Balloon Dilation of the Native and Postsphincterotomy Papilla

Endoscopic sphincterotomy (EST; see Chapter 17 ) has become the procedure of choice for removal of stones from the bile duct, especially in postcholecystectomy patients. The procedure is successful in 90% to 98% of patients, and 86% to 91% of all bile duct stones can be extracted using EST and balloon/basket extraction.

In this chapter, we will discuss endoscopic balloon dilation with and without sphincterotomy. Small-diameter balloon dilation (≤10 mm) alone is performed in a different patient population (often young patients) for extraction of small stones, whereas large-diameter balloon dilation (≥12 mm), with or without EST, is performed for removal of large stones (often in elderly patients). Thus the risk profiles and techniques are markedly different.

Large stones, barrel-shaped stones, and tapering of the lower common bile duct (CBD) can make extraction difficult, and in such cases other techniques, such as mechanical lithotripsy, are required. The success rate for removal of large, difficult stones using EST and mechanical lithotripsy is 79% to 98%. However, EST is associated with adverse events such as bleeding, pancreatitis, and perforation (see Chapters 8 and 17 ), and concerns about permanent damage to sphincter function have led to the proposal and investigation of alternatives to sphincterotomy.

Endoscopic papillary balloon dilation (EPBD) is an alternative to EST for removal of bile duct stones. In an effort to avoid permanent destruction of the biliary sphincter, EPBD was suggested by early investigators, such as Staritz and Meyer zum Buschenfelde, who first reported it in 1983. EPBD is performed to enlarge the opening of the bile duct at the level of the biliary sphincter. The main advantage is avoidance of cutting the biliary sphincter. Therefore acute adverse events such as bleeding and perforation should be less likely, with preservation of function of the biliary sphincter.

The enthusiasm over the potential advantages of EPBD over EST for avoiding short-term adverse events of bleeding and perforation while preserving the biliary sphincter and possibly reducing the long-term sequelae of EST was soon dampened by reports of serious postprocedure pancreatitis (PEP). Therefore EPBD was nearly abandoned as a treatment for bile duct stones, but its use was revived with the development of laparoscopic cholecystectomy. With several groups reporting favorable results using EPBD for stone extraction, conservation of the biliary sphincter regained popularity in the 1990s. In 1995 Mac Mathuna et al. reported good results with EPBD for treating bile duct stones in 100 consecutively treated patients.

The results of subsequent randomized controlled trials comparing EST to EPBD are conflicting. Some authors have reported an increased incidence of PEP, whereas others have not, and an argument has been presented against EPBD and its failure to provide adequate access for extracting difficult (large or multiple) bile duct stones. The final success rates for EST and EPBD are comparable; the reported success rates of stone removal are 81% to 99% for EPBD and 85% to 98% for EST. Randomized trials comparing EPBD to EST suggest that EPBD is at least as effective as EST in patients with small to moderate-sized bile duct stones.

The lower rate of stone clearance, along with a higher usage of mechanical lithotripsy in EPBD, is most likely because EPBD does not enlarge the bile duct opening to the same extent as EST. Ersoz et al. reported the use of large-balloon dilation after EST for removal of bile duct stones that were difficult to extract by conventional EST and extraction devices. Endoscopic papillary large-balloon dilation (EPLBD) has been introduced as an adjunctive tool to EST for removing large or difficult CBD stones. The concept is to combine the advantages of sphincterotomy with those of balloon dilation.

However, EPLBD is still not fully accepted as some endoscopists are concerned about potentially serious adverse events such as pancreatitis and bile duct perforation. However, recent data from various multicenter studies in both Eastern and Western countries suggest that EPLBD with EST is safe and effective. Over the past 10 years, the technical methods and safety of EPLBD have been established and the indication has been expanded.

As an alternative method, EPLBD without a preceding EST was introduced as a simplified technique in 2009. Several studies have reported that this technique is safe and effective in patients with large bile duct stones, without an increased risk of severe pancreatitis or bile duct perforation, though these studies have been limited to patients outside of the United States and Western countries.

