INTACT-Lymph_Interventional approach to lymphatic leakage

Not Applicable

• Conditions: T81.9; Unspecified complication of procedure

• Registration Number: DRKS00015299
• Lead Sponsor: Klinikum der Universität München, Campus Großhadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Existence of postoperative clinically relevant LL with indication for intervention
- Therapy resistance to conservative treatment options (parenteral nutrition, percutaneous drainage, middle-chain triglyceride diet)
- present lymph nodes / lymphatic vessels / lymphatic leak
- platelets> 50,000 / mm3 (50 GPt / l)
- PTT-INR / PTT> 1.5 times upper limit (patients taking anticoagulants may be included if no underlying blood clotting abnormality has previously been detected)
- Signed informed consent
- Age> 18 years

Exclusion Criteria

- Severe pulmonary insufficiency
- Heart defect with right-left shunt
- Contraindications to treatment with Lipiodol
- contraindications to lymphography
- platelets <50,000 / mm3 (50 GPt / l)
- PTT-INR / PTT <1.5 times the upper standard value
- abnormality of blood clotting

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ipiodol use during routine lymphatic drainage.

Secondary Outcome Measures

Name	Time	Method
Detection of lymphatic leaks using lipiodol in the context of study-controlled data acquisition. Evidence of leakage during clinical routine follow-up by ultrasound or MRI or if clinically indicated by a CT scan.