Extracorporeal Shock Wave Lithotripsy for Retained Bile Duct Stones
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678 Gut 1997; 40: 678-682 Fluoroscopically guided laser lithotripsy versus extracorporeal shock wave lithotripsy for retained bile duct stones: a prospective randomised study Gut: first published as 10.1136/gut.40.5.678 on 1 May 1997. Downloaded from R Jakobs, H E Adamek, M Maier, M Kromer, C Benz, W R Martin, J F Riemann Abstract of stones mechanical lithotripsy is the first line Background and aims-To compare ex- treatment with a therapeutic success of about tracorporeal shock wave lithotripsy 80% to 97% and the best reported cost (ESWL) and laser induced shock wave effectiveness. This method fails in a few lithotripsy (LISL) of retained bile duct patients because the calculi are too large, stones to stone free rate, number of impacted, or located above a biliary stricture.5 therapeutic sessions, and costs. Biliary stones are resistant to the above Patients-Thirty four patients were ran- methods in only 2% to 5% of patients. For domly assigned to either ESWL or LISL this selected group extracorporeal and various therapy. The main reasons for failure of intracorporeal lithotripsy procedures were standard endoscopy were due to stone developed over the past decade."5 Laser impaction (n=12), biliary stricture (n=8), lithotripsy is the latest development in the field or large stone diameter (n=14). of fragmentation techniques. A major problem Methods-An extracorporeal piezoelec- in using this device is the requirement of tric lithotripter with ultrasonic guidance cholangioscopic guidance, which is expensive and a rhodamine 6G laser with an in- due to the cost of the cumbersome endoscopic tegrated stone tissue detection system equipment and the need for two experienced were used. LISL was performed exclus- endoscopists operating the "mother and baby" ively under radiological control. endoscope.9 The most promising laser litho- Results-Using the initial methods com- tripter has an integrated stone tissue detection plete stone fragmentation was achieved in system,10 which can be used under sole flu- nine of 17 patients (52.4%) of the ESWL oroscopic guidance and thereby should reduce http://gut.bmj.com/ group and in 14 of 17 patients (82-4%) in the expense of this means of fragmentation. the LISL group, or combined with ad- The aim of our prospective trial was to ditional fragmentation techniques 31 of compare ultrasonically guided extracorporeal the 34 patients (91 2%) were stone free at shock wave lithotripsy (ESWL) with laser the end oftreatment. In comparison LISL induced intracorporeal lithotripsy (LISL) tended to be more efficient in clearing performed under pure radiological control, the bile ducts (p=0.07, NS). Significantly chiefly with respect to stone free rates, but also on October 2, 2021 by guest. Protected copyright. less fragmentation sessions (1-29 v 2-82; the number of endoscopic sessions necessary p=0O0001) and less additional endoscopic for therapeutic success, the side effects, and sessions (0.65 v 1'6; p=0.002) were necess- costs. ary in the LISL group. There were no major complications in either procedure. Conclusions-Compared with ESWL, flu- Methods oroscopically guided LISL achieves stone Over a two year period 34 patients with com- disintegration more rapidly and with sig- plicated bile duct stones were prospectively nificantly less treatment sessions, which and randomly enrolled in the study (Table I). Department of leads to a significant reduction in cost. Inclusion criteria were as follows: (1) Medicine C, Klinikum (Gut 1997; 40: 678-682) choledochal lithiasis, diagnosed by means of Ludwigshafen, endoscopic retrograde cholangiography, (2) Academic Teaching Hospital ofthe Keywords: laser lithotripsy, extracorporeal shock wave detection of the bile duct stones by abdominal University ofMainz, lithotripsy, retained bile duct stones, endoscopic ultrasound, (3) papilla within reach of the Ludwigshafen, retrograde cholangiopancreatography. Germany R Jakobs H E Adamek TABLE I Patient's characteristics according to the two M Maier Since the introduction of endoscopic sphinc- treatment groups M Kromer terotomy in 1974,' 2 endoscopy has been C Benz ESWL LISL W R Martin widely used in the treatment of common bile J F Riemann duct stones. Particularly in elderly patients, Patients (n) 17 17 Sex 11 F 11 F Correspondence to: after previous cholecystectomy and before 6M 6M Dr RalfJakobs, laparoscopic cholecystectomy, endoscopic bile Mean age (range) (y) 72 (39-92) 72 (29-86) Department of Medicine C, Previous cholecystectomy (n(%)) 7 (41) 7 (41) Klinikum Ludwigshafen, duct clearance is preferred.3 Successful re- Symptoms on admission: Bremserstrasse 79, D-67063 moval of bile duct stones by standard endos- Painless jaundice 6 3 Ludwigshafen, Germany. Colic with or without icterus 6 8 Accepted for publication copy was achieved in 85% to 95% of patients Cholangitis 5 6 23 January 1997 in several series.4 For the remaining 5% to 15% Fluoroscopically guided laser lithotripsy versus extracorporeal shock wave lithotripsyfor retained