5 Gallbladder stones: shockwave therapy MICHAEL

SACKMANN

RATIONALE FOR SHOCKWAVE GALLBLADDER STONES

THERAPY

OF

Cholecystectomy, the ‘gold standard’ of gallstone therapy for more than 100 years, has recently been modified by the application of laparoscopic techniques (Dubois et al, 1989; Perissat et al, 1989; Southern Surgeons Club, 1991). Like conventional cholecystectomy, the laparoscopic technique requires general anaesthesia and is associated with absence from work. It can be observed in nearly all fields of medicine that most patients will prefer the least invasive technique available to cure their disease. Thus, alternatives to cholecystectomy have been developed within the past several years. Oral bile acid dissolution therapy was introduced in 1972 as a completely non-invasive therapy (Bell et al, 1972; Danzinger et al, 1972). Ursodeoxycholic acid alone or in combination with chenodeoxycholic acid is used for dissolution of cholesterol gallstones. Oral administration of these bile acids causes few, if any, adverse effects. However, this attractive treatment is successful only in patients with very small stones and, even then, complete dissolution is obtained in only 40-70% of patients within l-2 years (Erlinger et al, 1984; Podda et al, 1989). Chaussy et al (1980) applied extracorporeally generated shockwaves for the disintegration of kidney stones. This offered a novel non-invasive treatment for stones in the human body. If gallstones are disintegrated by shockwaves into very small fragments, dissolution by bile acids will be accelerated owing to the enlarged surface of the stones, and spontaneous evacuation from the gallbladder is facilitated. Based on favourable results in animal experiments and in vitro investigations, in 1985 Sauerbruch and coworkers, together with engineers of Dornier, successfully applied shockwaves to gallstones (Sauerbruch et al, 1986). Since then, more than 40000 patients with gallstones have been treated worldwide by shockwave therapy. Thus, it seems justified to review the present state of gallbladder lithotripsy. ELIGIBILITY

OF PATIENTS

Entry criteria for shockwave therapy of gallstones have been introduced by our group (Sauerbruch et al, 1986; Sackmann et al, 1988, 1991a) and, with Baillikre’s Clinical GastroenterologyVol. 6, No. 4, November 1992 ISBN 0-7020-1625-X

697 Copyright 0 1992, by Baillitre All rights of reproduction in any form

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698

M.

SACKMANN

few exceptions, have been accepted by most other groups (Greiner et al, 1987; Branche and Magnier, 1989; Burnett et al, 1989; Mosnier et al, 1989; Ponchon et al, 1989; Vanderpool et al, 1989; Albert et al, 1990; Bory, 1990; Classen et al, 1990; El1 et al, 1990; Greiner and Jakobeit, 1990; Heinrich et al, 1990; Neuhaus et al, 1990; Schoenfield et al, 1990; Janowitz et al, 1991; Pelletier et al, 1991; Riemann et al, 1991; Torres et al, 1991) (Table 1). During a 5-year period, more than 5000 patients were referred to our department for the treatment of gallbladder stones. Of these, 19% fulfilled all entry criteria (Sackmann et al, 1991a). Othes have reported comparable percentages of suitability (Table 2). Major reasons not to treat patients are: (1) more than three stones; and (2) calcified stones (Sackmann et al, 1988, 1991a). Patients with single stones with a radiopaque rim were recently treated successfully by high-energy lithotripsy, and may thus be regarded as eligible for shockwave therapy, provided sufficient fragmentation of the stone is feasible (Sackmann et al, 1992a). In summary, about one fifth of patients with gallstones are eligible for gallbladder lithotripsy if relatively strict entry criteria (Tables 1 and 2) are fulfilled.

Table 1. Entry criteria for shockwave therapy of gallbladder calculi. 1. 2. 3. 4. 5.

History of biliary pain Single gallstone ~30 mm in diameter, radiolucent or with a radiopaque rim Two or three radiolucent stones with a total volume of 14 ml or less Visualization of the gallbladder on cholecystography No acute inflammation of the gallbladder, bile duct or pancreas; no obstruction of the biliary tree; no coagulopathy; no medication with anticoagulants or non-steroidal antiinflammatory drugs; no pregnancy 6. Identification of the stones in the shockwave focus

Table 2. Eligibility* Reference Brink et al (1989) Magnuson et al (1989) Meiser et al (1992)t Ponchon et al (1989) Rambow et al (1989)$ Rambow et al (1991)$ Sackmann et al (1991a) Stoelzel et al (1992)

of patients for shockwave therapy. No. of patients 100 100 133 531 200 486 5824 420

Suitability (%I 15 19 30 25 10 16 19 23

* The original ‘Munich’ criteria (Sauerbruch et al, 1986; Sackmann et al, 1988, 1991a; Table 1) were applied, with exclusion of radiopaque-rim stones. *Unimpaired contractility of the gallbladder and a total stone volume ~50% of the gallbladder volume with no upper limit on stone number were added as entry criteria in this study. $ Unimpaired contractility of the gallbladder and a density 3 mm left) varies considerably in the different studies (Table 3). With recent lithotripters, the shockwave source is coupled to the abdominal wall by a water cushion. To avoid gas-containing tissue being interposed, and to allow the stone to be as close to the shockwave source as possible, patients are treated preferentially in prone position with the shockwaves entering from below. Ultrasonographically guided, the stones are positioned into the focus. Gallbladder excursions caused by breathing may reach several centimetres, and the awake patient may occasionally move around on the treatment table. Thus, monitoring of the fragmentation by an experienced physician is required for successful fragmentation. An in-line ultrasound transducer mounted in the shockwave path is optimal for exact targeting. Shockwaves should be delivered only when the stones or fragments have been clearly identified in the shockwave focus. Depending on stone Table 3. In vivo disintegration of gallbladder calculi by shockwave lithotripsy. Fragmentation (% of patients) Largest fragment Reference

No. of patients

Bory (1990) Branche and Magnier (1989) Burnett et al (1989) Classen et al (1990) Darzi et al (1990a) El1 et al (1990) Frick et al (1991) Gagnon et al (1991) Greiner and Jakobeit (1990) Heinrich et al (1990) Janowitz et al (1991) Meiser et al (1992) Neuhaus et al (1990) Pelletier et al (1991) Rambow et al (1991) Riemann et al (1991) Sackmann et al (1991a) Schoenfield et al (1990) Stoelzel et al (1992) Vanderpool et al (1989) * Device: PE, piezoelectric hydraulic lithotripter.

101 160 223 216 21 100 74 243 612 530 124 220 40 363 80 65 711 600 97 52 lithotripter;

Device

‘Any’

GSmm

Gallbladder stones: shockwave therapy.

Within the past 7 years, gallbladder lithotripsy by shockwaves has been proven to be a safe and effective non-invasive therapy for selected patients w...
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