Transcript Informed Consent

Informed Consent
Improving Resident Efficiency and
Competency
Informed Consent Basics
• At the root of any informed consent is understanding of the
procedure, its intended benefit, complications and their likelihood,
and alternatives to the procedure
• The Handbook of Interventional Radiologic Procedures (Lippencott
Williams & Wilkins) provides adequate explanation of any
procedure you will be consenting for.
• The following slides are aimed at preparing you for everything else
Why is this important?
2003 study in Europe was the only study to examine patient and physician
opinions on informed consent as of a Pubmed search of 11/2013
786 interventional radiologists (attending level) polled
-Respondents were asked whether they felt patients received adequate
explanation regarding indications for intervention, the procedure, alternative
treatment options, and complications. (Junior medical staff obtained consent
in 58% of cases)
-Only 69% of respondents were satisfied with their level of explanation
regarding indications for treatment
-Only 79% felt that they adequately explained the procedure.
-No formal studies on IR related informed consent are available in the
United States literature.
-No studies have been published that documented junior medical staffs
comfort level of the procedure and consent for the procedure
The Dichotomy
How we see it
How the patient sees it
Components of Informed Consent
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Disclosure
– Informer must supply the subject
with enough information to make
an autonomous decision
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Capacity
– Patient must both understand the
information provided and form a
reasonable judgment based on
the potential consequences of
his/her decision.
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Voluntariness
– Patient has a right to freely
exercise his/her decision making
without being subjected to
external pressure such as
coercion, manipulation, or undue
influence
Informed Consent
6 Components of a true informed consent:
1. The purpose and nature of the
procedure or treatment.
2. The method by which the procedure or
treatment will be performed.
3. The risks, complications, and expected
benefits or effects of such procedure
or treatment.
4. The risk of not accepting the procedure
or treatment.
5. Any reasonable alternatives to the
procedure or
treatment and their most likely risks and
benefits.
6. The right to refuse the procedure or
treatment.
In Case of Emergency…
Here are the rules:
1. When any delay in treatment would jeopardize the health of a patient, and the patient is unable to
give informed consent, the physician can imply consent.
2. If the patient is unable to consent and has a legally authorized representative who is available to
consent, the treating physician must obtain the informed consent of the representative.
3. When informed consent cannot be obtained from the patient or from his or her legally authorized
representative, the physician treating the patient should determine the immediacy of the need for
treatment.
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a. A physician may provide any treatment or perform any procedure immediately required to prevent serious
disability or death or to alleviate great pain and suffering.
b.During the course of an operation or a procedure, a physician may perform any procedure that becomes
necessary because of a condition discovered or arising during the operation or the procedure that presents
an immediate threat to the life or the health of the patient.
4. Even if emergent, if patient is competent, they can deny a life saving procedure.
“Pain, Bleeding, Infection…”
 Procedures vary greatly in complexity and associated complications.
 Complications are unique to each procedure.
