A Systematic Review of Minimally Invasive Trans-thoracic Liver Resection to Examine Intervention Description, Governance, and Outcome Reporting of an Innovative Technique

Abstract

IntroductionThe number of laparoscopic liver resections undertaken has increased. However, lesions located postero-superiorly are difficult to access. This may be overcome by the novel use of transthoracic port(s). Methods for the safe and transparent introduction of new and modified surgical procedures are limited and a summary of these issues, for minimally invasive trans thoracic liver resections (MITTLR), is lacking.This study aims to understand and summarize technique description, governance procedures and reporting of outcomes for MITTLR. MethodsA systematic literature search to identify primary studies of all designs describing MITTLR was undertaken. How patients were selected for the new technique was examined. The technical Technical outcomes were commonly reported e.g. blood loss (15/16 studies), operative time (15/16) and margin status (11/16). Information on patient reported outcomes and costs were lacking. ConclusionsTechnical details and governance procedures were poorly described. Outcomes focussed on short term details alone. Transparency is needed for reporting the introduction of new surgical techniques to allow their safe dissemination.

Transthoracic transdiaphragmatic approach in laparoscopic liver resection for hepatocellular carcinoma in a patient with severe obesity and history of deceased donor liver transplantation

“…Furthermore, we also measured direct distances from assumed trocar site to the tumor and the responsible Glissonean pedicle to confirm feasibility of every surgical procedure. However, in a recent meta‐analysis by Pathak et al, 8 they reported that minimally invasive transthoracic liver resection is still in a challenging and developing stage. Therefore, further studies are warranted to define the suitable indications and recommendations for TTA in LLRs.…”

Identification of outcomes to inform the development of a core outcome set for surgical innovation: a targeted review of case studies of novel surgical devices

“…Recent systematic reviews have demonstrated that outcome reporting in studies of innovative surgical procedures and devices focuses on short-term, clinical and technical outcomes. 21 22 These outcomes are critical to assess in any early-phase study and are required for US FDA and the UK Medicines and Healthcare products Regulatory Agency approval. 23 24 These types of outcomes are also the recommended focus of early-phase studies (stages 1 and 2) in the IDEAL framework for the introduction and evaluation of new surgical procedures, and devices (IDEAL-D).…”

“…27 Our work has explored the complexities surrounding the introduction of new procedures/devices into routine practice, highlighting shortcomings and inconsistencies in how surgical innovation is evaluated and reported. 21 22 28 This has highlighted the need for consensus on the outcomes that are essential to measure to support the safe and efficient introduction and evaluation of new surgical procedures and devices.…”

“…Recent systematic reviews have demonstrated that outcome reporting in studies of innovative surgical procedures and devices focuses on short-term, clinical and technical outcomes 21 22. These outcomes are critical to assess in any early-phase study and are required for US FDA and the UK Medicines and Healthcare products Regulatory Agency approval 23 24.…”

“…The recent UK Independent Medicines and Medical Devices Safety Review, commissioned after the catastrophic consequences and harms experienced by some patients, highlighted the gaps and inefficiencies in the current regulatory systems 27. Our work has explored the complexities surrounding the introduction of new procedures/devices into routine practice, highlighting shortcomings and inconsistencies in how surgical innovation is evaluated and reported 21 22 28. This has highlighted the need for consensus on the outcomes that are essential to measure to support the safe and efficient introduction and evaluation of new surgical procedures and devices.…”