
- Acronym
- LDLT
- Status last verified
- Mar 2016
- First submitted
- 20 Nov 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22370735Wahab 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.
PubMed 25309092Sultan 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.
PubMed 25060964El 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.
PubMed 19109835Takatsuki 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.
PubMed 18639230
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection of Living Donor.
- ClinicalTrials.gov ID
- NCT02617498
- Acronym / sponsor ID
- LDLT / hepatic transection
- Conditions
- End Stage Liver Disease
- Keywords
- living donor liver transplantation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| harmonic scalpel | Active comparator | Device: harmonic scalpelparenchymal 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. |
| spray mode diathermy | Active comparator | Device: spray mode diathermyparenchymal 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. |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Consecutive patients, who were treated for end stage liver cirrhosis by LDLT
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| harmonic scalpelAlso: Group Aparenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler. | Device | harmonic scalpel |
| spray mode diathermyAlso: Group Bparenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler. | Device | spray mode diathermy |
Primary outcome
the amount of blood loss
Time frame: 6 hours during operation
the amount of blood loss
3 secondary outcomes
operative time
Time frame: minutes during operations
number of ligation used,
Time frame: hours during operations
extent of necrosis at the cut surface
Time frame: one week postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Results publication: PubMed 22370735Salah 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.
- Results publication: PubMed 25309092Wahab 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.
- Results publication: PubMed 25060964Sultan 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.
- Results publication: PubMed 19109835El 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.
- Results publication: PubMed 18639230Takatsuki 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.
- mansoura universityLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for End Stage Liver Disease
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman El Nakeeb, MD study director
Mansoura University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing harmonic scalpel and spray mode diathermy in people with End Stage Liver Disease, run by Mansoura University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the amount of blood loss (time frame: 6 hours during operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02617498, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.