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Stapler Hepatectomy for Elective Liver Resection

Clamp-Crushing vs. Stapler Hepatectomy for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH - A Randomized Controlled Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01049607
Acronym
CRUNSH
Enrollment
130
Registered
2010-01-14
Start date
2010-01-31
Completion date
2012-03-31
Last updated
2013-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Resection

Keywords

Patients undergoing hepatic resection

Brief summary

There is clinical uncertainty and ongoing discussion among liver surgeons regarding the optimal method of parenchymal transection in patients undergoing elective hepatic resection. While the clamp-crushing technique still represents the reference technique for routine liver resections, transection of liver parenchyma using vascular staplers may offer a new and safe technique potentially reducing intraoperative blood loss, operation time as well as peri-operative morbidity. As morbidity of patients undergoing hepatic resection remains high, approaches to lower peri-operative complications are urgently required. Due to the lack of evidence it has to be evaluated, if the technique of stapler hepatectomy decreases intraoperative blood loss as a highly relevant predictor of peri-operative complications, patients' hospital stay and finally health care expenditures. These advantages would favor stapler hepatectomy to be applied in routine liver resections. As RCTs are generally considered to generate the most valid scientific evidence on a treatment's effects, the present trial evaluates potential benefits of stapler hepatectomy in a randomized fashion.

Interventions

PROCEDUREClamp-Crush technique

The transectional line is marked and the liver capsule is cauterized. The liver parenchyma is then crushed stepwise using a regular Pèan clamp. Vessels and bile ducts are ligated or clipped. Vessels of less than 2mm diameter are coagulated with the irrigated bipolar forceps.

The transectional line is marked and the liver capsule is cauterized. For subsequent transection of the hepatic parenchyma, the liver tissue is fractured with a vascular clamp in a stepwise fashion and subsequently divided with endo GIA vascular staplers.

Sponsors

Nuh Rahbari
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for elective hepatic resection * Stapler hepatectomy and clamp-crushing feasible based on preoperative imaging * Age equal or greater than 18 years * Informed consent

Exclusion criteria

* Participation in concurrent intervention trials * Expected lack of compliance * Impaired mental state or language problems

Design outcomes

Primary

MeasureTime frame
Intraoperative blood loss2.5 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026