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1 All authors: Department of Radiology, Hospital General de Castelló, Avda. Benicasim, s/n. Castelló 12004, Spain.
Received October 9, 2003;
accepted after revision December 1, 2003.
Address correspondence to J. H. García-Vila.
Abstract
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MATERIALS AND METHODS. Between 1992 and 2001, we used this technique on 100 patients between the ages of 17 and 93 years (mean age, 68 years). The minimum diameter of the stones varied between 4 and 22 mm (mean size, 11 mm), and in 46 patients, only a single stone was seen. The stones were located in the common bile duct, and in 11 patients, intrahepatic stones were also observed. The approach was performed through a percutaneous biliary drainage tract in 48 patients, following the surgical tract of the Kehr tube in 36 patients, through a surgical transcystic drainage catheter in 10 patients, and through a percutaneous cholecystostomy in six patients.
RESULTS. The procedure was successful in 95% of the patients. The morbidity rate was 5%, and the procedure did not produce mortality in any of the cases. Eighty-nine patients required one session, 10 patients required two sessions, and the remaining patient required five sessions. The mean period of hospitalization after the procedure was 5.5 days (range, 1–40 days).
CONCLUSION. Balloon sphincteroplasty and transpapillary elimination of bile duct stones is an effective and safe technique.
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The treatment of most secondary calculi in the common bile duct consists of their surgical elimination at the time of cholecystectomy. Despite the fact that the use of intraoperative cholangiography and choledochoscopy have contributed considerably to improving their detection, the incidence of residual stones after surgery in the best series varies between 1.5% and 11% [1–4]. Since the 1970s, other techniques have become available that permit the nonsurgical treatment of biliary lithiasis. In regard to endoscopic therapy, the current method is sphincterotomy followed by the extraction of stones. Endoscopic extraction of the stones is accomplished with Dormia baskets, with a balloon, or by their spontaneous passage into the duodenum [4–6]. In regard to interventional radiology, the extraction of the stones is performed with Dormia baskets along the Kehr tube tract. This technique was made popular by Burhenne [7].
Nevertheless, another technique exists that, in our opinion, has not received the attention that it deserves in the field of interventional radiology and that offers unquestionable advantages. The aim of this study is to describe the usefulness of the dilation balloon sphincteroplasty and transpapillary elimination of calculi technique.
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Our approach was transhepatic in the 48 patients who had previously received a percutaneous biliary drainage catheter (Figs. 1A, 1B, 1C, 1D and 2A, 2B, 2C). In the patients who had a surgical biliary drainage catheter, the pathway in 36 patients was along the Kehr tube tract placed during open surgery and in 10 patients through transcystic catheters placed at laparoscopic cholecystectomy (Fig. 3A, 3B, 3C, 3D). In the six remaining patients, the same approach as that used in the percutaneous cholecystostomy was adopted (Fig. 4A, 4B, 4C, 4D).
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In every patient, cholangiography showed that there were stones in the common bile duct. Eleven patients also had stones in the intrahepatic bile ducts. In 46 patients, a single stone was seen; in 45 patients, two to four calculi were detected; and in nine patients, the number of calculi was impossible to define. The minimum diameter of the stones varied between 4 and 22 mm (mean, 11 mm).
The elimination of the calculi was performed between 2 and 45 days (mean, 13.5 days) after positioning the biliary drainage catheter, either surgically or percutaneously.
Technique
After monitoring the patient's vital signs (blood pressure, heart rate, and
O2 saturation levels), we applied a local anesthetic (lidocaine),
IV analgesic (fentanyl), and sedation (midazolam) in varying doses.
Prophylactic IV broad-spectrum antibiotics (ceftriaxone) were administered,
and the pancreas was protected with 0.25 mg of somatostatin or 0.1 mg of
octreotide. In addition, 1 mg of sphincter of Oddi's relaxant (glucagon) was
administered (the dose was repeated as needed).
The procedure began by replacing the drainage catheter with an 0.035-inch Amplatz super-stiff guidewire, with its distal tip in the duodenum and a vascular introducer with its distal tip in the common bile duct. The caliber of the introducer ranged between 8 and 10 French in most cases. Through the introducer, cholangiography with diluted contrast material was performed to show the number, location, and size of the stones, as well as the position of the papilla.
The next step involved dilation of the sphincter of Oddi with an angioplasty balloon (AXM, William Cook Europe) or a valvuloplasty balloon (VBC, William Cook Europe), 4 cm long with a diameter that varied between 6 and 23 mm (mean, 12 mm), depending on the size of the stone. The diameter of the balloon was slightly greater than the smallest diameter of the largest calculus. Once in place across the sphincter, the balloon was inflated until the waist disappeared (a pressure of 4–6 atm being usually reached), using a manometer to regulate the pressure and keeping it inflated during 30–60 sec. Dilation was then repeated.
