VOICE OVER: Prior to the procedure a patient, a 50-year old woman, with a solitary cholesterol stone measuring 14 millimeters, was brought to the treatment room and the technologist performed a pretreatment ultrasound. The patient is positioned on the table with her abdomen over the shock wave aperture.

ERTAN: The patient is comfortable and when we're ready, we're going to start IV on analgesia with IV Propofol. Our patient's name is Arlene, a young lady with a single stone, now on the table. She's already elected for this study with a functioning gallbladder, and her gallbladder has a single stone, non-calcified, and the gallbladder wall by ultrasound is completely within normal limits, so she is an ideal patient for extracorporeal shock wave lithotripsy. We explained to her in detail about the pros and cons of this procedure and she is going to have this nonsurgical modality. She's lying on this dry table. There is a little window. Her right upper quadrant is in that area, and Mr. Canny is putting the coupling fluid there. It's very important to put the patient's right upper quadrant to that window very tight without any air bubbling in order to have less pain and also more effective lithotripsy. So this is the ultrasound probe, and we have here 6 lights (LED'S) with the shield. This LED is going to carry the image to the cameras at the ceiling. And the patient is very comfortable. And now we are starting IV analgesia. The stone is there with the gallbladder image. This is exactly what you see in the ultrasound screen.

Now, we're going to put the patient in proper position with the computer's help. Table came up, go to the left side, to the head side, and we put the stone in F2 point and we confirm our positioning.

VOICE OVER: The computer triangulates the stone location, and the motorized table is automatically posititioned to bring the stone into the focal zone. At this point, Dr. Ertan will initiate treatment.

ZABBO: Watch the patient when this happens, too. If the patient jumps and she's moved, obviously, she's moved that stone out of the shock wave focus. She's filling with water and then she'll start shocking.

ERTAN: We are filling up the column with the water.

ZABBO: The beauty with ultrasound is you can continuously monitor as opposed to x-rays in radiology. We can localize the stone, give 500 shocks and go back to look and see if it's still there.

ERTAN: The only discomfort they have, a banging sound sometimes, and also just a pushing effect. An actual pain should not be felt.

ZABBO: To put your hands around it, I think the level of discomfort that they're feeling is about the same as if somebody flicked your ear real hard. You could tolerate that if somebody did it four or five times, but you do it two or three thousand times it gets a little annoying. You actually can see the stone moving a bit.

ERTAN: The Stone is nicely affected by shock waves. It is already starting to fragment it. But we have some time to go. The most of the things you see in the extra shock wave lithotripsy ultrasound screen, are effects. Some of the stone related action is due to shock wave effect in the stone. That single stone at this time after 178-179 shock waves is already fragmented, and we're going to work on these fragments, make these fragments as little as 2-3 millimeter to allow the fragments to pass by the cystic duct, also the ampulla (Sphincter of Oddi), and at the same time the fragments are going to have the benefit of being dissolved by deoxycholic acid which is going to be complementary to this.

Now, we are in the 500 range. We will stop firing the shock waves at this point and we will relocalize the patient. Especially in the early training stage, and even later on, this is a very important point. Although with IV analgesia this is a painless procedure, patients still move consciously or unconsciously, so to prevent the problem (because when a patient moves, F2 point might be out of our focus), we have to go and relocalize and have a few more minutes to do that to have more effective extra corporeal shock wave lithotripsy.

ZABBO: There is a reduction in the size of the stone already.

ERTAN: The largest fragments we can see right now are possibly 4-5 millimeters. As you see, the body of the gallbladder shows a very good outcome at this early stage. But, again, we're going to try to decrease the size of the fragments for easy passage. For easy passage we really need 2-3, not more than 5 millimeter fragments.

Our anesthesiologist is here and we are following all the vital signs according to guidelines outlined, and we have all the vital signs under control.

ZABBO: One of the things that we've mentioned before is be careful of any cardiac arrhythmia's. I assume that none have been seen on the monitor as yet.

ERTAN: We are looking at the EKG and the EKG looks like a baseline EKG.

ZABBO: Dr. Ertan, once the stone has been fragmented, do you then move and try to pick up the other fragments to treat those?

