None listed
Conditions
Brief summary
Abstract Background The systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are features of critical illness that result from a range of aetiologies including trauma, sepsis, haemorrhagic shock and acute pancreatitis. Persistent organ failure is the most common cause of mortality in critical illness. Experimental evidence indicates that gut-lymph draining via the thoracic duct drives SIRS and MODS. Human studies (to confirm the toxicity of thoracic duct lymph in critical illness, analyse its composition and to develop lymph targeted treatments) have been hampered by the inability to easily and reliably access thoracic duct lymph. Aim The aims of this study are i) to optimise the technique of thoracic duct lymphangiography ii) to develop and evaluate a safe, percutaneous, peripheral and transvenous technique of thoracic duct cannulation iii) to determine the composition of human thoracic duct lymph and matched plasma samples during acute pancreatitis iv) to identify factors responsible for toxicity of human thoracic duct lymph Methods This application contains three projects in patients with acute pancreatitis. The first project (n=6) will confirm the technical feasibility and time required to achieve an optimal thoracic duct lymphangiogram by ultrasound guided contrast injection of an inguinal lymph node. The second project (n=12) will refine and develop the technique of peripheral transvenous cannulation of the thoracic duct (PTCTD). The third project will use the thoracic duct lymph collected from patients during the course of the second project to determine the composition and toxicity of the lymph using established laboratory assay platforms. The composition of matched lymph and plasma will also be compared as part of this study.
Interventions
This is a method development study comprised of two sequential phases. The second phase is dependent on the success of the first.
Phase 1: Inguinal lymphangiogram performed by a consultant interventional radiologist. 6 patients with acute pancreatitis exhibiting a SIRS response will be recruited and consented. Using a sterile technique under local anaesthetic and ultrasound guidance an inguinal lymph node will be injected with 3-6mL of iodized oil. Fluoroscopy will then be used to identify opa
This is a method development study comprised of two sequential phases. The second phase is dependent on the success of the first. Phase 1: Inguinal lymphangiogram performed by a consultant interventional radiologist. 6 patients with acute pancreatitis exhibiting a SIRS response will be recruited and consented. Using a sterile technique under local anaesthetic and ultrasound guidance an inguinal lymph node will be injected with 3-6mL of iodized oil. Fluoroscopy will then be used to identify opacification of the thoracic duct and its junction with the venous system. Optimal timing of this opacification will also be assessed. This is expected to take up to 2.5 hours. The volume of contrast and number of lymph nodes injected may need to be varied to improve the fidelity of this project depending on initial results. Phase 2: Inguinal lymphangiogram, percutaneous thoracic duct cannulation and external drainage of thoracic duct lymph performed by a consultant interventional radiologist. 12 patients with acute pancreatitis exhibiting a SIRS response will be recruited and consented. Patients in this phase will receive all three interventions immediately after each other provided that the proceeding intervention is successful. Intervention 1: An inguinal lymphangiogram (developed in Phase 1) will be used to visualise the thoracic duct. Success of the inguinal lymphangiogram in identifying whether the junction of the thoracic duct with the venous system is suitable for cannulation will be determined by the interventional radiologist performing the procedure. Intervention 2: Under a sterile technique and ultrasound guidance the venous system will be accessed from the left antecubital fossa in a manner similar to a PICC line. Thoracic duct cannulation will be attempted from the subclavian vein using standard interventional radiology techniques, guided by lymphangiography and confirmed by the aspiration of lymph. A Pruitt type balloon catheter (or similar) will be placed to simultaneously occlude the thoracic duct and achieve external lymph drainage. Interventions 1 & 2 are expected to take up to 2.5 hours. Intervention 2 will only occur if intervention 1 is successful. This will be determined by the successful aspiration of lymph from the thoracic duct catheter. The guide wires and catheters used may need to be varied to improve the success of this intervention. Intervention 3: The thoracic duct catheter will be connected to a biliary drainage bag to facilitate external thoracic duct lymph drainage for 7 days while the patient is in hospital. Matched peripheral plasma samples will be taken 12 hourly. The volume of lymph drained will be replaced mL:mL with either Plasmalyte or 4% albumin. SIRS, APACHE II and modified Marshall scores along with daily CRP will be recorded to assess patient response to external lymph drainage. Intervention 3 will only occur if interventions 1 & 2 are successful.. If the thoracic duct catheter stops draining lymph before the end of 7 days regular (12 hourly hep saline (50IU in 3mL) flushes will be trialled to maintain patency.
Sponsors
The University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Project 1: Patients over 40 with acute pancreatitis admitted to Auckland City Hospital. Project 2: Patients over 18 with acute pancreatitis exhibiting a SIRS response within 24 hours of admission to Auckland City Hospital.
Exclusion criteria
*Pregnancy *Concurrent MODS *Requirement for either a central venous catheter or PICC line prior to thoracic duct cannulation *Coagulopathy *Patients actively bleeding *Previous thoracic duct injury, intervention or ligation *Previous left neck dissection *Previous groin dissection *Any skin or subcutaneous infection in the groin or antecubital fossa *Previous deep vein thrombosis or pulmonary embolism *Platelet count greater than 800 *Concurrent malignancy *Previous mastectomy or axillary node dissection to the same side as proposed cannulation
Outcome results
None listed