Stapler Hepatectomy for Elective Liver Resection

NCT ID: NCT01049607

Last Updated: 2013-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-03-31

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.

Conditions

Hepatic Resection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Clamp-Crush technique

Group Type: ACTIVE_COMPARATOR

Clamp-Crush technique

Intervention Type: PROCEDURE

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.

Stapler hepatectomy

Group Type: EXPERIMENTAL

Stapler hepatectomy

Intervention Type: PROCEDURE

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.

Interventions

Clamp-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.

Intervention Type: PROCEDURE

Stapler hepatectomy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuh Rahbari

OTHER

Sponsor Role: lead

Responsible Party

Nuh Rahbari

M.D. Resident

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jürgen Weitz, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Heidelberg, Baden-Wurttemberg, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 24402888 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21888669 (View on PubMed)

Other Identifiers

NNR-03

Identifier Type: -

Identifier Source: org_study_id