 This is what we do, just to name a few :
Angioplasty and Vascular Stenting
Aortic stent graft placement
Biliary Interventions
Catheter Angiography
Catheter Embolization
Catheter-directed Thrombolysis
Chemoembolization
Chest tube placement
Chest port placement
Dialysis access
Dialysis and Fistula/Graft Declotting and
Interventions
Inferior Vena Cava Filter Placement and
Removal
Needle Biopsy under CT and Ultrasound
guidance Renal Angiogram
Tunneled Central Venous Catheter
Transjugular Intraheptic Portosystemic
Shunt Procedure
Transjugular Liver Biopsy
Needle Biopsy of the Thyroid
Paracentesis and Thoracentesis
Percutaneous Abscess Drainage
Percutaneous Gastrostomy
Radiofrequency Ablation of Tumors
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Uterine Fibroid Embolization
Varicocele Embolization
Vascular Access Procedures
Vertebroplasty & Kyphoplasty
Vascular Malformation Sclerotherapy
Carotid Angiogram
Chest Port
Inferior Vena Cava Filter
Liver Transarterial Chemoembolization
Percutaneous Abdominal or Pelvic Drain
Percutaneous Dialysis Fistula Graft
Radiofrequency Ablation
Uterine Fibroid Embolization
Vertebroplasty and Kyphoplasty
Yttrium-90 Radiotherapy
Central Venous Access
Indications for Placement
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Monitoring of the central venous pressure (CVP) in acutely ill patients to quantify
fluid balance
Long-term Intravenous antibiotics
Long-term Parenteral nutrition especially in chronically ill patients
Long-term pain medications
Chemotherapy
Drugs that are prone to cause phlebitis in peripheral veins
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KCl; Vasopressors; Amiodarone
Plasmapheresis
Peripheral blood stem cell collections (Trifusion)
Dialysis (Hickman)
Frequent blood draws
Frequent or persistent requirement for intravenous access
Need for intravenous therapy when peripheral venous access is impossible (rare)
Central Lines: Potential
Complications (Jugular access)
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Pneumothorax – range from 0.1-1% (more in SCV placement)
Delayed PTX – 0.5% of all pneumothoraces (>6h after placement)
Malposition – usually not an issue with image guided placements
Cardiac arrythmia – up to 25% - Usually resolves with withdrawl of wire but can
cause malignant arrythmia.
Guidewire loss
Catheter related thrombosis
Air embolism
Venous Perforation
Inability to place catheter
Others include Chylothorax (LIJV), lympohocutaneous fistula,
Vascular injury (Carotid puncture) – 1-6%. Use of ultrasound aids inadvertent arterial
puncture.
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Up to 40% of Carotid punctures are associated with hematoma formation. Other
complications include stroke, AVF, psuedoaneurysm formation
Death
Postrprocedure : thrombosis, venous stenosis, infection, catheter fracture, air embolism on
extraction
Complications by Site
Central Lines – Complication
factors
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Inexperience, variably defined but with a consistent relationship
between less experience and the rate of complications.
Number of needle passes, with the incidence of complications rising
with two venopunctures
Body mass index, previous catheterizations, and severe
dehydration or hypovolemia are factors that increase risk.
Coagulopathies do not appear to increase the risk of percutaneous
insertion, if appropriate measures are taken to attempt correction of
coagulopathy.
Large catheter size
Unsuccessful insertion attempts is the strongest predictor of
complication.
Overall, 5-19% reported incidence of complications in ICU
patients – much less in IR.
Paracentesis
Indications
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Diagnostic
– New onset ascites
– Suspected spontaneous or secondary SBP Including :
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Fever
Leukocytosis
Vomiting
Abdominal tenderness
Paralytic ileus
New hospitalization or ER visit
Hepatic Encephalopathy
Renal Failure (new onset)
Worsening liver function
Therapeutic
– Respiratory compromise
– Abdominal pain or pressure
Paracentesis Complications
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Post paracentesis hypotension (73% if 5-8L)
Bacterial peritonitis (<1%)
Hemoperitoneum (<1%)
Abdominal wall hematoma (<1%)
Site infection
Ascitic leakage
Hyponatremia
Death
Paracentesis in thrombcytopenia
• JVIR article Apr 2013
– 304 Paras completed by Attendings and juniors
– Platelets <50k (mean 38k): INR avg 1.6
– <1% major bleeding complication (Req Transfusion)
**Bleeding complication risk is extremely low, unless
organ or arterial injury occurs. **
 NEJM does not recommend platelet or FFP
transfusion preprocedure.
