Robotic Recipient Liver Transplantation
Background and Rationale
Robotic recipient liver transplantation is expanding, yet outcomes are reported from single centers and selected cohorts. A prospective, international registry is needed to establish real-world safety, effectiveness, and learning curves, and to standardize reporting across programs. This mirrors the successful approach used in disease-specific transplant registries, which demonstrated the value of prospective, multicenter data to measure morbidity, mortality, and modifiable predictors of outcome.
Objectives
Primary objective
- Describe 90-day morbidity and mortality after robotic recipient liver transplantation, including total robotic, planned hybrid, and unplanned conversions.
Secondary objectives
- Quantify short-term and 12-month outcomes (complications, rescue, graft/recipient survival).
- Identify modifiable predictors of outcomes (patient, graft, technique, program factors).
- Characterize adoption/learning curves and technology use (platforms, adjuncts, imaging).
- Enable benchmarking and quality improvement through standardized metrics and shared analyses.
Study Design
International, multi-center, observational registry. No randomization or mandated interventions. Centers submit consecutive eligible cases (retrospective and prospective) using a standardized electronic case report form (eCRF). The study is non-interventional and focuses on data safety and confidentiality.
Center Eligibility and Team
Center Eligibility
- Any transplant center performing robotic recipient transplantation may participate. No minimum case volume.
- Each center names a Local PI, up to two additional collaborators, and one independent local auditor (non-surgeon) responsible for protocol adherence and data verification.
Case Eligibility
Inclusion
- Adult or pediatric robotic recipient liver transplants: total robotic, planned hybrid, or conversions to open.
- Graft source: living-donor or deceased-donor, whole or split grafts.
- Consecutive case capture per center.
Exclusion
- Domino graft recipients (for consistency with prior registry frameworks).
- Prospective & Retrospective capture:
- Prospective: cases performed after a center’s activation date, entered at/near time of care.
- Retrospective (startup allowance): historical robotic recipient LT cases performed before activation, entered from existing records.
Data Collection and Variables
Electronic Case Report Form (eCRF) captures
- Center and program: platform, team structure, experience, adoption stage.
- Recipient baseline: demographics, disease category, MELD at listing, portal hypertension/PVT, comorbidities, prior surgery.
- Donor/Graft: DBD/DCD, whole/split, preservation/perfusion method, key anatomic considerations.
- Operation details: approach (total robotic/hybrid/converted), port map/docking, extraction incision, anastomotic counts/technique, adjuncts (ICG, cholangiography), inflow modulation, flowmetry, times (explant/implant phases, ischemia, anhepatic), transfusion.
- Short-term outcomes (index admission): ICU/ventilation, ERAS elements, complications (Clavien-Dindo), EAD/PNF/SFSS elements, readmissions, mortality.
- 12-month outcomes: graft and patient survival, major complications, (oncology where applicable).
The eCRF uses field definitions, min/max ranges, and mandatory fields to reduce entry errors and standardize data.
Outcomes and Analytic Plan
- Primary endpoint: 90-day morbidity and mortality (recipient).
- Key secondaries: in-hospital outcomes, 12-month graft/recipient survival, complication/rescue rates, learning-curve metrics.
Analyses include descriptive statistics and multivariable modeling to identify independent predictors, periodic reports will be issued once sufficient valid cases accrue and then at regular intervals.
Monitoring and Data Quality
- Local auditors verify adherence and data completeness.
- Central monitoring of exports occurs periodically, sites may undergo remote or on-site peer monitoring.
Data Protection and Confidentiality
- Fully anonymized patient-level data, no surgeon- or center-identifying reporting in public outputs.
- Secure, role-based access, encrypted transmission, GDPR/HIPAA-aligned handling.
Data Custodianship and Access
- IRTregistry.org acts as data custodian on behalf of all contributors.
- Each contributor may access their own submissions, study-level data sharing and analysis proposals are reviewed by registry leadership for methodological quality and validity.
Ethics
The registry is observational and does not alter clinical management. Many jurisdictions treat such anonymized quality registries as audit/quality-improvement. Nevertheless, each Local PI is responsible for obtaining any required approvals per local regulations. Template documentation (e.g., DSA/DTA) is available to support sites.
Governance and Publication Policy
- Governance: Chief Investigators with Scientific/Data/Management committees oversee scientific priorities, data integrity, methods, and operations.
- Publication model:
- Registry-wide reports: group authorship (“IRTregistry.org Collaborative”).
- Member-led analyses: named writing group plus “IRTregistry.org Collaborative,” following ICMJE criteria.
- Authorship eligibility requires verified data contribution and audit compliance.
Risks and Benefits
- Risks: No direct patient risk, primary focus is data safety and confidentiality.
- Benefits: Benchmarking, shared learning, evidence generation, and accelerated best-practice adoption.
Platform and Operations
- Secure web platform with authenticated accounts, standardized CRFs, and controlled exports, periodic updates and backups, cross-browser/device support.
Participation and Onboarding
- Register online at IRTregistry.org.
- Interested centers contact office@IRTregistry.org for onboarding, auditor designation, and activation. Consecutive case submission is required once active.