ERTAN: Yes. We have a 2,000 limit and sometimes you might stop at 1,000 or 1,500 but usually, like you already alluded to, if the stones are fragmented we go to the largest fragment and try to make it smaller. If the fragments are small, as small as possible, the success rate is going to be much better. So we did around 850 shock waves right now and we will relocate the patient after 1,000 shock waves.

UNKNOWN SPEAKER: There was a question as to how do you know what your end point is for treatment?

ERTAN: Very good point. I think you have to use common sense and check the gallbladder one more time. If the stones are less than 3 millimeters or 4 millimeters you might stop there, but sometimes it might be misleading to you because there is a lot of dust there and that might mislead you into miscalculating the end point, so I personally go and use 1,500, 2,000 to be satisfied. Where are you going to stop? First of all, you have to stop after 2,000 shock waves regardless, but in some certain patients with small stones, 7-8 millimeters, and if they are completely pulverized and if you cannot see larger than 3-4 millimeter fragments, you might stop even with 1,000 shock waves. In the ultrasound image we cannot see any fragments at this time but, again, it is very important to understand that gallbladder dust fragments might lead to miscalculation. So we will stop around 1,500 shock waves and then we will recalculate the F2 point and it may save time. This dust might be precipitated and then we can see if there is any more fragments that we may go and pulverize one more time with the remaining 500 shock waves.

I would like to re-emphasize one more time to check the F2 point at least every 400-500 shock waves. It is very crucial to have a successful outcome with this procedure. Please don't give all the shock waves all the way down up to 2,000.

Now, when we look at the ultrasound you see the dust a little bit precipitated and we still see some of the fragments but it appears to be none of them larger than 4 millimeters. We are relocalizing the F2 point, we're moving the table, and everything should come to .0 as shown here. We moved the patient a little bit right side down and front. The largest stone fragment appears to be in focus and is being reduced into little fragments, as little as possible and some of the fragments have already moved to the neck of the gallbladder and there is a layer of them in the distal portion of the gallbladder. Only dust size, possibly. We can barely see some fragments but, again, one point is very important: if the dust is there, all that sludge is there. Fragments might be misread and may stay in the dust area and you might miss the fragment. So when we stop the shock waves and the dust precipitates the distal portion of the gallbladder, as shown here, if there are any floating fragments you might see them. We are working very hard to find any fragment in this ultrasound screen. As you see, we don't have any yet, but let's work a little bit more hard. Yes, there is some fragments in the fundus of the gallbladder.

ZABBO: I would recommend that before the recovery room personnel discharge the patient that they do orthostatic blood pressure signs because once in a while you pick up somebody who might have some, in our case perirenal hematoma, in your case, perihepatic hematoma.

ERTAN: But, again, none of them appear to be more than 4-5 millimeters and, hopefully, we're going to make the size less than 4-5 millimeters because if the fragment is less than 4 millimeters they are going to be able to pass through the cystic duct more easily and with less pain. Then you can have a stone-free gallbladder. And the 10-11 millimeter gallbladder stone is almost completely fragmented and the largest fragment we can calculate is 3, possibly 4 millimeters. Still, we are working on those 3-4 millimeter fragments. As you see it moves with each shock wave as we are hitting that fragment as shown here. Some of the stones may have a very tight protein matrix, and might not be completely fragmented by this methodology. The ursodiol dissolving agent, hopefully, is going to work on that fragment and make the patient stone-free.

The fundus of the gallbladder is there. Some of the fragments are in the fundus, as shown here, and this is the neck of the gallbladder. The stone fragment is there, 3-3.5 millimeters by the ultrasound calculation. Even that fragment might be further fragmented and there is a large amount of dust in the gallbladder, and as you see in the distal portion of the gallbladder there is a large amount of the dust, fragments, small fragments, possibly a few millimeters at the most, and the largest fragment is still in the fundus of the gallbladder, but as you see, this is almost one-fourth of the gallbladder is filled with the dust and stone fragments. Some of them have acoustic shadowing, some of them no acoustic shadowing. I think this is satisfactory.