bile duct stones 679 TABLE II Stone properties in the two treatment groups by was achieved extraction of fragments was endoscopic retrograde cholangiopancreatography radiograph attempted via endoscopic retrograde cholan- ESWL LISL giopancreatography. If sufficient fragmen- tation was not achievable after three ESWVL Stone diameter (mm)* 25 (8-30) 24 (12-38) Number of stones: sessions an alternative fragmentation tech- 1 6 5 nique was performed. Gut: first published as 10.1136/gut.40.5.678 on 1 May 1997. Downloaded from 2 5 3 >2 6 9 For LISL we used the Xenon flashlamp Stone position: pulsed rhodamine 6G laser with an integrated Hilum (and adjacent hepatic ducts) 4 3 Upper half of the CBD 4 6 stone tissue detection system (Lithognost, Carl Prepapillary half of the CBD 9 8 Baasel Lasertechnik, Starnberg, Germany). Concomitant bile duct structure 5 5 The stone tissue detection system, as described *Stone diameter=maximal stone diameter in case of more than elsewhere,'0 is based on the analysis ofthe back one stone. scattered laser energy. If the intensity of the CBD=Common bile duct. light is below a defined threshold level, it indicates that the glass fibre is not in contact with a bile duct stone and the laser pulse is cut endoscope, (4) failure of standard endoscopic off with the aid of a polariser preventing tissue extraction manoeuvres including endoscopic from being damaged." sphincterotomy and at least one attempt at The laser glass fibre (250 ,um or 300 pum mechanical lithotripsy, (5) the patient's in- core diameter) was inserted in a 5 Fr or 7 Fr formed consent. gauge Huibregtse or balloon catheter and Patients were excluded from the study if passed through the papilla via the working they had major coagulation problems, were channel of a standard duodenoscope (Olympus pregnant, or if one of the inclusion criteria was JF 1-T20). As the laser fibre itself is not not fulfilled. detectable by fluoroscopy the metal tipped All patients were diagnosed as having bile catheter was positioned in close proximity to duct stones by endoscopic retrograde chol- the stone and then the fibre was gently pushed angiopancreatography at our institution or at out of the catheter. Treatments were per- the referring hospital. Data regarding stone formed at an energy level of 100 to 150 mJ per size, number, and location were based on the pulse at a repetition rate of 8 to 10 Hz. During endoscopic retrograde cholangiopancreatogra- the laser treatment the fragmentation effect phy radiograph (maximum stone size was was monitored by fluoroscopy after instillation measured based on the diameter of the of contrast media into the bile duct. endoscope). Table II gives the properties ofthe LISL was limited to three treatment sessions stones. with a maximum duration of 45 minutes. After failure of at least one attempt at Laser therapy was discontinued if there was no http://gut.bmj.com/ mechanical lithotripsy a nasobiliary drain was fragmentation effect, when the stones could inserted and the patients were randomly not be correctly targeted by the laser fibre, or assigned to ESWL or LISL. The main reasons if they were not detectable by the integrated for failure of standard endoscopy were stone stone tissue detection system. impaction (n=12), biliary stricture (n=8), or In the case of failure of the initial treatment large stone diameter (n= 14). patients were switched to an alternative method All extracorporeal and intracorporeal treat- (LISL, ESWL, or electrohydraulic lithotripsy. on October 2, 2021 by guest. Protected copyright. ment sessions were performed under intra- For electrohydraulic lithotripsy we used the venous sedation (2 to 5 mg midazolame) and Lithotron EL-23 (Walz Electronic, Rohrdorf, additional analgesia if necessary (25 to 100 mg Germany) under strict cholangioscopic control. pethidine). Patients were monitored by clinical observation and continuous pulse oximetry during the procedures. STATISTICAL ANALYSES Data were entered into a database program and statistics were calculated with a statistical METHODS software package (Unistat 3 0 for Windows; ESWL was performed with an ultrasonically Unistat Co, UK). Values are expressed as guided piezoelectric lithotripter (Piezolith median (range) or mean (SD), unless other- 2300, R Wolf, Knittlingen, Germany). Stones wise stated. A Mann-Whitney U test or two were located with the two integrated 4 MHz tailed Fisher's exact test was used for com- ultrasound scanners and the shock wave focus parison between the two groups. A p value energy was increased from a minimum of 600 <0 05 was considered to be significant. bar to the highest tolerated energy level (maximum 1200 bar). During the ESWL session the bile duct was irrigated continuously Results with saline solution through a nasobiliary ESWL GROUP drain. Bile duct concrements of all patients (17) were Patients were treated with a maximum 5000 visible by the integrated ultrasound scanner pulses per session. Fragmentation effects were before therapy. Patients were treated with a controlled by abdominal ultrasound after each mean of 2-82 (1-24) ESWL sessions cor- session.