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Microwave Ablation for Organ Preservation in Traumatic Splenic Rupture: A Multicenter Randomized Controlled Trial (MAST Trial)

Clinical study of microwave ablation in spleen-preserving surgery for traumatic splenic rupture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108233
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic splenic rupture

Interventions

Microwave ablation (MWA) group:Microwave Ablation for Spleen Preservation
Autologous transplantation (AST) group:Splenectomy with autologous spleen transplantation
Splenectomy Group:Splenectomy

Sponsors

Suining Hospital of Traditional Chinese Medicine Affiliated with North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Definitive Diagnosis: Traumatic splenic rupture was confirmed in all cases using abdominal CT scan, with additional assessment by eFAST ultrasound when indicated. Diagnostic peritoneal aspiration was performed in cases where imaging findings required further clarification. 2. Surgical Indications: Enrollment required fulfillment of >=2 criteria: (1) AAST grade III-IV parenchymal injury; (2) persistent hemodynamic instability (systolic blood pressure 20 minutes or vasopressor requirement); (3) radiographic evidence of >=600 mL intraperitoneal hemorrhage; (4) failure of nonoperative management. 3. Operational Feasibility: Anatomic eligibility demanded either: (1) sufficient residual parenchyma for MWA (>=30% viable tissue post-ablation) (2) adequate quality splenic tissue for AST (>=10 transplantable fragments). 4. Ethical Compliance: Formal inclusion mandated documented written informed consent from patients or legal guardians, coupled with complete 90-day postoperative follow-up data.

Exclusion criteria

Exclusion criteria: 1. Anatomical & Pathological Exclusions: (1) preoperative identification of functional accessory spleens, (2) preexisting conditions mandating splenectomy, including hematologic disorders and primary/metastatic splenic malignancies. 2. Clinical Contraindications: (1) concurrent hollow viscus perforation; (2) active intra-abdominal infection; (3) life-threatening polytrauma requiring emergent intervention for associated injuries. 3. Protocol Deviations: Patients exceeding damage control parameters (>1000 mL blood loss during procedure or >4 hours operative time) were excluded. 4. Follow-up Compliance: Exclusion applied to patients with either incomplete perioperative records or inadequate 60-day postoperative follow-up documentation.

Design outcomes

Primary

MeasureTime frame
Intraoperative Metrics: Skin-to-skin time (minutes), estimated blood loss (mL, suction+gauze weight);Technical Success;60-day postoperative complications;

Secondary

MeasureTime frame
Splenic function;Structural Preservation;Clinical Outcomes;Recovery Quality;

Countries

China

Contacts

Public ContactJian Du

Suining Hospital of Traditional Chinese Medicine Affiliated with North Sichuan Medical College

doctorsongyun@sina.com+86 186 8252 8003

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026