Vascular Surgical ProcedureLymphFistula-PNCT07499206
Lymphatic Injury Visualization in Vascular Surgery
A study testing Visualization of lymphatic injury and treatment of injury (in case of detection) in people with Vascular Surgical Procedure and Peripheral Arterial Disease(PAD), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study aims to assess a simple intervention: Visualization of lymphatic injury + treatment (in case of detection). This will generate data on the incidence of intraoperative lymphatic injury and the effect of treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Vascular Surgical Procedure, Peripheral Arterial Disease(PAD), Acute Ischemia
- What is being tested?
- Visualization of lymphatic injury and treatment of injury (in case of detection)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients undergoing vascular surgery procedures in the groin
- signed informed consent for study participation
Who cannot join
- pregnant or lactating women
- prior groin surgery
- infected surgical site in the groin
- necessity for further incisions (e.g. bypass surgery)
- incapability of judgement or consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospital Basel
Basel, 4031
Matteo Giardini, Dr. med., +41 61 265 72 22, matteo.giardini@usb.ch
Edin Mujagic, Prof. Dr. med.
About this study
Official title: Visualization and Treatment of Lymphatic Injury During Vascular Surgery Procedures in the Groin: A Pilot Study
This study aims to assess a simple intervention: Visualization of lymphatic injury + treatment (in case of detection). This will generate data on the incidence of intraoperative lymphatic injury and the effect of treatment. This data will then hopefully enable a multi-center RCT to generate high level evidence on this matter.
Read the detailed description
Gaining arterial access in the groin is a very common surgical procedure for vascular surgeons. To reach the femoral artery, invisible lymphatic vessels are often harmed and in turn lymphatic injuries are created. Due to their transparent color and small size, these injuries remain unseen during surgery and are therefore untreated. These small lymphatic injuries can lead to wound complications including lymphoceles, lymphatic fistulas and surgical site infections (SSI) that are associated with higher morbidity and prolonged hospital stay, even mandating re-interventions in some cases.
The investigators hope to reduce wound complication rates by visualizing and directly treating these lymphatic injuries. To be able to detect the injuries, PatentBlau V (E131) will be applied, a blue dye with Swissmedic approval for visualization of lymphatic vessels. Sex differences will be noted and analyzed, gender as a dimension is not relevant.
- Conditions
- Vascular Surgical Procedure, Peripheral Arterial Disease(PAD), Acute Ischemia, Hemmorhage, Aneurysm, Pseudoaneurysm
- Being tested
- Visualization of lymphatic injury and treatment of injury (in case of detection)
- Medical subject headings
- Peripheral Arterial Disease, Aneurysm, Aneurysm, False
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualization of lymphatic injury and treatment of injury (in case of detection)Procedure or surgery
PatentBlau V application: 2ml will be injected intradermally around the groin wound. After allowing a maximum of 10 minutes for lymphatic uptake of the blue dye, a thorough inspection of the wound will be performed to detect possible lymphatic injuries, which will be visible by the blue color.
Direct treatment (e.g. suture, clipping) of visible lymphatic injuries will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Visualization of lymphatic injury | Experimental | Not described Receives: Procedure: Visualization of lymphatic injury and treatment of injury (in case of detection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint: Number of participants with wound complications including lymphocele, lymphatic fistula, and surgical site infection (SSI)
Wound complications defined as follows:
Lymphocele: localized fluid collection at the site of surgical dissection; Lymphatic fistula: persistent external drainage of clear fluid for the wound > 72h after surgery; Surgical Site Infection (SSI): according to the CDC definitions.
Measured: Up to 30 days postoperatively
Secondary outcomes (4)
Intraoperative incidence of lymphatic injury
Measured: Intraoperatively
Rate of re-interventions, defined as further invasive measure in the respective groin
Measured: Up to 30 days postoperatively
Lenght of hospital stay
Measured: Up to 30 days postoperatively
30-day mortality
Measured: Up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499206
- Sponsor's protocol ID
- GCH-008_LymphFistula-Pilot
- Acronym
- LymphFistula-P
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization and Treatment of Lymphatic Injury During Vascular Surgery Procedures in the Groin: A Pilot Study
- ClinicalTrials.gov ID
- NCT07499206
- Acronym / sponsor ID
- LymphFistula-P / GCH-008_LymphFistula-Pilot
- Conditions
- Vascular Surgical Procedure, Peripheral Arterial Disease(PAD), Acute Ischemia, Hemmorhage, Aneurysm, Pseudoaneurysm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess a simple intervention: Visualization of lymphatic injury + treatment (in case of detection). This will generate data on the incidence of intraoperative lymphatic injury and the effect of treatment. This data will then hopefully enable a multi-center RCT to generate high level evidence on this matter.
Detailed description
Gaining arterial access in the groin is a very common surgical procedure for vascular surgeons. To reach the femoral artery, invisible lymphatic vessels are often harmed and in turn lymphatic injuries are created. Due to their transparent color and small size, these injuries remain unseen during surgery and are therefore untreated. These small lymphatic injuries can lead to wound complications including lymphoceles, lymphatic fistulas and surgical site infections (SSI) that are associated with higher morbidity and prolonged hospital stay, even mandating re-interventions in some cases.
The investigators hope to reduce wound complication rates by visualizing and directly treating these lymphatic injuries. To be able to detect the injuries, PatentBlau V (E131) will be applied, a blue dye with Swissmedic approval for visualization of lymphatic vessels. Sex differences will be noted and analyzed, gender as a dimension is not relevant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visualization of lymphatic injury | Experimental | Procedure: Visualization of lymphatic injury and treatment of injury (in case of detection) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients undergoing vascular surgery procedures in the groin
- signed informed consent for study participation
Key exclusion criteria (5 listed)
- pregnant or lactating women
- prior groin surgery
- infected surgical site in the groin
- necessity for further incisions (e.g. bypass surgery)
- incapability of judgement or consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visualization of lymphatic injury and treatment of injury (in case of detection)PatentBlau V application: 2ml will be injected intradermally around the groin wound. After allowing a maximum of 10 minutes for lymphatic uptake of the blue dye, a thorough inspection of the wound will be performed to detect possible lymphatic injuries, which will be visible by the blue color. Direct treatment (e.g. suture, clipping) of visible lymphatic injuries will be performed. | Procedure or surgery | Visualization of lymphatic injury |
Primary outcome
Composite endpoint: Number of participants with wound complications including lymphocele, lymphatic fistula, and surgical site infection (SSI)
Time frame: Up to 30 days postoperatively
Wound complications defined as follows: Lymphocele: localized fluid collection at the site of surgical dissection; Lymphatic fistula: persistent external drainage of clear fluid for the wound > 72h after surgery; Surgical Site Infection (SSI): according to the CDC definitions.
4 secondary outcomes
Intraoperative incidence of lymphatic injury
Time frame: Intraoperatively
Rate of re-interventions, defined as further invasive measure in the respective groin
Time frame: Up to 30 days postoperatively
Lenght of hospital stay
Time frame: Up to 30 days postoperatively
30-day mortality
Time frame: Up to 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visualization of lymphatic injury and treatment of injury (in case of detection) in people with Vascular Surgical Procedure and Peripheral Arterial Disease(PAD), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Giardini, Dr. med. (+41 61 265 72 22, matteo.giardini@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint: Number of participants with wound complications including lymphocele, lymphatic fistula, and surgical site infection (SSI) (time frame: Up to 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.