Hepatic TransplantationPhase 2/3KK_HSNCT02853981
Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy
A Phase 2/3 study testing Harmonic scalpel and Kelly clamp crush technique in people with Hepatic Transplantation, run by Mansoura University at 1 site in Egypt.
Trial summary
The purpose of this study is to determine whether clamp-crush technique for liver parenchymal transection is as safe as Harmonic scalpel device. outcomes will include: perioperative mortality, surgery-related complications, blood loss, amount of blood loss during hepatectomy, operating time, transection speed, markers… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hepatic Transplantation
- What is being tested?
- Harmonic scalpel and Kelly clamp crush technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Sep 2016
- Phase
- Phase 2/3
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Liver right lobe donors
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Gastro-enterolgy surgical center, Mansoura University
Al Mansurah, Al-Dakahleia, 35516
About this study
Official title: Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy. A Single Blinded Randomized Controlled Trial
The purpose of this study is to determine whether clamp-crush technique for liver parenchymal transection is as safe as Harmonic scalpel device. outcomes will include: perioperative mortality, surgery-related complications, blood loss, amount of blood loss during hepatectomy, operating time, transection speed, markers of liver parenchymal injury and hospital stay.
- Conditions
- Hepatic Transplantation
- Being tested
- Harmonic scalpel, Kelly clamp crush technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic scalpelDevice
a method for liver parenchymal transection
Kelly clamp crush techniqueDevice
a method for liver parenchymal transection
| Study group | Role | What they receive |
|---|---|---|
| Harmonic scalpel group | Active comparator | group of donors whom will undergo liver transection using harmonic scalpel. Receives: Device: Harmonic scalpel |
| clamp-crush group | Active comparator | group of donors whom will undergo liver transection using Kelly clamp. Receives: Device: Kelly clamp crush technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss during hepatectomy
bleeding during transection phase will be calculated in mL. based on the blood in the sucker machine and the surgical towels
Measured: intraoperative
Secondary outcomes (2)
transection speed
the transection speed will be calculated in minutes based on the relation between the transecition time divided by the surface area of the raw area of the graft measured on the backtable.
Measured: intraoperative
liver pathology from the cut margin
the area of necrosis will be measured in millimeters by the pathologist
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic TransplantationStudies 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mohammad Ahmad Sultan, Mansoura University
- Investigators
- Ahmad M Sultan, MD, Study director, Assistant prof of general surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853981
- Sponsor's protocol ID
- GEC_LTx_Surg_216
- Acronym
- KK_HS
- Status last verified
- Jan 2018
- First submitted
- 11 Mar 2016
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Sultan AM, Shehta A, Salah T, Elshoubary M, Elghawalby AN, Said R, Elmorshedi M, Marwan A, Shiha U, Fathy O, Wahab MA. Clamp-Crush Technique Versus Harmonic Scalpel for Hepatic Parenchymal Transection in Living Donor Hepatectomy: a Randomized Controlled Trial. J Gastrointest Surg. 2019 Aug;23(8):1568-1577. doi: 10.1007/s11605-019-04103-5. Epub 2019 Jan 22.
PubMed 30671805
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy. A Single Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02853981
- Acronym / sponsor ID
- KK_HS / GEC_LTx_Surg_216
- Conditions
- Hepatic Transplantation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Aug 2016 (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.
The purpose of this study is to determine whether clamp-crush technique for liver parenchymal transection is as safe as Harmonic scalpel device. outcomes will include: perioperative mortality, surgery-related complications, blood loss, amount of blood loss during hepatectomy, operating time, transection speed, markers of liver parenchymal injury and hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harmonic scalpel group | Active comparator | Device: Harmonic scalpelgroup of donors whom will undergo liver transection using harmonic scalpel. |
| clamp-crush group | Active comparator | Device: Kelly clamp crush techniquegroup of donors whom will undergo liver transection using Kelly clamp. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Liver right lobe donors
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 scalpela method for liver parenchymal transection | Device | Harmonic scalpel group |
| Kelly clamp crush techniquea method for liver parenchymal transection | Device | clamp-crush group |
Primary outcome
blood loss during hepatectomy
Time frame: intraoperative
bleeding during transection phase will be calculated in mL. based on the blood in the sucker machine and the surgical towels
2 secondary outcomes
transection speed
Time frame: intraoperative
liver pathology from the cut margin
Time frame: intraoperative
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 19 Jan 2018.
- Derived from this study: PubMed 30671805Sultan AM, Shehta A, Salah T, Elshoubary M, Elghawalby AN, Said R, Elmorshedi M, Marwan A, Shiha U, Fathy O, Wahab MA. Clamp-Crush Technique Versus Harmonic Scalpel for Hepatic Parenchymal Transection in Living Donor Hepatectomy: a Randomized Controlled Trial. J Gastrointest Surg. 2019 Aug;23(8):1568-1577. doi: 10.1007/s11605-019-04103-5. Epub 2019 Jan 22.
- Individual participant dataSharing planned: Undecided
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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.
Ahmad M Sultan, MD study director
Assistant prof of general surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Harmonic scalpel and Kelly clamp crush technique in people with Hepatic Transplantation, run by Mansoura University at 1 site in Egypt.
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 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
blood loss during hepatectomy (time frame: intraoperative). 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 NCT02853981, which also lists 1 linked publication.
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 19 Jan 2018.