After the sphincter was dilated, the angioplasty balloon was replaced by an occlusion balloon (POB-Weig, William Cook Europe). The caliber of the occlusion balloon was adjusted to the diameter of the common bile duct. After inflation, the occlusion balloon slides along the guidewire, pushing the stones toward the duodenum through the recently dilated papilla.
When the tract of the surgical bile drainage showed pronounced bends, first of all a hydrophilic angled guidewire of 0.035 inches (Nimble Roadrunner PC, William Cook Europe) was passed through the surgical drainage catheter. Then we replaced the drainage catheter with a multipurpose angled catheter (DAV Cerebral Davis TNB 5 F, William Cook Europe) with the tip in the duodenum. The next step consisted of turning and pulling the catheter to straighten the pathway. Finally, the hydrophilic guidewire was exchanged for an Amplatz super-stiff guidewire, and the multipurpose catheter was exchanged for a vascular introducer with its distal tip in the common bile duct (Fig. 3A, 3B, 3C, 3D).
The stones could be situated in the intrahepatic tract or proximally at the entrance of the introducer in the cases in which the approach adopted was performed through a surgical drainage catheter or through a percutaneous cholecystostomy. In these cases, spontaneous migration might occur after the sphincteroplasty. If this did not occur, using a multipurpose angled catheter, we directed a second guidewire toward the location to situate the occlusion balloon and drag the stones into the distal common bile duct. Finally they were pushed into the duodenum.
After the stones were eliminated, the introducer was exchanged for a prepapillary safety catheter (usually an 8.3-French Mueller biliary drainage catheter, William Cook Europe or a 12-French vanSonnenberg catheter, Boston Scientific Europe). This safety catheter was kept for external drainage, and the final cholangiography was performed through it 2–4 days later.
Success
We considered that the intervention was successful when the cholangiography
performed prior to removing the safety catheter showed that the biliary tree
was free of residual stone fragments or debris and flow of contrast material
through the papilla and into the duodenum was shown.
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The morbidity rate was 5%. Four patients had hemobilia and one patient had pancreatitis. Of the four patients with hemobilia, one underwent surgical intervention immediately, another was treated with a blood transfusion (3 U), and the other two required only clinical observation. The surgical patient was treated by transpapillary stone extraction through a duodenotomy, followed by gastroenterostomy. Active hemobilia during surgery was not detected. Clinical iatrogenic pancreatitis was only observed in one patient, requiring the parenteral administration of fluid therapy, analgesics, and somatostatin for 24 hr. There were no mortalities.
The number of sessions required was one in 89 patients, two in 10 patients, and five in one patient with multiple stones and postsurgical stenosis.
The mean hospital stay after the procedure was 5.5 days (varying between 1 and 40 days).
Long-term data were obtained retrospectively from chart review and referring clinicians. Information was obtained for 83 patients. The mean follow-up period for obtaining these data was 55 months, (range, 6 months–9 years). In none of the patients has a subsequent episode of cholangitis or of biliary obstruction been reported.
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The total elimination of calculi is achieved by endoscopic sphincterotomy in 80–90% of cases [6]. The usefulness and the success of this technique are clear because during the first 10 years after it was introduced, more than 50,000 interventions of this type were performed worldwide [6]. The morbidity rate is estimated to be less than 10%, varying in different studies between 2% and 13.5% [5, 6, 11, 12], and is greater in cases in which the bile duct is small [13]. The most serious complications are pancreatitis, hemorrhage, and perforation. The mortality rate is between 0% and 1.7% [5, 6, 11, 12].
In the removal of retained calculi with Dormia baskets through the trajectory of the Kehr tube, Burhenne [7] reported a success rate of 95% among a total of 661 patients. Other authors have reported similar results [14], with no mortality and a morbidity rate of approximately 4% [7, 14, 15].
The percutaneous extraction of stones in the bile duct with Dormia baskets implies using a working channel of similar diameter to that of the calculi that are to be removed or using fragmentation methods that complicate and increase the cost of the procedure. It is also necessary to have sufficient contrast material in the duct to visualize the stones so that they can be trapped. Furthermore, this technique also usually requires multiple sessions when multiple stones exist, and it is recommended that the procedure be delayed at least 4–6 weeks to allow a mature fibrous wall to develop along the tube tract. This facilitates percutaneous catheterization, avoids bleeding which occurs with a friable fresh tract, and prevents false passages [7–10, 14, 16–19].
In 1981 Centola et al. [20] described a case of transpapillary elimination of a stone by previously dilating the sphincter with a 6-mm balloon. In 1981 Mason and Cotton [21] and in 1983 Staritz et al. [22] referred to applying endoscopy to this technique in 12 patients with choledocholithiasis. Since then, a few sporadic cases have been reported in the radiology literature [23–25].
