Assessing Surgical Innovation: ALPPS: An IDEAL Example of Disruptive Innovation

Abstract

Objective: To assess the impact of the IDEAL (innovation, development, exploration, assessment and long-term) paradigm on the development of ALPPS (associating liver partition and portal vein ligation for staged hepatectomy) in comparison to the evaluation of 2 other revolutionary innovations: laparoscopic cholecystectomy (LC) and robotic surgery.

Background: The assessment and development of disruptive procedures often follow a chaotic and unstructured approach. The IDEAL paradigm has offered a sequential 5-stage process to assess controversial surgical strategies like ALPPS, which was introduced in 2012 to expand liver surgery for primarily nonresectable disease.

Results: By October 2024, the international ALPPS registry collected 1349 cases from 146 centers in 46 countries. Early reports unveiled an alarming morbidity and perioperative mortality. Accumulating cases in the registry and a consensus conference enabled to reduce the initial 90-day mortality rates >15% to <5% in high-volume centers. Meta-analyses, long-term follow-up and a RCT were available through the growing data in the registry. In comparison, the development of LC was similarly marked by technical advances and a registry to highlight safety (especially bile duct injuries). A small multicenter RCT (and a larger one later) supported an unstoppable wave of rapid adoption by patients and surgeons. Robotic surgery is currently going through close scrutinization by many stakeholders in view of the massive promotion by the industry, but a compelling registry is still missing.

Conclusions: ALPPS has now reached a high-level of evaluation with clear guidelines for use thanks to international collaborations and the IDEAL paradigm. This may serve as template for future evaluations of surgical innovations.

Keywords: ALPPS: associating liver partition and portal vein ligation for staged hepatectomy; CRLM: colorectal liver metastases; IDEAL: innovation; PVE: portal vein embolization; PVL: portal vein ligation; and long-term; assessment; development; exploration.