- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07297615
3D Liver Volumetry
Accuracy of Individualized 3D Reconstruction in Predicting Liver Resection Volume: A Prospective Study
The study aims to improve preoperative evaluation of liver resection volume in patients undergoing major hepatectomies. Accurate prediction of the planned resection and the future liver remnant (FLR) is critical to minimize the risk of postoperative liver failure, which is associated with increased morbidity and mortality. Conventional imaging-based volumetry may have limited accuracy. This study investigates the use of individualized 3D liver models combined to enhance visualization and volumetric analysis of liver anatomy and resection boundaries.
Patients are recruited in the liver outpatient clinic and, upon consent, preoperative 3D models are created using Medics 3D. During surgery, the planned resection is guided by the individualized 3D models. Postoperatively, the resected specimen undergoes CT-based volumetry to compare the predicted resection volume from the 3D model with the actual volume. Routine postoperative follow-up is conducted. The study aims to optimize surgical planning, enhance the accuracy of future liver remnant prediction.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Graz, Austria
- Medical University of Graz - Department of Surgery, Division of General, Visceral and Transplantationsurgery
-
Contact:
- Mohamed El-Mahrouk, MD
- Phone Number: +43 316 385 81191
- Email: mohamed.el-mahrouk@medunigraz.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients (≥18 years) undergoing open or minimally invasive major liver resection at the Clinical Division of General, Visceral and Transplant Surgery who provide written informed consent prior to participation will be included.
Exclusion Criteria:
- Patients unable to provide informed consent will be excluded.
- Minor resections.
- Contraindications to MRI.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Volumetry through 3D reconstruction
Preoperative liver volumetry using individualized 3D reconstructions to guide major hepatectomy, optimize resection planning, and improve prediction of the future liver remnant.
|
Preoperatively, every patient in this study will undergo an individualized 3D reconstruction of their liver to perform accurate volumetry.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessment of the preoperative volumetry of the liver portion planned for resection using a 3D model and comparison with the postoperative resection specimen volume.
Time Frame: Approximately 2-3 weeks are required between preoperative volumetry and postoperative volumetry comparison.
|
Approximately 2-3 weeks are required between preoperative volumetry and postoperative volumetry comparison.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1465/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Cancer
-
Slawa CwajnaNova Scotia Health AuthorityWithdrawnPrimary Liver Cancer | Metastatic Liver CancerCanada
-
Duke UniversityCompletedPrimary Liver Cancer | Metastatic Liver Cancer From Any Cancer SiteUnited States
-
Célia TurcoCompletedPrimary Liver Cancer | Liver Metastases | Secondary Liver CancerFrance
-
University of CincinnatiActive, not recruitingLiver Metastases | Advanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Recurrent Adult Primary Liver CancerUnited States
-
Lisa H. Butterfield, Ph.D.National Cancer Institute (NCI)TerminatedHepatocellular Carcinoma | Liver Cancer | Cancer of Liver | Hepatoma | Hepatocellular Cancer | Hepatic Cancer | Liver Cell Carcinoma | Cancer, Hepatocellular | Liver Cancer, Adult | Liver Cell Carcinoma, Adult | Cancer of the Liver | Neoplasms, Liver | Hepatic Neoplasms | Neoplasms, HepaticUnited States
-
Radboud University Medical CenterTerumo Medical CorporationCompletedPrimary Liver Cancer | Liver Cancer | Liver Metastasis Colon CancerNetherlands
-
Shanghai Huihe Medical Technology Co., LtdEnrolling by invitation
-
Burzynski Research InstituteTerminatedPrimary Liver CancerUnited States
-
Tianjin Medical University Cancer Institute and...RecruitingPrimary Liver CancerChina
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Recruiting
Clinical Trials on 3d reconstruction
-
Ruijin HospitalGuangdong Provincial People's Hospital; Union hospital of Fujian Medical UniversityCompleted
-
University Hospital, Basel, SwitzerlandActive, not recruitingTotal Knee Arthroplasty (TKA)Switzerland
-
Guangdong Provincial People's HospitalActive, not recruiting
-
Yonsei UniversityCompletedGastric CancerKorea, Republic of
-
Mayo ClinicCompletedRegenerative Medicine | Nasal Surgical ProceduresUnited States
-
University of PecsCompleted
-
Fundació d'investigació Sanitària de les Illes...Asociacion Española de ColoproctologiaNot yet recruitingColon Neoplasms | Locally Advanced Colon Cancer | 3D Reconstruction
-
Imperial College LondonRecruitingObesity | Bariatric Surgery Candidate | Body Image DisorderUnited Kingdom
-
Ospedale Centrale BolzanoChinese University of Hong Kong; Wolfson Medical Center; Harvard University; University... and other collaboratorsNot yet recruitingLung Cancer | Lung; Node