NCT01049607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 17, 2013

Status Verified

May 1, 2013

Enrollment Period

1.7 years

First QC Date

January 13, 2010

Last Update Submit

May 16, 2013

Conditions

Hepatic Resection

Keywords

Patients undergoing hepatic resection

Outcome Measures

Primary Outcomes (1)

  • Intraoperative blood loss

    2.5 hours

Study Arms (2)

Clamp-Crush technique

ACTIVE COMPARATOR
Procedure: Clamp-Crush technique

Stapler hepatectomy

EXPERIMENTAL
Procedure: Stapler hepatectomy

Interventions

Clamp-Crush techniquePROCEDURE

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.

Clamp-Crush technique
Stapler hepatectomyPROCEDURE

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.

Stapler hepatectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (2)

  • Rahbari NN, Elbers H, Koch M, Vogler P, Striebel F, Bruckner T, Mehrabi A, Schemmer P, Buchler MW, Weitz J. Randomized clinical trial of stapler versus clamp-crushing transection in elective liver resection. Br J Surg. 2014 Feb;101(3):200-7. doi: 10.1002/bjs.9387. Epub 2014 Jan 8.

    PMID: 24402888DERIVED

  • Rahbari NN, Elbers H, Koch M, Bruckner T, Vogler P, Striebel F, Schemmer P, Mehrabi A, Buchler MW, Weitz J. Clamp-crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH)--a randomized controlled trial (NCT01049607). BMC Surg. 2011 Sep 4;11:22. doi: 10.1186/1471-2482-11-22.

    PMID: 21888669DERIVED

Study Officials

  • Jürgen Weitz, MD, MSc

    Department of General, Visceral and Transplantation Surgery, University of Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D. Resident

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

January 1, 2010

Primary Completion

October 1, 2011

Study Completion

March 1, 2012

Last Updated

May 17, 2013

Record last verified: 2013-05

Locations

DE(1)