Digital Early Warning System for Acute Lung Injury in Liver Surgery

NCT07070362 | Recruiting

• 4 other identifiers: BRWEP2024W03224011325254-0-01（BA）KY2026022LL-KY-2026008
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 4

Brief Summary

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

Acute Lung Injury(ALI); Liver Cirrhosis; ARDS, Human; MASLD; NAFLD (Nonalcoholic Fatty Liver Disease); Liver Cancer, Adult; MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)

Keywords

Digital Intelligence; Acute Lung Injury; PPCs; Liver Surgery; Cardiopulmonary Interaction;

Outcome Measures

Primary Outcomes (1)

• Occurrence of ALI within 7 Days after Surgery

  Berlin Definition: 1. Onset: Acute exacerbation of known injury or new/worsening respiratory symptoms within 1 week. 2. Chest Imaging (X-ray or CT): Bilateral pulmonary shadows not fully explained by exudation, atelectasis, or nodules. 3. Pulmonary Edema Etiology: Respiratory failure not fully attributed to heart failure or fluid overload; if no related risk factors, objective tests (e.g., Doppler echocardiography) are needed to exclude hydrostatic pulmonary edema. 4. Oxygenation Levels: Mild - With CPAP/PEEP \>5 cmH2O, 200 mmHg \< PaO2/FiO2 \< 300 mmHg; Moderate - With CPAP/PEEP \>5 cmH2O, 100 mmHg \< PaO2/FiO2 \< 200 mmHg; Severe - With CPAP/PEEP \>5 cmH2O, PaO2/FiO2 \< 100 mmHg.

  Perioperative period (Perioperative): Refers to the entire process from the determination of surgical treatment to postoperative rehabilitation (e.g., from 1 day before surgery to 7 days after surgery).

Study Arms (2)

Multicentre External Validation Cohort

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.

BTCH Development and Validation Cohort

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.

Interventions

None-placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patient refusal * Presence of comorbidities affecting outcome assessment * Incomplete outcome records * Postoperative follow-up failure * Participation in other studies that may interfere with outcome assessment

You may qualify if:

• Age ≥ 18 years
• Undergoing major liver surgery (including two-segment or more hepatectomy, liver transplantation, etc.)
• Voluntary participation with signed informed consent

Sponsors & Collaborators

• Peking University International Hospital: collaborator
• Huangdao District People's Hospital of Qingdao: collaborator
• The First Affiliated Hospital of Army Medical University (Southwest Hospital): collaborator
• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (4)

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University

Beijing, Beijing Municipality, 102218, China

RECRUITING

Peking University International Hospital

Beijing, China

RECRUITING

Southwest Hospital, The First Affiliated Hospital of Army Medical University

Chongqing, China

RECRUITING

Huangdao District People's Hospital of Qingdao

Qingdao, China

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury; Liver Cirrhosis; Respiratory Distress Syndrome; Non-alcoholic Fatty Liver Disease; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Fatty Liver; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Central Study Contacts

Gao Zhifeng, MD

CONTACT

+8615801249466; btchgzf@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 17, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)