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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01049607
Other study ID # NNR-03
Secondary ID
Status Completed
Phase Phase 3
First received January 13, 2010
Last updated May 16, 2013
Start date January 2010
Est. completion date March 2012

Study information

Verified date May 2013
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date March 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
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.
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.

Locations

Country Name City State
Germany Department of General, Visceral and Transplantation Surgery, University of Heidelberg Heidelberg BW

Sponsors (1)

Lead Sponsor Collaborator
Nuh Rahbari

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative blood loss 2.5 hours Yes
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