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Development of a composite endpoint for randomized controlled trials in liver surgery
M A J van den Broek1, R M van Dam, G J P van Breukelen
1Department of Surgery, Maastricht University Medical Centre, Maastricht University, Maastricht, The Netherlands.
The British Journal of Surgery
|May 11, 2011
Summary
Researchers developed a liver surgery-specific composite endpoint (CEP) to improve randomized controlled trials (RCTs). This novel CEP, comprising key complications, increases event rates, making future surgical trials more feasible and comparable.
Area of Science:
- Hepatobiliary Surgery
- Clinical Trial Design
- Surgical Outcomes Research
Background:
- Randomized controlled trials (RCTs) in liver surgery face challenges due to low incidence of single-component endpoints, necessitating large sample sizes.
- A liver surgery-specific composite endpoint (CEP) offers a potential solution to enhance trial feasibility.
- This study aimed to develop and validate a well-defined CEP for liver surgery.
Purpose of the Study:
- To establish a liver surgery-specific composite endpoint (CEP).
- To define the components of the CEP based on expert consensus and literature review.
- To assess the event rate and impact of the CEP on sample size requirements for RCTs.
Main Methods:
- A systematic literature search and consensus among 28 international hepatopancreatobiliary (HPB) surgeons were employed to select CEP components.
- Two prospective cohorts of liver surgery patients from high-volume HPB centers were analyzed.
- The event rate and effect of the CEP on RCT sample size were evaluated.
Main Results:
- The liver surgery-specific CEP includes ascites, postresectional liver failure, bile leakage, intra-abdominal hemorrhage, intra-abdominal abscess, and operative mortality (Clavien-Dindo grade ≥3) within 90 days.
- The CEP incidence was 19.2% in one cohort and 10.7% in the other.
- Implementing the CEP approximately halved the theoretical sample size for adequately powered RCTs.
Conclusions:
- The proposed liver surgery-specific CEP comprises ascites, postresectional liver failure, bile leakage, intra-abdominal hemorrhage, intra-abdominal abscess, and operative mortality.
- This CEP demonstrates a significantly higher event rate compared to individual components.
- Adoption of this CEP is expected to enhance the feasibility and comparability of liver surgery RCTs.
