GASTROENTEROLOGY
1985:88:1807-11
Endoscopic Removal of Common Bile Duct Stones Through the Intact Papilla After Medical Sphincter Dilation MARTIN STARITZ, THOMAS PORALLA, HANS-HERMANN DORMEYER, and KARL-HERMANN MEYER ZUM BOSCHENFELDE First Department of Germany
of Internal
Medicine,
Iohannes
Recently, glyceryl trinitrate was shown to effectively dilate the smooth muscle of the sphincter of Oddi. This information was applied to endoscopic therapy of bile duct stones. In 21 patients a total of 32 common bile duct stones, 6-12 mm (X = 8.7 mm) in diameter, were removed through the intact sphincter after its medical dilation by administration of 1.23.6 mg glyceryi trinitrate. Thirty of 32 stones could be extracted without dificulty. The remaining two concrements had to be crushed by endoscopic mechanical lithotripsy before removal. No complications were observed during or after the procedure. Follow-up manometric examinations showed the papillary function to be well preserved. We therefore consider this new, safe, and easy method to be the treatment of choice for the removal of small- and medium-sized bile duct stones. Stones in the biliary tree, especially common bile duct stones, are still a major therapeutic problem. The incidence of retained common bile duct stones after cholecystectomy of 2%--6% (l-3)and the high frequency of complications associated with these calculi underline the need for a new and efficient form of therapy. Unfortunately, the therapeutic approaches known so far have some major limitations. Surgical therapy is associated with high morbidity and mortality (4,s) and oral or local dissolution therapy-even with improved detergents-is time consuming and often only partially successful, depending on the composition of the concrements (6).Therefore, endoscopic Received June 18, 1984. Accepted December 21, 1984. Address requests for reprints to: Dr. Martin Staritz, I. Med. Klinik und Poliklinik der Johannes Gutenberg Universitat, Langenbeckstrasse 1, D-6500 Mainz, Federal Republic of Germany. 0 1985 by the American Gastroenterological Association 0016-50851851$3.30
Gutenberg
University,
Mainz,
Federal
Republic
removal of common bile duct stones has attracted widespread attention during the last 10 yr (7,8). Nevertheless, because conventional endoscopic techniques require papillotomy, there is a risk of severe complications in -8% of patients (9). The recently developed endoscopic pneumatic papillary dilation method (10)apparently avoids some of the complications of papillotomy, but requires special equipment and an endoscopist experienced in this sophisticated technique. We therefore tried to improve on the endoscopic techniques available for the removal of common bile duct stones in terms of safety and ease of performance. The smooth muscle sphincter of Oddi is the major obstacle for common bile duct stones passing into the duodenum. Endoscopic manometric studies indicate that glyceryl trinitrate (GTN) has a remarkable dilating effect on the sphincter muscle. Three minutes after sublingual application of 1.2 mg GTN, the baseline pressure of the sphincter decreased from 8.9 + 0.6mmHg to 2.9 + 0.7mmHg (11). Based on these findings, we tried to remove small- and mediumsized common bile duct stones through the intact papilla after its GTN-induced medical dilation. The present paper describes the procedure, reports the encouraging results, and discusses its presumed clinical relevance.
Materials and Methods Diagnostic
Endoscopic
Procedure
Endoscopic retrograde cholangiopancreatography (Olympus JF 1 T, Olympus Optical Co., Tokyo, Japan) was performed using standard technique (7). For premedication, IO-15 mg diazepam and 40 mg butylscopolamine were administered intravenously. After retrograde opacifiAbbreviation
used in this paper:
GTN, glyceryl
trinitrate.
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ET AL.
GASTROENTEROLOGY
cation of the common bile duct (contrast material Rayvist 300, Schering AG, Frankfurt, Federal Republic of Germany), the size of the bile duct stones was estimated by using the diameter of the endoscope on the x-ray film as a reference.
