The Gallbladder : Shock Wave Lithotripsy, Surgery

by Food and Drug Administration (FDA)

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Shock Wave Lithotripsy

Shock wave lithotripsy, a noninvasive procedure that FDA approved for treating kidney stones in 1985, seemed to hold great promise for treating gallstones as well. (To treat kidney stones, the torso of the anesthetized but conscious patient is immobilized and lowered into a large tub of water, where x-rays are used to locate the stone and position the patient properly. In a procedure lasting one to two hours, the kidney stones are then crushed, without harming bone or soft tissue, by repeated shock waves from a generator at the bottom of the tub.)

"At the outset we thought, gee, it'll be great for gallstones, too. But gallstones turned out to be a whole different animal," says FDA's Mark Kramer, chief of the office of device evaluation's gastroenterology/urology branch I.

Not only are gallbladder stones chemically different from kidney stones, but kidney stones are easier to pass once shattered because urine forms in the kidney and collects in the bladder all the time. In contrast, the gallbladder squirts only intermittently, and may not contract and expand enough in patients who form stones for the stones to be passed. As a result, gallstone dissolution drugs usually must be taken along with the lithotripsy treatment. Based on the clinical data available, lithotripsy for gallstones may only work for 10 to 15 percent of sufferers, Kramer says, and it is not yet known which types of patients would benefit more from it than from drugs or surgery.

Surgery

Cholecystectomy — gallbladder removal — is the most common elective abdominal operation in western nations. Before the procedure was perfected a century ago, the cholecystostomies performed only removed the stones — which came back. Researchers then realized they had to remove the stones plus their pouch, the gallbladder. In a classical cholecystectomy, the surgeon removes the gallbladder through a 5- to 8-inch incision. The duct from the liver is then attached directly to the small intestine. Afterwards, a steady trickle of less concentrated bile is sent to the small intestine. In most cases, life returns to normal.

Cholecystectomy costs from $6,000 to $10,000, and requires a five- to seven-day hospital stay. The patient needs about a month to fully recover. Considering the invasiveness of the procedure, and that symptoms are often intermittent or even nonexistent, it is not surprising that the operation is declining in popularity. In 1975, 600,000 cholecystectomies were performed in the United States; by 1989, the number had dropped to 475,000.

A new surgical procedure, laparoscopic laser cholecystectomy (LLC, popularly known as "keyhole laser surgery"), is an alternative to conventional cholecystectomy. It is fast, effective, and far less invasive. A typical hospital stay is 36 hours or less, with return to normal activities within a week.

LLC requires four incisions: two half-inch-long cuts and two quarter-inch-long cuts. The laser energy is delivered along a tiny flexible quartz fiber through one of the larger openings, and is focused on a sapphire scalpel, which directly contacts the tissue. The scalpel channels the energy, minimizing damage to nearby tissue. A miniature TV camera is threaded through a tube called a laparoscope inserted in the second large hole. The two smaller holes permit entry of surgical instruments. The procedure can be performed by one or two surgeons.

Postoperative pain, if any, can be controlled with over-the-counter painkillers rather than the narcotics often needed following traditional cholecystectomy. This latest "band aid" surgery (so-called because it requires tiny incisions) promises to be particularly beneficial for the elderly.

"Older people often cough more frequently than others, and in the past, they have suffered badly with a large abdominal incision," says Phillip Rosett, M.D., who performs LLC at Thorek Hospital in Chicago.

"With the bigger incisions [of traditional gallbladder removal], older patients have a greater risk of developing pneumonia. They also have greater difficulty getting out of bed. It usually takes 24 hours before they can move from the bed to a chair and close to another 24 hours to start walking again. However, with LLC, my patients are up and walking the same afternoon, and they walk out of the hospital the following morning," he adds.

It's nice to know that gallbladder disease is one problem for which treatment is becoming both simpler and more successful. Although the answers aren't all in on what causes gallbladder disease, it couldn't hurt to follow the advice of the American Heart Association and the National Cancer Institute and add more fiber to our diets and cut back on fat.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.