Transplant Trial Watch

Clamp-Crush Technique Versus Harmonic Scalpel for Hepatic Parenchymal Transection in Living Donor Hepatectomy: a Randomized Controlled Trial.

Sultan, A. M., Shehta, A. et al. (2019).

J Gastrointest Surg; [record in progress].


Aims
The aim of this study was to compare the safety, efficacy, and outcome of clamp-crush technique versus harmonic scalpel as a method of parenchymal transection in living-donor hepatectomy.

Interventions
Cases were randomised into two groups: group (A) harmonic scalpel group and group (B) Clamp-crush group.

Participants
72 patients undergoing right hemihepatectomy for adult living donor liver transplantation (LDLT).

Outcomes
Primary outcomes of the study included blood loss (during parenchymal resection and total operative blood loss) and blood transfusion requirements. Secondary outcomes included parenchymal transection time, total operating time, necrosis at the cut margin of the remnant liver by pathological examination, perioperative morbidities (bleeding and bile leakage), postoperative biochemical markers (leucocytic count, platelets, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), international normalized ration (INR), CRP), and hospital stay.

Follow-up
N/A

CET Conclusions
This study randomised living liver donors to either harmonic scalpel or clamp-crush technique for parenchymal transection, the most invasive step of the right hepatectomy procedure. Randomisation was by “closed envelope” which, whilst we have to assume is random may not result in completely robust allocation concealment. The primary outcomes were blood loss and blood transfusion requirements, but no power calculation is provided. It is unclear if the analysis presented is per protocol or intention to treat. No significant difference was found in operative blood loss or blood transfusion requirement, however the overall range of operative blood loss is very wide (from 50 to 1750ml). Operative time was significantly longer with clamp-crush technique (440 minutes average versus 360 minutes average). The authors describe that more unexpected bleeding events were found with harmonic scalpel, but this is not defined (22% versus 3%). There was a larger margin of necrotic tissue at the cut edge with harmonic scalpel than with clamp-crush technique (0.5mm versus 0.3mm) but this does not seem clinically relevant. The study may be underpowered for clinically relevant differences in the primary outcomes and was not set up as either a superiority or non-inferiority trial. As with all surgical interventions, it can be difficult to assess the impact of a technique alone when the familiarity of the surgeon with the technique is of major importance.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT02853981

Funding source
Not reported