Hepatology: Albumin reduced post paracentesis circulatory dysfunction (PCD)
events by 66% in patients with 5-8L removed. Above graph shows it superior to
various other alternative treatments
•Albumin reduced hyponatremia events by 42% when compared with no treatment
•Reduced Death rates by 36%
Thoracentesis
Indications
Diagnostic:
– All new effusions
Therapeutic:
– Respiratory distress
Contraindications
• Chest wall cellulitis
• Severe Coagulopathy
• Severe lung disease (Pneumothorax risk)
• Mechanical Ventilation (Decreased resealing)
Thoracentesis Complications
Major Complications:
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Pneumothorax (3-30%)
Hemopneumothorax
Hemorrhage (0.2%)
Hypotension (vasovagal response) (0.6%)
Reexpansion pulmonary edema ().5% when >1L removed
Death
Minor Complications:
- Dry tap (no fluid return)
- Subcutaneous hematoma or seroma (0.2%)
- Anxiety
- Pain
- Shortness of breath (1%)
- Cough (0.8%)
IVC Filter Placement
Decision tree – Assesment of Filter placement, choice
of filter, method of placement
Indications and ACR guidelines –
Filter placement
Inferior vena cava filter placement is most commonly indicated for deep venous
thrombosis (DVT) or pulmonary embolism when anticoagulation therapy is
contraindicated. Other indications detailed in chart on prior slide
-Per the ACR Appropriate Criteria guidelines, free floating ileofemoral DVT is the
only “usually appropriate” indication besides contraindication to anticoagulation
and documented PE.
- Almost all other indications are considered “may be appropriate” per ACR.
IVC Filter Placement Complications
• Venous Access site (<1%) –
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Bleeding
Hematoma
Infection
AVF
Thrombosis
• PE despite filter placement –
– 5.6% lifetime risk; Fatal in 3.7%
• IVC thrombosis – 2.7%
– incidence varies by filter, but this can cause critical phlegmasia and
preclude removal.
Filters decrease the risk of PE, but increase the risk of DVT. De
novo DVT rates approach 14% after filter placement.
Filter Malposition
• Highly variable
– Due to operator experience
– Minor malposition
• crossed filter legs or filter tilt (which decreases the efficacy of
the filter)
– Major malposition :
• Malposition in the IVC (suprarenal)
• Deployment into a nonintended vein (dilated lumbar)
• Filter migration.
– This can happen in the acute phase of deployment or can
happen as the result of delayed migration.
– Patients must be aware, that despite rare, this can require
major surgical intervention to fix.
Retrieval complications
• Not all filters can be retrieved safely/successfully
• IVC perforation by filter legs is common,
– Incidence ranging from 40-95%.
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Aortic, ureteral, lumbar arterial, frank IVC rupture, duodenal perforation can
occur as a result of perforation . Frank IVC tear on retrieval can occur if the
legs transgress the IVC
• Fractured struts are common, fractured baskets are uncommon
(fortunately). Fractures struts are rarely of clinical significance, and
can be left in place in the absence of problems.
• Device infection is luckily an extremely rare complication.
– In select case reports, cultures from the device itself have turned up
negative. Tissue or clot debris in the filter have been the culprits in
select cases.
• Death
Surgical excision of a right atrial
filter
Postprocedure management
Always schedule patient for retrieval
IVC filter removal under anticoagulation is
appropriate
If you fail, Try Harder.
Transjugular Liver Biopsy
Indications
Patients with diffuse liver disease requiring biopsy
with 1 or more of the following conditions:
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Deranged coagulation
Massive ascites
Liver abnormalities such as peliosis hepatitis
In combination with transjugular intrahepatic
portosystemic shunt (TIPS) or venography
Any other contraindication for percutaneous biopsy
Failed percutaneous biopsy
Morbid obesity
Soft indication for pressure measurement to
determine functional portal hypertension
Complications
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The complications are access site - related and cardiac or hepatic
complications.
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Liver capsule puncture
Liver hematoma
Hematobilia
Cardiac arrythmia
Portal vein – Arterial/Bilious fistula
Psuedoaneurysm
Renal failure/Contrast reaction
All vascular access complications.
Death
The reported total complication rate is 7.1%. ( 1.3-20.2% depending on the
source)
Mortality rates of 0.09% (adults) and 0.1% (children) have also been
reported.
Mortality is due to hemorrhage from the liver or ventricular arrhythmia. Other
complications included neck pain, hematoma in the neck, carotid artery
puncture, pneumothorax
Common Patient Questions
How common are nondiagnostic biopsies?
• Fragmentation rates vary between 10-24%
• Diagnostic sample rates vary between 2-10%
How long will the procedure take?
