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Clinical Trials/NCT01049607
NCT01049607CompletedPhase 3

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

Nuh Rahbari1 site in 1 country130 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
130
Locations
1
Primary Endpoint
Intraoperative blood loss

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Clamp-Crush technique

Active Comparator

Intervention: Clamp-Crush technique (Procedure)

Stapler hepatectomy

Experimental

Intervention: Stapler hepatectomy (Procedure)

Outcomes

Primary Outcomes

Intraoperative blood loss

Time Frame: 2.5 hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Nuh Rahbari
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Nuh Rahbari

M.D. Resident

Heidelberg University

Study Sites (1)

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