Clinical trial · Observational
Digital Early Warning System for Acute Lung Injury in Liver Surgery
The Construction of a Digital Intelligence Early Warning System for the Whole Process of Acute Lung Injury in Liver Surgery Based on Cardiopulmonary Interaction Characteristics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to develop an explainable machine learning model that takes into account the characteristics of cardiopulmonary interactions. This model will enable early prediction of acute lung injury (ALI) in patients undergoing major liver surgery. The research will create a digital early-warning system for ALI, thereby supporting clinical diagnosis and treatment decisions. This, in turn, should help reduce the incidence and mortality rates associated with ALI.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lung Injury(ALI) | — | UNRESOLVED | — |
| ARDS, Human | — | UNRESOLVED | — |
| Liver Cancer, Adult | Malignant Liver Neoplasm | CURATED_EXACT | 0.85 |
| Liver Cirrhosis | — | UNRESOLVED | — |
| MASLD | — | UNRESOLVED | — |
| MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis) | — | UNRESOLVED | — |
| NAFLD (Nonalcoholic Fatty Liver Disease) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Multicentre External Validation Cohort
- description
- Consecutive eligible adults who underwent major hepatobiliary or pancreatic surgery or liver transplantation at three independent external centres: Peking University International Hospital (WYA), Southwest Hospital of Army Medical University (WYB), and Huangdao District People's Hospital of Qingdao (WYC). The frozen full perioperative M3 model developed at BTCH was applied using the same predictor definitions, imputation rules, model parameters, and classification threshold, without centre-specific model fitting or recalibration. Centre-specific and pooled validation analyses were performed. This was a retrospective observational cohort; no intervention was assigned and routine clinical care was not altered.
- label
- BTCH Development and Validation Cohort
- description
- Consecutive eligible adults who underwent major hepatobiliary or pancreatic surgery or liver transplantation at Beijing Tsinghua Changgung Hospital (BTCH) between October 16, 2015, and December 24, 2025. The earliest 70% formed the development cohort and the most recent 30% formed the temporal-validation cohort. Model development was confined to the development cohort, and the frozen models were evaluated in the temporal-validation cohort. This was a retrospective observational study; no intervention was assigned and routine clinical care was not altered.
Primary outcomes (1)
- measure
- Occurrence of ALI within 7 Days after Surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Undergoing major liver surgery (including two-segment or more hepatectomy, liver transplantation, etc.) * Voluntary participation with signed informed consent
References
Publications (0)
Data not yet available