• Average fluoroscopy time : 4 min
• The mean duration of the procedure is 40 min
• Radiation dose ranges from 0.5 - 1 mSv.
How often is conversion to percutaneous biopsy required?
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A technical success rate of 96.8% has been reported in a recent metaanalysis that included more than 7500 cases. (3.2% conversion rate)
Inability to catheterize the RHV was the most common reason (43.3%) for
failure.
Percutaneous Gastrostomy
Willis Oglesby (WOG) tube
Indications
• Dysphagia due to neurological
disorder
• Head and neck malignancies
requiring surgical therapy or
radiation that may inhibit
access to nutrition
• Chronic disease states where
the patient cannot fill caloric
requirements by oral intake
alone
• Intestinal disorders requiring
special formula for feeding
• Palliative for gastric outlet
obstruction or small bowel
tumor
Why we do it, not GI
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Percutaneous radiological gastrostomy (PRG) has a success rate
comparable to that of the Surgical/endoscopic method, with lower morbidity
and mortality rates.
– PRG has a success rate at 99.2%, PEG (95.7%), Surgical (100%)
– Total and major complication rates Surgery (29% and 19.9%, respectively); PEG
(15.4% and 9.4%); and PRG (13.3% and 5.9%)
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May be performed in patients for whom the endoscopic method would be
difficult or dangerous, such as those with head and neck malignancies (can
avoid potential complications with endo as well as the low associated tumor
seeding rate)
We’re not always perfect …
Contraindications
Absolute
• Uncorrected coagulopathy remains an absolute contraindication due to the possibility
of uncontrollable internal hemorrhage.
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Preprocedure screening should be performed, and coagulopathy corrected
Suggested acceptable parameters include an International Normalized Ratio (INR) of 1.3 or
less and a platelet count of at least 80 × 109/L.
If possible, this procedure should also be avoided in patients with portal hypertension and
varices due to the potential for massive hemorrhage.
Relative
• Many patients requiring gastrostomy placement are immunosuppressed, either due to
their underlying illness or to the use of medications such as steroids.
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Immunosuppression is associated with higher rates of pericatheter leakage,and this should
be considered in preprocedure assesment/consent.
Interposition of either colon or liver between the stomach and anterior abdominal wall
Previous major gastric surgery
Ascites (if controllable through drainage or diuretics PRG can be considered.)
To pexy or not to pexy…
Support:
- Reduces the risk of initial peritoneal
catheterization
- Pericatheter gastric leakage
- Later intraperitoneal tube migration
Also:
- Replacement of dislodged tubes is easier,
leading to lower rates of repeat gastrostomy
(formation of adhesions maintains alignment
and allows the mucocutaneous tract to mature
earlier)
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Animal studies have shown that when
gastropexy is used, adhesion between the
stomach and abdominal wall occurs as early as
24 hours after the procedure.
(It may also make the primary placement of
larger tubes, which are believed to have lower
occlusion rates, easier, and by acting as a
tamponade, may decrease the risk of early
gastric hemorrhage)
Against:
- Thorton et al (2002) showed
no difference in mortality,
(N=48)
- Incidence of discomfort or
erosion of T-Tacs has been
reported, and discomfort can
approach 20%.
- Additional gastric punctures
may be associated with a
higher risk of hemorrhage.
-Potential for T-fasteners to
cause skin ischemia and
pressure necrosis
-Gastropexy adds complexity
and time, and as a result,
cost, to the procedure.
Complications
Major complications:
– Peritonitis
– Septicemia
– Significant stomal infection
– Aspiration
– Hemorrhage
– Gastrointestinal perforation
– Dislodgment of tube requiring repeat
procedure or surgery
Minor complications:
-low-grade pericatheter leakage
- superficial stomal infection
- tube dislodgment not requiring repeat
procedure
- tube occlusion
- tube or balloon rupture
Common Gastrostomy Tube Management
Questions: A reference
How do I clean the tube site?
- Soap and water are recommended. Avoid hydrogen peroxide or alcohol as they
may irritate the skin or inhibit healing.
