Study to evaluate the effect of arterial embolization prior to surgery on intraoperative blood loss during resection of hypervascularized soft tissue sarcoma (TEAM HYPER-VASC)

Not Applicable

Recruiting

• Conditions: Connective and soft tissue of lower limb, including hip; Connective and soft tissue of upper limb, including shoulder; C49.2; C49.1

• Registration Number: DRKS00025460
• Lead Sponsor: Klinik für Unfall-, Hand- und Wiederherstellungschirurgie Universitätsklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

histologic diagnosed soft tissue sarcoma of extremity or torso
- hypervascularsation of the sarcoma
- age = 18y
- written consent
- sui juris
- compliance

Exclusion Criteria

- age < 18y
- non compose mentis declared by court or public authorities
- inclusion in another clinical trial
- inoperative local tumor
- contraindication on MRI or MRI-angiography
- coagulation disease that contradicts arterial punction
- severe atheromatosis
- for embolisation improperly vascular morphology
- pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intra-and postoperative blood loss in resection of soft tissue sarcoma

Secondary Outcome Measures

Name	Time	Method
- quantity of intraoperative blood loss (ml)<br>- quantity of postoperative blood loss by drainage 48h postoperative (ml)<br>- amount of intra- and postoperative transfused blood products (ml)<br>- operative duration (min)<br>- R-status<br>- local control<br>- metastasis-free survival 24 month after resection