INFORMED CONSENT INFORMATION ADDRESSOGRAPH DATA CERVICAL MEDIASTINOSCOPY WITH BIOPSY You have decided to have an important procedure and we appreciate your selection of UCLA Healthcare to meet your needs. It is important to you and to us that you fully understand the risks, benefits and alternatives to the procedure you have planned. The purpose of this document is to provide written information regarding the risks, benefits and alternatives to this procedure. The information provided here is a supplement to the discussions you have had with your surgeon(s) in preparation for the procedure. You should read this material and ask your surgeon(s) any questions you have before giving your consent. The Procedure: You have a condition that requires visualization (mediastinoscopy) and possible sampling (biopsy) of the lymph nodes in the center portion of your chest (mediastinum). This is performed in the evaluation of cancers, infections, and other respiratory diseases. During the procedure, a rigid tube with a light and video camera (mediastinoscope) is inserted through a small 1 inch incision just above your breastbone and passed along the outside of your airway. Your surgeon(s) will obtain one or more biopsies, which is done with a miniature device specifically made to take a small sample from the desired lymph node(s). In some cases, your surgeon(s) may also pass the mediastinoscope between some of the large blood vessels to get to specific lymph nodes generally not available during a normal examination (extended mediastinoscopy). This is particularly useful in diseases involving the left lung. The procedure can last from 15 minutes to as long as 1-2 hours, depending on the individual patient’s circumstances. The procedure requires general anesthesia and is frequently performed as an outpatient procedure. Benefits Some benefits that may be gained from diseases involving your lungs and/or undergoing mediastinoscopy are listed chest which might not be detected by below. Your physician cannot guarantee any other test(s) and/or x-ray(s). you will receive any of these benefits. 2. Mediastinoscopy with biopsies may Only you can decide if the benefits are establish a diagnosis, which could worth the associated risk(s). substantially change your future treatment and prognosis. 1. Mediastinoscopy with biopsies may 3. Mediastinoscopy with biopsy, in yield important information about unusual cases, may improve airflow established and/or new (unsuspected) into and out of the lungs by removing 6/5/03 1 large fluid collections or masses that in better breathing following the compress the airway, thereby resulting procedure. Risks Before undergoing this procedure, a blood transfusion. If you require thorough understanding of the associated blood transfusion and have not risks is essential. The following risks are arranged to have your own blood well recognized, but there may be other stored ahead of time and available for risks not included in this list that are the procedure, the use of blood from unforeseen by your surgeon(s): designated or anonymous donors 1. Bleeding in the chest may occur could be necessary. If you receive this during or following the procedure. The type of blood, you could develop chance of bleeding increases if fevers (1 in 100), an allergic reaction multiple biopsies are performed. (1 in 100), red blood cell destruction or Although any bleeding that may occur “hemolytic reaction” (1 in 6000), usually amounts to only a few ounces hepatitis B (1 in 50,000), hepatitis C (1 (30-90 cc) of blood; in rare in 100,000), human immunodeficiency circumstances, bleeding can become viral infection or “HIV” (1 in 500,000), significant and life-threatening, other blood-borne infection, ie., requiring your surgeon(s) to make a syphilis, malaria, Chagas’ disease, large incision through your breastbone other viruses, etc. (1 in 1000), or a (median sternotomy) to stop the severe/fatal acute or allergic reaction bleeding. Occasionally, a small (1 in 100,000). amount of bleeding after the 3. Infections may develop following procedure along with swelling causes mediastinoscopy. Possible infections a lump to form under the incision. This include an infection in the incision, an slowly disappears a few days or up to infection of the major airways a few weeks following the procedure. (bronchitis) and an infection of the Bleeding is made worse by taking lung itself (pneumonia). Infections at aspirin, certain anti-inflammatory insertion sites of intravenous catheters medications (NSAID’s, ie, Advil, Aleve, (i.v.’s) also occur. These infections Vioxx, etc.), and blood thinners (ie, usually are accompanied by fevers coumadin, heparin, etc.). Generally, and either a cough productive of these medications should be stopped yellowish or green phlegm or pain, for a week prior to the procedure. If redness, and possibly drainage at the you are taking any of these incision or at the site of a intravenous medications, please inform your catheter. The treatment of these physician. infections is antibiotics with or without 2. If you have a bleeding problem, have expectorants. With