-Antibiotic creams are generally not recommended as they increase skin maceration
I’m getting nauseated with feeds, what do I do?
- Gently pull back on the tube to ensure that it is sealed against the stomach wall, and
not causing an outlet obstruction
- Check the measurement to ensure that the tube is not post pyloric
- Consider slowing the rate, (confirm with nutritionist)
- If patient has a GJ tube – this may indicate significant underlying problem and the
tube should be evaluated by fluoroscopy.
My tube looks infected… What do I do?
- Antibiotic creams can be considered, but not for >5days
- Determine nature of infection (purulent vs Candida) – Treat accordingly
- Warmed sterile saline and sterile gauze can be used as a compress TID if bacterial
infection is suspected.
- If symptoms persist, schedule an appointment to be seen by a doctor.
Common Gastrostomy Tube Management
Questions: A reference (cont’d)
My tube is leaking… What do I do?
- Upsizing the tube will usually only upsize the tract, and is not generally
recommended
- Check for residuals – you may be filling up a stomach that isn't emptying.
- Pull back gently on the tube to ensure it is snug to the stomach wall
- Tube may be cracked internally – consider fluoroscopic evaluation
- Check balloon to ensure that it is not deflated
- Barrier cream can be used to prevent skin breakdown
- PPIs can be considered to decrease acidity of leaked contents, Motility agents can
be considered to promote outflow and decrease pressure
My tube is clogging/is clogged … what do I do
- Warm the tube prior to administering meds by indwelling warm water
- Do not crush enteric meds and put them in the tube
- Fill the tube with 1-3ml of carbonated water, dwell for 5 minutes, gently massage
tube, then attempt to flush and aspirate
- Pancreatic enzymes can be used if the patient is in house.
My tube just fell out … what do I do?
- If the tract is immature (<6weeks) – go to the ER to be evaluated
- If the tract is matured, a Foley can be placed that is 1fr size smaller than the initial G
Percutaneous Nephrostomy
Contraindictations
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Absolute
– None
Relative
– Uncorrectable bleeding
diathesis or coagulopathy
– Terminally ill patient to which no
quality of life benefit is expected
(tube management is difficult)
– Pregnancy (radiation risk)
Success rates
• Success rates generally vary by clinical scenario and operator,
however here are the broadly generalized success rates by
scenerio and threshold to maintain certification:
Complication Rates and Threshold
Common tube management
questions
1. When do I empty/change the bag?
- Empty the bag before it is completely full.
- Changing the bag is recommended only if there is leak or malfunction. The bag can
also be changed for cosmetic reasons.
2. Can I bathe or swim?
- Never submerge the tube. Sponge baths are recommended to keep the dressing dry.
3. Can I shower?
- You can take a shower if you put a plastic covering, such as Saran Wrap, over the
area.
4. When do I change the dressing?
- The dressing (gause) should be changed every 3 days or when it gets soiled, wet, or
loose.
– Tegaderm should only be changed once a week or when it becomes soiled, wet,
or loose.
Biopsies
Indications and Complications
Indications
Contraindications
• Complications vary highly by location and organ
• Contraindications: Always be sure that the biopsy will
change management in some way.
Success and Complication Rates
Globally, you can quote to
patients a 70-90% success rate
for any percutaneous biopsy
(excluding those not safely
accessable)
Hypervascular organs
(kidney/spleen) have 05.-2%
“significant” bleeding rate with our
traditional 19ga Temnos
Always consent for tract seeding
Transthoracic biopsy complications
Always consent for hemoptysis, pneumothorax, thoracostomy tube placement
with admission, and death. Significant lung injury requiring admission is
approximately. 2%
Source: SIR Guidelines for Percutaneous Biopsy
Tract Seeding
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Tract seeding rates are highly variable
based on primary tumor.
Data is mostly limited to case reports, and
large volume studies are lacking. Some data
is available, however:
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RCC risk has been estimated at 0.01%,
with only 5 reported cases between
1977-2013.
TCC (kidney) has an estimated rate of
3-5% seeding, and if TCC is
suspected; direct surgical excision is
recommended.
