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INTACT-Lymph_Interventional approach to lymphatic leakage

INTACT-Lymph_Interventional approach to lymphatic leakage - INTACT-Lymph

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015299
Enrollment
100
Registered
2018-11-12
Start date
2018-11-28
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

T81.9

Interventions

Group 1: As part of routine intervention, the patient is hospitalized. The inclusion criteria for the planned recruitment are evaluated by present CT or MRI imaging. Immediately prior to treatment,

Sponsors

Klinikum der Universität München, Campus Großhadern
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Lipiodol use during routine lymphatic drainage.

Secondary

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactChristel Besseler

Klinikum der Universität München Klinik und Poliklinik für Radiologie

christel.besseler@med.uni-muenchen.de089- 4400-76642

Outcome results

None listed

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