treatment been on blood thinners essentially all infections can be cured. (anticoagulants), or have an anemia 4. Hoarseness may occur following the (low red blood cell count), it may be procedure and is normally due to necessary in rare cases to give you a irritation from the breathing tube used 6/5/03 2 for anesthesia. This lasts only a few abnormal heart beats. Most days. Very infrequently, the nerves arrhythmias that occur are easily going to your vocal cords, which run treated, are temporary (lasting only along side the airway can get minutes to hours), and are not stretched and damaged leading to necessarily an indication of a serious more significant hoarseness. Again, in underlying heart problem. In rare most instances, this is only temporary, circumstances, arrhythmias can lead lasting up to several weeks. Only to low blood pressure requiring the rarely is nerve damage permanent. If brief application of an amount of this occurs, your hoarseness can electrical energy to the heart almost always be improved with vocal (cardioversion) to stop it. If you have cord injections or implants, which severe heart disease, a heart attack or involves a procedure performed by stroke also could occur during or head and neck surgeons. immediately following the procedure, 5. Breathing difficulty with or without a although this is rare. low blood oxygen level may develop 7. Leakage of air from the lung or from during or following mediastinoscopy. the mediastinoscope into the sack This does not occur very frequently surrounding the lung with collapse of but is more likely if you have a pre- the lung (pneumothorax) occurs rarely existing breathing problem, ie., during or shortly following the asthma, emphysema, ªCOPDº, etc. procedure. This usually occurs You could experience wheezing following a biopsy. Many people have and/or chest tightness. During the no symptoms and the pneumothorax procedure you will be given additional is detected only by an x-ray, but some oxygen to breathe, and in simple patients develop mild to severe cases, medications to help your shortness of breath, particularly if breathing may be administered. If you there is a pre-existing lung problem. A develop serious breathing difficulty, small pneumothorax can be observed however, it may become necessary to and may need no treatment, but larger place a breathing (endotracheal) tube pneumothoraces and those associated into your airway to assist your with shortness of breath require a breathing. This could require hospital small tube to be placed through the admission and the use of a skin into the chest to remove the air. mechanical ventilator. This sometimes requires a hospital 6. Abnormal heart beats (arrhythmias) admission. can occur during almost any 8. Medication reactions occur only procedure done on the chest but are rarely during or following rare during mediastinoscopy. You are mediastinoscopy. The medications more likely to develop arrhythmias if commonly used are widely available you have had one previously or have and include lidocaine (similar to dental significant heart problems. If they do novocain), demerol or other morphine- occur, you may experience like drugs, midazolam or Versed palpitations and could require (similar to Valium), and medication to stop or control the metaproterenol or similar agent to 6/5/03 3 dilate bronchial airways. If you have cough and even hoarseness for one or an allergy to any one of these or more days. This is normal and usually similar types of medications, please is easily controlled by over-the-counter inform your surgeon(s) prior to the analgesics, such as acetaminophen procedure. If a reaction occurs, you (Tylenol). Sometimes a stronger could develop a rash, swelling, nausea medication may be necessary and a and/or vomiting, an unusual feeling, prescription for one will be provided for and even wheezing and/or shortness you by your surgeon(s). If you have of breath. A reaction is treated by had a biopsy, you should not use stopping any and all offending aspirin, anti-inflammatory medications medications, and, if necessary, by (NSAID's, ie, Advil, Aleve, Vioxx, etc.), giving you other medications to control or blood thinners (ie, coumadin, your symptom(s). heparin, etc.) unless specifically 9. Discomfort may occur following the approved by your surgeon(s). procedure. General anesthesia is used 10. Death. Life-threatening to eliminate any discomfort during the complications leading to death procedure; however following the following mediastinoscopy are very procedure, you may experience slight rare (<0.1%). throat discomfort with or without a dry Alternatives The alternatives to mediastinoscopy certainly far less accurate than those include the following limited options: obtained with mediastinoscopy. 1. Radiologic evaluation of the lymph 3. Close medical observation can be nodes can be accomplished with used to assess airway problems and computed tomography (CT or ªCATº), their developments over time without magnetic resonance (ªMRº), and invasive procedures, however, the positron emission tomography (PET) main risk of this approach is scans.