As of 2008, metadata for HCC biopsy
tract seeding approaches 2.7%.
Tract seeding after Perc Neph
Most of the data comes from extrapolated
data from HCC literature.
As evidenced by the ACR/SIR guidelines
on percutaneous biopsies: rates estimated
to be less than 3.4%
Specifically, large gauge needles, increased
number of needle passes into the mass,
end-cutting needles, and lack of a biopsy
sheath have been implicated in tumor
seeding of biopsy tracts
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McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med 2003;348:1123–1133.
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Major bleeding complication rate of ultrasound-guided paracentesis in thrombocytopenic patients S. Reardon, T.D. Atwell, A. Lekah Journal of vascular and interventional radiology : JVIR 1 April
2013 (volume 24 issue 4 Page S56 DOI: 10.1016/j.jvir.2013.01.129)
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Bernardi, Mauro, Caraceni, Paolo, Navickis, Roberta J. Wilkes, Mahlon M. Albumin infusion in patients undergoing large-volume paracentesis: A meta-analysis of randomized trial HepatologyVL 55, IS - 4
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Jones PW, Moyers JP, Rogers JT, Rodriguez RM, Lee YC, Light RW. Ultrasound-guided thoracentesis: is it a safer method?
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Wojcik R, Cipolle M D, Fearen I, et al. Long term follow-up of trauma patients with a vena caval filter. J Trauma. 2000;49:839–843.
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Grande W J, Trerotola S O, Reilly P M, et al. Experience with the Recovery filter as a retrievable inferior vena cava filter. J Vasc Interv Radiol. 2005;16:1189–1193.
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Lin, M; Soo, T, Horn, L Successful Retrieval of an infected Gunther Tulip IVC filter. JVIR 2000;11:1341–1343
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Kalambokis G, Manousou P, Vibhakorn S, Marelli L, Cholongitas E, Senzolo M, et al. Transjugular liver biopsy--indications, adequacy, quality of specimens, and complications: A systematic
review. J Hepatol. 2007;47:284–94.
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Yavuz K, Geyik S, Barton RE, Petersen B, Lakin P, Keller FS, et al. Transjugular liver biopsy via the left internal jugular vein. J Vasc Interv Radiol. 2007;18:237–41.
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Mammen T, Keshava SN, Eapen CE, Raghuram L, Moses V, Gopi K, et al. Transjugular liver biopsy: A retrospective analysis of 601 cases. J Vasc Interv Radiol. 2008;19:351–8.
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Dinkel HP, Wittchen K, Hoppe H, Dufour JF, Zimmermann A, Triller J. [Transjugular liver core biopsy: indications, results, and complications]. Rofo. Aug 2003;175(8):1112-9.
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Kalambokis G, Manousou P, Vibhakorn S, et al. Transjugular liver biopsy--indications, adequacy, quality of specimens, and complications--a systematic review. J Hepatol. Aug 2007;47(2):284-94.
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B Dhvasari, Intrahepatic delivery of feeds caused by a displaced percutaneous radiological gastrostomy catheter BJR March 1,
2009 vol. 82 no. 975 e48-e50
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Thornton F J, Fotheringham T, Haslam P J, et al. Percutaneous radiological gastrostomy with and without T-fastener gastropexy: a randomised
comparison study. Cardiovasc Intervent Radiol. 2002;25:467–471
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Iilva MA, Hegab B, Hyde C, Guo B, Buckels JA, Mirza DF. Needle track seeding following biopsy of liver lesions in the diagnosis of hepatocellular cancer: a systematic
review and meta-analysis. Gut. 2008;57:1592–1596.
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ACR guidelines for percutaneous nephrostomy http://www.acr.org/~/media/ebd04ede1f9b4a759eb253f65e5964ab.pdf
ACR guidelines for percutaneous biopsy
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Lyon, S Percutaneous gastrostomy and gastrojejunostomySemin ntervent Radiol. 2004 September; 21(3): 181–189
Chest. 2003 Feb;123(2):418-23.
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