EPLBD After EST for Removal of Large Stones

To overcome the limitations of conventional EPBD, “large-balloon dilation after minimal biliary sphincterotomy” has been devised. Large-balloon dilation after minimal EST is effective for retrieving large biliary stones without the need for mechanical lithotripsy ( Figs. 18.1 and 18.2 ). Although EST with a large incision may be effective in reducing the need for mechanical lithotripsy, a large incision has a higher risk of perforation and possibly a higher risk of bleeding than standard EST. EPLBD combined with EST—an innovative, novel method incorporating slow dilation of the papilla to a large diameter—can provide a larger opening than a large EST (see Fig. 18.1 ) and prevent perforation and bleeding. Subsequent retrieval of large or multiple bile duct stones is easy, safe, and effective (see Fig. 18.2 ).

FIG 18.1, A case of large-balloon dilation after minimal EST in a patient with multiple large extrahepatic bile duct stones. A, Retrograde cholangiogram shows multiple large stones that completely fill the extrahepatic bile duct. B–D, After minimal EST, a large balloon is inflated up to 15 mm over the guidewire and through the sphincterotomized papilla. E, The papillary orifice is dilated fully and the bile duct mucosa is readily seen. EST, Endoscopic sphincterotomy.

FIG 18.2, A huge stone is impacted at the bile duct bifurcation. After sphincterotomy, large-balloon dilation is performed up to 18 mm. A and B, Removal with a large basket catheter and mechanical lithotriptor fails, and retrieval of a large stone is attempted with a retrieval balloon catheter (C) . D, The stone is pulled out with a retrieval balloon catheter and extracted from the papilla. E and F, A huge stone (4.5 cm × 2.0 cm) is finally evacuated without crushing.

Technique of Large-Balloon Dilation of Postsphincterotomy Papilla

Using a therapeutic duodenoscope (e.g., TJF 260V; Olympus Medical Systems, Tokyo, Japan), the endoscope is advanced to the duodenum. It is important to use a duodenoscope with a large working channel (4.2 mm in diameter) for easier passage of large balloons. The difference from conventional EPBD is that EST is performed before balloon dilation. In most cases a major (complete) EST is not required and a minimal (<1/3 of the maximum possible length) EST is sufficient. This is because the purpose of EST is not to dilate the sphincter of Oddi (SO) but to direct SO dilation toward the biliary side and away from the pancreas. When using a large-diameter balloon to dilate the SO without EST, it is difficult to predict the direction in which the SO will be dilated. Therefore, by performing a minimal EST, the direction of papilla dilation can be predicted. Another reason for minimal EST is to prevent PEP by minimizing peripapillary edema that may occur after dilating the papilla.

After EST, a guidewire is inserted into the bile duct and a balloon catheter is guided over the wire. By definition, EPLBD involves balloons of 12 to 20 mm in diameter. Because the maximum diameter of standard biliary dilation balloons are only 10 mm in diameter, pyloric dilating balloons such as the CRE Wire Guided Balloon (Boston Scientific, Marlborough, MA) are needed ( Fig. 18.3 ). Recently a combined sphincterotome with large-diameter balloon has become available (StoneMaster V; Olympus Medical Systems) so that EPLBD can be done with one device.

FIG 18.3, Dilating kit consisting of syringe/gauge assembly and inflation handle (A) and 6-mm to 8-mm, 8-mm to 10-mm, 12-mm to 15-mm, and 18-mm to 20-mm balloons (B).

The diameter of the dilating balloon is determined by the size of the bile duct stone and of the bile duct proximal to the tapered distal biliary segment. EST with a small incision up to the pancreatic orifice is performed over a guidewire. Endoscopic papillary dilation is performed slowly with a large balloon (maximum 20 mm in diameter) to match the size of the bile duct.

Although the balloon diameter for EPLBD ranges from 12 to 20 mm, a balloon with a diameter of 15 mm or less is frequently used to prevent serious adverse events, even if the bile duct stones are larger than 15 mm in diameter. Therefore the diameter of the distal bile duct may be regarded as a more important factor when selecting the balloon rather than the size of bile duct stones because excessive balloon dilation beyond the diameter of the distal bile duct may increase the risk of perforation. A large-scale retrospective multicenter EPLBD study of 946 patients with large bile duct stones (>10 mm) noted that the diameter of the inflated balloon used was larger than that of the distal bile duct in 2 of 3 patients with fatal perforation.

Dilation with large-diameter balloons is performed at the same session as EST. As mentioned, nonbiliary over-the-guidewire–type balloons intended for esophageal and pyloric dilation are used. The balloon catheters are passed over a guidewire and positioned across the biliary orifice; the middle portion of the balloon is gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to maintain the correct position and to observe the gradual disappearance of the waist in the balloon, which is taken to indicate progressive dilation of the distal bile duct and biliary orifice.

During EPLBD, rapid and forcible inflation of the balloon across a tight distal bile duct stricture can lead to perforation and bleeding. Obvious bile duct strictures are easily visible on cholangiography, whereas obscure bile duct strictures are sometimes difficult to diagnose.

The balloon should always be inflated slowly and gradually, starting from a smaller diameter than the intended maximal target, in order to recognize obscure bile duct strictures, with attention paid to the balloon shape under fluoroscopy.

If the central waist of the balloon does not disappear by 75% of maximal pressure prescribed for the particular balloon, the presence of an obscure stricture of the distal bile duct should be suspected and further balloon inflation should be halted to avoid perforation.

Once the waist has disappeared, the balloon remains inflated in position for 20 to 45 seconds, after which it is deflated and removed. A standard stone basket or retrieval balloon catheter is then used to remove the stones. In some cases, the waist in the balloon does not disappear completely; in such cases, keeping the balloon inflated for more than 45 seconds may be useful. Stones are then retrieved from the bile duct with a retrieval balloon catheter or a stone basket. After stone retrieval, irrigation of the bile duct with normal saline may help remove any remaining stones or fragments.

A dilation time lasting less than 1 minute may actually induce bleeding, which may be attributable to insufficient compression time by the balloon. After dilating the papilla for 1 minute, the balloon catheter is removed and a basket is inserted to remove the stone. Dilation with a large-diameter balloon after EST can be especially useful for clearing bile duct stones in patients with a tapered distal bile duct. By using a larger balloon, the distal duct can be shaped into a near square, facilitating stone removal.

Adverse Events of EPLBD After EST

Since 2003, there have been many reports on the outcomes and adverse events of EPLBD. Fortunately, most adverse events are mild and few serious adverse events have been reported, though there is a lack of large-scale multicenter randomized prospective studies.

A meta-analysis of randomized controlled trials that compared EPLBD and EST for retrieval of choledocholithiasis showed that EPLBD was associated with fewer overall adverse events than EST (5.8 vs 13.1%, OR 0.41, 95% CI 0.24 to 0.68, p = 0.0007).

A summary of multiple published series using only dilation balloons of >10 mm after EST for removal of bile duct stones is shown in Table 18.1 . Ten studies have been published as full papers in English, whereas four studies are preliminary reports. The reported stone removal success rates ranged from 73% to 100%, and the use of mechanical lithotripsy ranged from 1% to 33%. This wide range of lithotripsy use may be attributable to variable stone size and the diameter of dilation balloons used. The success rate of complete stone clearance in the first session in 1003 patients was 90.2% overall, and the use of mechanical lithotripsy was 11.6%.

TABLE 18.1

Summary of Reported Series of EPLBD After EST for Removal of Extrahepatic Bile Duct Stones

Series	No. of Procedures	Balloon Size (mm)	Mean Largest Stone (mm)	% Success in First Session	% Use of Lithotripsy	ADVERSE EVENTS, n (%)
Series	No. of Procedures	Balloon Size (mm)	Mean Largest Stone (mm)	% Success in First Session	% Use of Lithotripsy	Overall	Pancreatitis	Bleeding	Perforation	Others
Ersoz et al.	58	12–20	16/18 ^a	83	7	9 (16)	2 (3)	5 (9)	0	2 ^b
Minami et al.	88	Up to 20	14 ± 3	99	1	5 (6) ^c	1 (1)	1 (1)	0	1 ^b /1 ^d
Heo et al.	100	12–20	16.0 ± 0.7	97	8	5 (5)	4 (4)	0	0	1 ^b
Maydeo and Bhandari	62	12–15	16	92	5	5 (8.3)	0	5 (8.3)	0	0
Bang et al.	22	10–15	10 (5–25)	72.7	9	1 (4.5)	1 (4.5)	0	0	0
Misra and Dwivedi	50	15–20	NM (<15–25)	90	10	23 (46)	4 (8)	19 (38)	0	0
Attasaranya et al.	107	12–18	13 (10–30)	95	27	6 (5.6)	0	2 (1.9)	1 (0.9)	1 ^e /1 ^d /1 ^d
Kochhar et al.	74	10–18	NM (10–15)	91.9	2.7	16 (21.6)	2 (2.7)	6 (8.1)	0	13 ^e /1 ^d /1 ^d
Kim et al.	27	15–18	20.8 (≥15)	85	33	4 (15)	0	4 (15)	0	0
Kim et al.	72	12–20	NM	87.5	17.9	6 (8.3)	5 (6.9)	0	0	1 ^b
Yoo et al.	166	15–20	16.1 ± 5.4	83	NM	11 (6.6) ^f	NM	1 (0.6)	1 (0.6)	NM
Park et al.	70	15–20	NM (all >15)	100	16	13 (19)	3 (4)	10 (14)	0	0
Cho et al.	69	NM	17.5/18.2 ^g	91	NM	5 (7)	4 (6)	1 (1.4)	0	0
Cha et al.	38	15–20	18.9 ± 5.3	95	3	1 (3)	0	1 (3)	0	0
Total	1003	10–20	— ^h	90.2	11.6 ⁱ	110 (10.9)	26 (2.6) ^j	55 (5.5)	2 (0.2)	24 (2.4) ^j

EPLBD, Endoscopic papillary large-balloon dilation; EST, endoscopic sphincterotomy; NM, not mentioned.

a Median in two subgroups.

b Cholangitis or cholecystitis.

c Not including 10 patients who had hypotension after nitrate infusion (per protocol for prevention of procedure-related pancreatitis).

d Hypoxia, embedded broken basket, and intramural dissection.

e Abdominal pain.

f Two deaths from bleeding (1) and perforation (1).

g Mean in two subgroups with/without periampullary diverticulum.

h Cannot be calculated.

i Does not include Yoo et al. and Cho et al. series because of use of lithotripsy rate.

j Does not include Yoo et al. series because pancreatitis and other adverse event rates not specified.

The reported adverse event rate from published series has ranged from 1% to 23%, with a pancreatitis rate ranging from 0% to 5%. Analysis of all reported series showed a pooled adverse event rate of 10.9%, with a pooled pancreatitis rate of 2.6% (see Table 18.1 ). Most reported cases of pancreatitis were mild in severity. The pooled adverse event rate of this combined technique is similar to that after EST alone, with a mean overall adverse event rate of 8.2% and a pancreatitis rate of 1.9%. However, two deaths from severe bleeding and perforation were reported, which account for an overall mortality rate of 0.2% in 1003 patients.

Heo and colleagues from Korea randomized 200 consecutive patients with bile duct stones in equal numbers to EST plus EPLBD (12-mm to 20-mm balloon diameter) or EST alone. There was no difference in the rate of PEP. In a multicenter study, Attasaranya et al. reported potential efficacy of EPLBD using large-diameter balloons (≥12 mm) after sphincterotomy in 107 patients with large CBD stones at five endoscopic retrograde cholangiopancreatography (ERCP) referral centers in the United States. There were no reported cases of PEP. The absence of documented PEP in this study may be related to multiple factors. First, and perhaps most important, performing EPLBD after EST may decrease the risk of pancreatitis because the pancreatic orifice is separated from the biliary orifice after EST and the balloon dilation force will push the pressure away from the pancreatic duct. The significance of separated biliary and pancreatic orifices was reported by Mavrogiannis et al., showing that 81 patients with bile duct stones undergoing repeat EST had a significantly lower rate of pancreatitis than did 250 patients with initial EST (0% and 4.8%, respectively).

Second, this study included older patients with a mean age of 70.7 years, whereas the median age was 49 years in a prospective multicenter trial in the United States that showed a higher rate of pancreatitis after EPBD (small-diameter balloons and small stones). Subgroup analyses in one recent meta-analysis comparing EST with EPBD for bile duct stones demonstrated that age <60 years was one of the factors associated with a higher rate of pancreatitis in patients treated with EPBD. Age <60 years was also documented as one of the independent risk factors for ERCP pancreatitis in a prospective multicenter study.

Third, pancreatography was infrequently done in this study (14%). A small series showed that pancreatic contrast injection was the only single independent risk factor for pancreatitis in patients with bile duct stones treated with EPBD with a 6-mm to 8-mm balloon. One recent study including 14,331 ERCPs in a single referral ERCP center showed that there was a significantly higher frequency of PEP when pancreatic duct injection was performed.

Another hypothesis about the mechanism of pancreatitis after EPLBD has been suggested: the manipulation frequency of the Dormia basket and retrieval balloon catheter in EPLBD both with and without EST can be reduced because of a sufficiently widened ampullary orifice, resulting in less periampullary trauma and edema and a lower risk of pancreatitis. In contrast, the risk of injury to the ampullary orifice in EPBD by using small-diameter balloons may be increased because instruments for stone removal are passed through an inadequately widened ampullary orifice.

Bleeding occurs in 2% to 5% of patients undergoing EST to remove bile duct stones. In contrast, no significant bleeding has been observed after endoscopic balloon dilation. Misra and Dwivedi reported on EPLBD performed in India using 15-mm-diameter to 20-mm-diameter balloons in 50 patients after sphincterotomy. Minor oozing bleeding was seen in 16 patients (32%), but oozing stopped spontaneously during the completion of the endoscopy. Major bleeding requiring surgery occurred in one patient. Ersoz et al. reported three patients with moderate bleeding requiring blood transfusion and endoscopic therapy, which was thought to be attributed to EST, not balloon dilation. Although small-diameter balloon dilation alone is recommended by most experts as the treatment option for bile duct stones in patients with uncorrectable coagulopathy, whether large-diameter balloon dilation after (concurrent or remote) EST is as safe as small-diameter balloon dilation alone in terms of bleeding requires additional study. In fact, one death with bleeding has been reported, and bleeding requiring endoscopic therapy was noted in 8.3% of patients in another preliminary study. Use of large-diameter balloon dilation in patients with coagulopathy (even when using it alone in the setting of remote biliary sphincterotomy) should be undertaken cautiously.

In all six randomized controlled trials and three of four meta-analyses that were conducted to compare the clinical outcomes between EPLBD with EST and EST alone, the rate of bleeding was similar, whereas the remaining meta-analysis by Feng et al. found that the rate of bleeding was significantly lower for EPLBD with EST than that for EST alone. However, EST incision length is considered as the major factor of post-EPLBD bleeding, although the large dilation may result in tearing of underlying vessels. In a systematic review of 32 EPLBD studies, the rate of bleeding was significantly higher for EPLBD with large EST than for EPLBD with limited EST (OR 3.33, p < 0.001) or without EST (OR 2.17, p = 0.049). However, no significant difference in the bleeding rate was noted between EPLBD with limited EST and without EST ( p = 0.35).

In a multivariate analysis, the presence of a distal CBD stricture was an independent predictor of perforation, and Park et al. suggested that the presence of a distal CBD stricture should be considered a relative contraindication to EPLBD. In addition, they recommended gradual inflation, as well as caution, when a persistent waist at the distal CBD is identified after inflation to 75% of the manufacturer's recommended maximum inflation pressure ( Box 18.1 ).

Box 18.1

To Define Obvious or Occult Stricture of Bile Duct

The balloon should be inflated slowly in gradual steps.
Strong resistance and persistent waist during balloon inflation after applying 75% of the maximal inflation pressure. This should be used as the alarm sign.
Further forcible inflation of the balloon can induce bile duct perforation.

If strong resistance is encountered during balloon inflation, additional pressure should not be applied. In such cases, converting to alternative stone retrieval methods or providing drainage, with plans for repeat ERCP, is recommended. Large-balloon dilation should not be performed if the entire extrahepatic duct is small or normal in size. However, in all patients with large stones, the bile duct is dilated to at least the size of the stone.

Even if there is no obvious distal CBD stricture or tapered distal CBD after a cholangiogram, any marked resistance during balloon inflation or a distinct waist or severe pain during balloon inflation (depending on degree of sedation) at any step should suggest a previously unrecognized stricture.

If there is a suspicion of distal bile duct stricture during ERCP, especially in patients with a tapered distal bile duct, one can consider withdrawing a large-diameter inflated stone retrieval balloon through the suspected site to unmask its existence.

EPLBD Without Preceding Sphincterotomy (EST)

Recent studies have shown that EST followed by large-balloon dilation or large-balloon dilation only for the removal of large or difficult stones from the CBD has good efficacy and acceptable adverse event rates. Theoretically, EPLBD without EST is easier to manipulate than the combined method and is also more suitable for patients with concomitant large stones and bleeding tendency. Also, the main purpose of EPLBD for large bile duct stones is to preclude additional endoscopic procedures, such as endoscopic mechanical lithotripsy (EML), to simplify the process of stone extraction and reduce adverse events.

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