Therapeutic
Endoscopic
Procedure
For medical dilation of the sphincter, 1.2 mg GTN (Nitrolingualspray, Pohl-Boskamp, Hohenlockstedt, Federa1 Republic of Germany) was sprayed sublingually and the common bile duct was intubated by a Dormia basket (Olympus FG 16 L). The dose of GTN appeared to be sufficient when the common bile duct could be intubated easily by the Dormia probe. Otherwise the application of GTN had to be repeated once or twice. During the time of the study we observed 2 patients in whom the Dormia probe could not be passed through the papilla even after application of a total of 3.6 mg GTN. These 2 patients were excluded from this study and underwent papillotomy. After introduction of the Dormia probe,into the common bile duct, the calculi were captured and extracted under endoscopic inspection of the papillary orifice. If this failed, the Dormia basket with the stone was pulled close to the tip of the endoscope, and the endoscope, together with the basket and the stone was removed, under fluoroscopic control by applying moderate traction power. If the concrement was too large to pass the sphincter, it was shattered by a mechanical lithotriptor in the common bile duct as described elsewhere (12,13). Thereafter, the fragments were extracted as described above until repeated fluoroscopic examination proved the bile duct to be clear. After the procedure all patients underwent a 5-h fasting period and remained in the hospital for at least 3 days. In all patients a follow-up examination was performed 5-10 days later. We found one single concrement (diameter 7 mm) that had been overlooked the first time. It was easily removed in the same way. The papillary function before and 8-10 days after the treatment was studied in 6 patients by endoscopic papillary and common bile duct manometry (11,14-16). For this purpose a triple-lumen catheter (diameter 1.6 mm, Meditech, Watertown, Mass.) was introduced into the papillary orifice. The catheter was perfused by 0.2 ml saline/min using the capillary hydraulic perfusion pump according to Arndorfer et al. (17). Pressures were obtained by Statham elements (Beckman R 427 G, Beckman Instruments, Inc., Berkeley, Calif.) and registered by a writer (Beckman R 511 A). The papillary motor activity was described by the papillary contraction frequency and the For estimaamplitude as described elsewhere (11,14-16). tion of the common bile duct pressure and the papillary residual pressure, the duodenal pressure at the site of the papilla was taken as zero-reference. The endoscopic manometric examination was performed under standard conditions before the injection of contrast medium.
Patients Twenty-one patients (6 men, 15 women, mean age 58 yr) with a total of 32 common bile duct stones 6-12 mm
Vol. 88, No. 6
in diameter were included in the study. Five patients presented with retained concrements after recent cholecystectomy. In 13 patients cholecystectomy had been performed l-12 yr before the study. In 3 patients the gallbladder was still in situ, but showed no concrements.
Statistical
Analyses
The motility parameters of the sphincter obtained before and 8-10 days after stone removal were compared by the Wilcoxon-Mann-Whitney test.
Results Removal
of Common Bile Duct Stones
Twenty-eight of the 32 concrements could be easily extracted under direct endoscopic inspection of the papilla after application of GTN. Twenty patients received 1.2mg GTN and in 1 patient the removal of four stones required the administration of a total of 3.6 mg GTN. The diameters of the extracted concrements ranged from 6 to 12 mm (X = 8.7 mm). In 2 patients two single concrements 10 mm in diameter were removed by applying moderate traction on the endoscope, which caused the patients no discomfort. In 2 additional patients with calculi of lo- and 12-mm diameter, however, application of traction caused pain, and mechanical lithotripsy was preferred. Thereafter the fragments of the calculi were removed as described above. No complications were noted during the procedure, nor in a 3-day follow-up period. No patient developed abdominal discomfort, fever, jaundice, or biochemical signs of cholestasis or pancreatitis. Three of the patients complained of headaches after the GTN application and were treated with appropriate tnedication. In 1 patient minute amounts of blood were seen oozing from the papillary orifice after the removal of a rough-surfaced concrement 8 mm in diameter.
Follow-Up
Examinations
All patients underwent endoscopic and radiographic follow-up examinations of the papilla and the bile duct after a l&-l&day period. No evidence of ampullary pathology was found. One patient is used as an example (Figures 1 and 2). Endoscopic
Manometric
Findings
Before removal of the common bile duct stones, the papillary contraction frequency obtained in 6 of the patients was 5.8 ? 0.2 (mean * SEM) contractions/min (Figure 3), the contraction amplitude was 67.0 * 2.8 mmHg (Figure 4), the papillary
Iune 1985
SPHINCTER
DILATION
FOR GALLSTONE
REMOVAL
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min-1 before
1
after
6
4 5
I .-----5.& 0.22
57~0.22
4x2 SEM
Figure
3. Papillary contraction after stone removal.
frequency
before
and 8-10
days
residual pressure was 6.3 t 1.2 mmHg (Figure 5), and the common bile duct pressure was 11.0 k 1.3 mmHg (Figure 6). The findings 8-10 days after stone removal were very similar (NS), with the exception that the common bile duct pressure had decreased to 8.7 -f- 0.4 mmHg (p < 0.005). This latter figure and the results of the papillary motility were found to be within the range of a healthy control group studied previously (11).
Figure
1. Bile duct stone captured in the Dormia basket (arrow] which has been introduced after papillary dilation by glyceryl trinitrate administration.
Discussion The administration of 1.2-3.6 mg GTN permitted the endoscopic removal of small- and medium-sized bile duct stones through the intact and only temporarily dilated bile duct sphincter. The procedure described above was very simple for the endoscopist familiar with conventional endoscopic methods. Our experience with this procedure suggests that it is relatively safe. The follow-up examinations proved that the stone removal did not impair papillary functioh. Endoscopic papillotomy has been a great step forward in the removal of common bile duct stones when compared with surgical treatment, which has a fourfold higher mortality rate (4,5). This operative endoscopic procedure, however, was still burdened
mmHg
I
before
after
60 40 672 2.0 Figure
2. Follow-up examination of the patient shown in Figure 1 eight days after the stone removal. The biliary tree shows normal configuration. The papilla is patent (OrroW).
fii? Figure
4. Papillary contraction after stone removal.
66 + 3.7
SEM amplitude
before
and 8-10
days
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STARITZ ET AL.
GASTROENTEROLOGY Vol. 88, No. 6
mmHg after
0’ 6.321.2
6.32 1.0
$R+ SEM Figure
5. Papillary
residual pressure before and 8-10 days after stone removai.
by a complication rate of about 8% and a mortality rate of 1%~2% (9). Thus, endoscopic papillary dilation with a special balloon catheter (10) had been welcomed as an alterfiative to endoscopic pipillotomy. This procedure, however, requires special large-channel endoscopic equipment and is expensive due to the cost of the single-use bailoon catheter. In addition, the procedure requires sophisticated skill in endoscopic techniques. Jn contrast, stone removal after medical papillary dilation of the sphincter with GTN appears to bk a very successful procedure that can be performed safely, at lower cost, and without special equipment. Glyceryl trinitrate reaches its maximum plasma level -1-2 min after sublingual application (18). In our patients the dilative effect on the sphincter of Oddi-in some
mm Hg
before
after
patients mirrored by a visible widening of the papillary orifice or visible bile flow-was observed after a comparable period. Because GTN disappears from the blood rapidly at a half-life of -5 min (181, repeated application within intervals of S-10 min may be required for time-consuming procedures. On the other hand, the short half-life should prevent systemic accumulatiofi of the drug. Although the potential side effects of nitroglycerin such as tachycardia and hypotonia must be taken into account, none of our patients experienced Any complications, even after administration of 3.6 mg GTN. In recent decades GTN has proven to be a safe drug, and physicians are experienced in its administration to patients with coronary heart disease. Contraindications include shock and collapse, but such patients would not be candidates for endoscopy. Additionally, our own pilot study has proven that the application of GTN amounting to a total of 3.6 mg administered in 1%mg doses in 5-min intervals was without risk to the patients undergoihg endoscopic retrograde cholangioptincreatography under premedication, as mentioned in this paper. According to our experience, a single dose exceeding 1.2 mg GTN does not improve the dilative effect on the sphincter of Oddi, as shown in 2 patients in whom papillary intubation failed even after administration of 3.6 mg GTN. We therefore conclude that higher doses of GTN are only necessary in timeconsuming procedures such as extraction of several stones. In comparison with endoscopic papillotomy and the known methods for the removal of common bile duct stones, this new procedure is superior in terms of its simplicity, safety, and low cost. One of the major advantages, however, lies in the preservation of the sphincter function as demonstrated manometrically in all 6 patients studied 8-10 days after medical sphincter dilation. In our opinion this endoscopic procedure should be adopted as the treatment-or the therapeutic attempt-of choice for the removal of small- and medium-sized common bile duct stones.
14-
References
IZIO8-
8.1%0.4 (pc 0.005) f XZSEM
I 11?1.3
Figure 6. Common bile duct pressure before and 8-10 days after stone removal.
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