Liver ResectionCRUNSHIINCT01858987
Stapler vs. LigaSure in Elective Hepatic Resection
A study testing Stapler hepatectomy, LigaSure hepatectomy and Ligasure in people with Liver Resection, run by Heidelberg University at 1 site in Germany.
Trial summary
The optimal technique of parenchymal transection in liver surgery has remained a matter of controversial debate among hepatobiliary surgeons. The optimal technique should enable secure sealing of the vascular and biliary structures that results in low intraoperative blood loss as well as low postoperative complication… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Resection
- What is being tested?
- Stapler hepatectomy, LigaSure hepatectomy and Ligasure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteGermany
- Study dates
- 2 Nov 2011to 14 Aug 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective hepatic resection
- Parenchymal transection by vascular stapler and LigaSure feasible
- Age equal or greater than 18 years
- Informed consent
Who cannot join
- Extrahepatic resection required based on preoperative imaging
- Participation in concurrent surgical intervention trials
- Expected lack of compliance
- Impaired mental state or language problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stapler vs. LigaSure for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH II - A Randomized Controlled Trial
The optimal technique of parenchymal transection in liver surgery has remained a matter of controversial debate among hepatobiliary surgeons. The optimal technique should enable secure sealing of the vascular and biliary structures that results in low intraoperative blood loss as well as low postoperative complication rates. Although numerous devices have been introduced and are used widely, high-level evidence, randomized controlled trials, that evaluate efficacy and safety of these devices are scarce. In the present randomized controlled trial two techniques of hepatic resection using vascular staplers and the LigaSure vessel sealing device are compared. While the primary endpoint is intraoperative blood loss a set of general and surgical variables will be analyzed to evaluate efficacy and safety of both methods.
- Conditions
- Liver Resection
- Being tested
- Stapler hepatectomy, LigaSure hepatectomy, Ligasure, vascular staple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapler hepatectomyProcedure or surgery
Liver resection using vascular stapler for transection of the parenchyma
LigaSure hepatectomyProcedure or surgery
Liver resection using LigaSure for transection of the parenchyma
LigasureDevice
vascular stapleOther
| Study group | Role | What they receive |
|---|---|---|
| Stapler hepatectomy | Active comparator | Liver resection using vascular stapler for transection of the parenchyma Receives: Procedure: Stapler hepatectomy; Other: vascular staple |
| LigaSure Hepatectomy | Experimental | Liver resection using LigaSure for transection of the parenchyma Receives: Procedure: LigaSure hepatectomy; Device: Ligasure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Blood loss
Intraoperative blood loss represents the primary efficacy endpoint of the CRUNSH II-Trial. To obtain a more precise estimate for the individual patient patient's individual transection area will be considered as a continuous covariate in the analysis of covariance (ANOVA). The transection area will be assessed using an imprint of the resected specimen on a paper sheet with a known density of 80 mg/m2. The marked paper area will be cut and weight to calculate the transection area. Intraoperative blood loss will be measured according to the blood collected in the suction containers. Spilling water and ascites will be subtracted. Furthermore, swabs will be squeezed and their content will also be sucked and added to the fluid collected in the suction containers. Central venous pressure will be lowered below 5 cmH2O for the transection period.
Measured: Beginning to end of surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study start2 Nov 2011
- Primary completion17 Jul 2014
- Study completion14 Aug 2014
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 Liver ResectionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuh Rahbari, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858987
- Sponsor's protocol ID
- NNR-08
- Acronym
- CRUNSHII
- Status last verified
- Oct 2017
- First submitted
- 16 May 2013
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fritzmann J, Kirchberg J, Sturm D, Ulrich AB, Knebel P, Mehrabi A, Buchler MW, Weitz J, Reissfelder C, Rahbari NN. Randomized clinical trial of stapler hepatectomy versus LigaSure transection in elective hepatic resection. Br J Surg. 2018 Aug;105(9):1119-1127. doi: 10.1002/bjs.10902.
PubMed 30069876
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stapler vs. LigaSure for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH II - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01858987
- Acronym / sponsor ID
- CRUNSHII / NNR-08
- Conditions
- Liver Resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 2 Nov 2011 (actual)
- Primary completion
- 17 Jul 2014 (actual)
- Study completion
- 14 Aug 2014 (actual)
- First posted
- 21 May 2013 (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 optimal technique of parenchymal transection in liver surgery has remained a matter of controversial debate among hepatobiliary surgeons. The optimal technique should enable secure sealing of the vascular and biliary structures that results in low intraoperative blood loss as well as low postoperative complication rates. Although numerous devices have been introduced and are used widely, high-level evidence, randomized controlled trials, that evaluate efficacy and safety of these devices are scarce. In the present randomized controlled trial two techniques of hepatic resection using vascular staplers and the LigaSure vessel sealing device are compared. While the primary endpoint is intraoperative blood loss a set of general and surgical variables will be analyzed to evaluate efficacy and safety of both methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stapler hepatectomy | Active comparator | Procedure: Stapler hepatectomy, Other: vascular stapleLiver resection using vascular stapler for transection of the parenchyma |
| LigaSure Hepatectomy | Experimental | Procedure: LigaSure hepatectomy, Device: LigasureLiver resection using LigaSure for transection of the parenchyma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective hepatic resection
- Parenchymal transection by vascular stapler and LigaSure feasible
- Age equal or greater than 18 years
- Informed consent
Key exclusion criteria (4 listed)
- Extrahepatic resection required based on preoperative imaging
- Participation in concurrent surgical intervention trials
- Expected lack of compliance
- Impaired mental state or language problems
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 |
|---|---|---|
| Stapler hepatectomyLiver resection using vascular stapler for transection of the parenchyma | Procedure or surgery | Stapler hepatectomy |
| LigaSure hepatectomyLiver resection using LigaSure for transection of the parenchyma | Procedure or surgery | LigaSure Hepatectomy |
| Ligasure | Device | LigaSure Hepatectomy |
| vascular staple | Other | Stapler hepatectomy |
Primary outcome
Intraoperative Blood loss
Time frame: Beginning to end of surgical procedure
Intraoperative blood loss represents the primary efficacy endpoint of the CRUNSH II-Trial. To obtain a more precise estimate for the individual patient patient's individual transection area will be considered as a continuous covariate in the analysis of covariance (ANOVA). The transection area will be assessed using an imprint of the resected specimen on a paper sheet with a known density of 80 mg/m2. The marked paper area will be cut and weight to calculate the transection area. Intraoperative blood loss will be measured according to the blood collected in the suction containers. Spilling water and ascites will be subtracted. Furthermore, swabs will be squeezed and their content will also be sucked and added to the fluid collected in the suction containers. Central venous pressure will be lowered below 5 cmH2O for the transection period.
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 9 Oct 2017.
- Derived from this study: PubMed 30069876Fritzmann J, Kirchberg J, Sturm D, Ulrich AB, Knebel P, Mehrabi A, Buchler MW, Weitz J, Reissfelder C, Rahbari NN. Randomized clinical trial of stapler hepatectomy versus LigaSure transection in elective hepatic resection. Br J Surg. 2018 Aug;105(9):1119-1127. doi: 10.1002/bjs.10902.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stapler hepatectomy, LigaSure hepatectomy and Ligasure in people with Liver Resection, run by Heidelberg University at 1 site in Germany.
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 4 inclusion and 4 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 9 Oct 2017. 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 Germany. 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.
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?
Intraoperative Blood loss (time frame: Beginning to end of surgical procedure). 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 NCT01858987, 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 9 Oct 2017.