The technique we describe here permits us to treat very large stones with working tube diameters that are rarely greater than 4 mm and that eliminate all the stones in a single session (in our series, 55% of the patients had more than one stone, and only in 11% of the patients was more than one session required). Additionally, a long period of maturation of the tract is not necessary when adopting this approach (the mean catheter duration in our patients was 13.5 days).
The principal inconvenience of endoscopic sphincterotomy lies in the fact that it produces the definitive loss of sphincter function in most cases (this can be witnessed by the fact that 65% of the patients have pneumobilia after sphincterotomy) [5, 26], an event that can cause long-term complications. Morbid events, including papillary stenosis, recurrent biliary stones, and cholangitis induced by reflux, have been reported in 4–24% of patients who underwent sphincterotomy and have been followed up for up to 15 years [4, 5, 12, 26–28]. The search for a technique that is capable of achieving the same results, but more simply with a lower morbidity rate and maintaining the sphincter function has led to the rediscovery of balloon sphincteroplasty in recent years. Indeed, it is reappearing in the endoscopic literature, and there is now a body of work in the area of digestive endoscopy that proposes this technique as an alternative to the classic sphincterotomy [29–32].
Manometric studies have already shown the preservation of sphincter function in patients who undergo endoscopic balloon sphincteroplasty [30, 33, 34]. Also, experimental studies have been carried out in rabbits in which days after balloon sphincteroplasty, the recovery of sphincter function has also been shown [35]. In our study, on follow-up cholangiography, all patients had sphincters that contracted, and no patient had pneumobilia.
One of the differences among the studies published on endoscopic balloon sphincteroplasty is that the different authors systematically used 8-mm-diameter balloons and used mechanical lithotripsy when the stones were large [29–34]. In contrast, the size of the balloon that we used varied according to the transverse diameter of the largest stone, with a mean of 12 mm, and we did not resort to mechanical lithotripsy.
In our series, no cases of cholangitis were detected after the procedure, and only one case of mild pancreatitis was observed, although we do not screen all patients for chemical pancreatitis and only patients with clinical signs and symptoms of pancreatitis are identified. One of the factors that probably contributed to this low morbidity rate is the positioning of a safety catheter for the external biliary drainage. This catheter remains open, and it is later removed after performing a new control cholangiography, although this practice has the additional inconvenience of prolonging the process. In our series, the average stay in the hospital after the procedure was 5.5 days. In contrast, endoscopic sphincterotomy is currently performed as an outpatient procedure. However, it is common practice in Japan and other countries for patients to be hospitalized for many days after endoscopic sphincterotomy (the duration of hospital stays was not provided) [5, 6, 11–13, 26, 27, 30–34].
Pancreatitis is the most frequent and serious complication of endoscopic sphincterotomy and sphincteroplasty. One factor that could reduce the incidence of pancreatitis in our series is the absence of cannulation of the distal pancreatic duct using a radiologic approach. Another factor that could influence the reduced incidence of complications in our study is the systematic administration of pancreatic enzyme secretion inhibitors, such as octreotide or somatostatin. From the outset of our study, we have administered somatostatin, except during a period between 1995 and 1997 in which 32 patients were treated and to whom octreotide was administered. It seems that as well as inhibiting pancreatic secretion, somatostatin also provokes a relaxation of the sphincter of Oddi [36]. Conversely, it has been reported that octreotide (a synthetic analogue of somatostatin) can provoke spasms of the sphincter [37], spasms that have also been described as a paradoxical response to the administration of somatostatin [38]. Although we could not detect any differences between these two drugs in our hands, we decided to return to the use of somatostatin. During the procedure, we have always administered glucagon to produce a relaxation of the sphincter of Oddi.
In 48% of our patients, our approach was performed through a previously inserted percutaneous bile drainage catheter. This approach is, in most cases, through the left hepatic lobule and is guided by echography, given the indubitable advantages that this offers [39]. Although this is a less direct pathway than the right lobule, it is not usually a hindrance to the subsequent elimination of the calculi.
In the cases of residual lithiasis after laparoscopic cholecystectomy, a frequent problem that can be encountered is the existence of bends in the postsurgical drainage catheter, either in the Kehr tube (placed in cases of choledochotomy) or in the transcystic drainage catheter (placed in cases in which balloon sphincteroplasty is performed during the laparoscopic intervention). These bends are produced by not pulling the tube sufficiently at the end of the intervention when CO2 used for pneumoperitoneum is removed. These bends could be partially corrected if the percutaneous balloon sphincteroplasty is performed in the first 7 days after surgery. These bends make our approach more difficult and explain the failure in three of our patients.
In conclusion, balloon sphincteroplasty with transpapillary elimination of stones in the bile duct is an effective and safe technique for the treatment of this disease and with unquestionable advantages over the more usual procedures.
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