INTACT-Lymph_Interventional approach to lymphatic leakage
Organizational Data
- DRKS-ID:
- DRKS00015299
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2018-11-12
- Last update in DRKS:
- 2024-01-02
- Registration type:
- Prospective
Acronym/abbreviation of the study
INTACT-Lymph
URL of the study
No Entry
Brief summary in lay language
Lymphatic leakage is a severe complication of surgical procedures. In the context of our study, we want to observe whether, after a direct nodal puncture, Lipiodol reaches the site of lymph leakage, whether lymph leakage is detectable using lipiodol.
Brief summary in scientific language
Lymphatic leakage (LL) is a serious complication of certain surgical procedures, such as nephrectomy, lymph node resection or esophagectomy. The reason for this is a alteration of lymphatics during the surgical procedure. LL can occur in any part of the lymphatic system and cause complications such as chylothorax, lymphocele and lymphatic ascites. The imaging of the LL is possible using ultrasound- or CT-guided direct puncture of an nearby associated lymph node and administration of Lipiodol. After successfull imaging of LL using fluoroscopy visualisation of lymphatic drainage is possible. In our study, we want to observe whether, following a usually direct nodal puncture, Lipiodol reaches the location of lymphatic leakage, weather the LL itself is detectable. Sensitivity and specificity for the visualization and detection of lymphatic leakage/lymphocele will be evaluated. Further results about embolizing effects of lipiodol may be shown and quantified using the gathered information.
Health condition or problem studied
- ICD10:
- T81.9 - Unspecified complication of procedure
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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, a blood and drainage sample is taken. The therapy is carried out by the physican after patient confirmed informed consent is obtained, image-controlled (sonography or CT) puncture of a suitable lymph node and instillation of Lipiodol is performed. As part of the intervention, after local anesthesia, a very fine needle is inserted percutaneously and a defined volume of a fat-soluble contrast agent is injected, either directly into a lymph node or into a lymphatic vessel. Depending on the localization of the lymphatic leak and the presence of accessible lymph nodes, the puncture takes place in the groin or via a dorsal approach for retroperitoneal targets. If necessary, before and / or after treatment, local control is achieved by further non-invasive imaging, e.g. computed tomography (CT). Immediately after the intervention, as well as 14 and 28 days, as well as 3, 6 and 12 months after the intervention, complaints, general condition and amount of drainage are recorded in the outpatient clinic.
Endpoints
- Primary outcome:
- Lipiodol use during routine lymphatic drainage.
- Secondary outcome:
- 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.
Study Design
- Purpose:
- Diagnostic
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik und Poliklinik für Radiologie München
Recruitment period and number of participants
- Planned study start date:
- 2018-11-28
- Actual study start date:
- 2018-11-28
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- 100
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- Klinikum der Universität München, Campus GroßhadernMarchioninistraße 1581377 MünchenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinikum der Universität München Klinik und Poliklinik für RadiologieDr. Willy FlatzMarchioninistr.81377 MünchenGermany
- Telephone:
- (089) 4400-76647
- Fax:
- (089) 4400-76648
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de
Contact for Public Queries
- Address:
- Klinikum der Universität München Klinik und Poliklinik für RadiologieChristel BesselerMarchioninistr. 1581377 MünchenGermany
- Telephone:
- 089- 4400-76642
- Fax:
- 089- 4400-76648
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de
Principal Investigator
- Address:
- Klinikum der Universität München Klinik und Poliklinik für RadiologieDr. Willy FlatzMarchioninistr.81377 MünchenGermany
- Telephone:
- (089) 4400-76647
- Fax:
- (089) 4400-76648
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinikum der Universität München, Campus GroßhadernMarchioninistraße 1581377 MünchenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Med. Fakultät der LMUPettenkoferstraße 880336 MünchenGermany
- Telephone:
- +49-89-440055191
- Fax:
- +49-89-440055192
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-08-20
- Ethics committee number:
- 18-638
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-10-29
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- LMU-RAD00212 - interne Studiennummer
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry