Efficacy and safety of sphincterotomy with sphincteroplasty using large caliber balloons in the treatment of choledocholithiasis with extraction difficulties

doi:10.4236/ojgas.2013.34041

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Open Journal of Gastroenterology, 2013, 3, 241-248 OJGas

doi:10.4236/ojgas.2013.34041 Published Online August 2013 (http://www.scirp.org/journal/ojgas/)

Efficacy and safety of sphincterotomy with

sphincteroplasty using large caliber balloons

in the treatment of choledocholithiasis

with extraction difficulties

R. Uribarrena-Amezaga1, I. Aured De La Serna1, I. Calvo-Morillas1, J. J. Sebastián-Domingo2,

T. Cabrera-Chaves2, M. T. Soria San Teodoro1, R. Uribarrena-Echebarría1

1Department of Digestive Diseases, Miguel Servet University Hospital, Zaragoza, Spain

2Department of D i gestive Diseases, Royo Villanova Hospital, Zaragoza, Spain

Email: [email protected]

Received 9 June 2013; revised 11 July 2013; accepted 25 July 2013

License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Introduction: Endoscopic retrograde cholangiopan-

creatography (ERCP) with endoscopic sphincteroto-

my (ES) is the most widely used technique for treat-

ing choledocholithiasis. In some cases, due to anoma-

lies of the papilla or the presence of large or multiple

calculi, additional maneuvers are needed to remove

the stones. The present study investigates the efficacy

and safety of ES with sphincteroplasty (SP) in the

management of choledocholithiasis with extraction dif-

ficulties. Patients and Methods: A prospective study

was made of 153 patients with choledocholithiasis

subjected to ERCP. Fifty-two patients underwent ES

with SP, while 101 were subjected only to ES. The

two groups were compared in terms of age, gender,

percentage cannulation, presence of papilla altera-

tions, large or multiple stones, success in stone re-

moval and complications (acute pancreatitis, bleeding

and perforation). In the ES with SP group, we more-

over recorded the diameters of the balloons employed

(10 - 18 mm). Results: There were no significant dif-

ferences between the groups in the stone extraction

success rate (94.23% in the ES with SP group versus

97.03% in the ES group) or in the appearance of

complications (3.8% in the ES with SP group versus

2.7% in the ES group). The presence of difficult pa-

pillae, and of multiple or large stones was signifi-

cantly greater in the ES with SP group. The diameter

of the balloon was not associated with the appearance

of complications. Conclusion: Endoscopic sphinctero-

tomy with sphincteroplasty is effective and safe in the

treatment of choledocholithiasis with extraction dif-

ficulties.

Keywords: Choledocholithiasis; Endoscopic

Sphincterotomy; Sphincteroplasty

1. INTRODUCTION

Endoscopic retrograde cholangiopancreatography (ERCP)

with endoscopic sphincterotomy (ES) is the most widely

used technique for treating choledocholithiasis (CL) [1,2].

However, a number of factors may greatly complicate

the extraction of the stones. Large or multiple stones and

certain alterations of the papilla that impede extensive

ES are some of the circumstances that most often com-

plicate success of the procedure [3]. In the past, me-

chanical lithotripsy was more often used, and if this

technique failed, surgery was decided. In elderly patients

or individuals with a high surgical risk, the placement of

plastic biliary stents is an acceptable alternative [4].

However, the devices used for mechanical lithotripsy are

often complicated to assemble and handle. Furthermore,

the technique is not without complications [5]. The sur-

gical option is more aggressive and involves greater

morbidity and mortality than endoscopic treatment, par-

ticularly in very elderly individuals, which are the typical

type of patients that suffer CL. For these reasons, sphinc-

teroplasty (SP) with dilating balloons was introduced in

2003 as a routine method for expanding endoscopic

sphincterotomies that are found to be insufficient. It was

made of the same balloons designed for dilating stenotic

zones in other sections of the gastrointestinal tract, with

calibers ranging between 10 and 20 mm [6]. The present

study was carried out to evaluate the efficacy and safety

of the combination of ES with SP in our hands for the

treatment of choledocholithiasis with extraction difficul-

Published Online August 2013 in SciRes. http://www.scirp.org/journal/ojgas

R. Uribarrena-Amezaga et al. / Open Journal of Gastroenterology 3 (2013) 241-248

242

ties, and to determine whether the complications are

greater than when only ES is performed (Figure 1).

2. PATIENTS AND METHODS

2.1. Patients and Procedure

A prospective stud y was made of 153 patients d iagnosed

with choledocholithiasis in Miguel Servet University

Hospital (Zaragoza, Spain) during the period between

January 2009 and November 2011. All of the patients

were subjected to ERCP with ES. Fifty-two of them

moreover underwent SP after ES, and were compared

with the 101 patients of the con trol group, subj ected only

to ES. The indication of one technique or other depended

on the criterion of the endoscopist, after evaluating the

difficulty of stone removal. Written informed consent

was obtained from all patients at least 24 hours in ad-

vance. Antibiotic prophylaxis in the form of intravenous

amoxicillin-clavulanate was provided according to the

protocol used in our hospital, unless the patient had al-

ready been receiving bro ader spectrum antibiotics. In pa-

tients with allergy to betalactams, amoxicillin was re-

placed with ciprofloxacin plus metronidazole. The pro-

cedure was carried out under sedation with midazolam

and intravenous fentanyl, administered by the endo-

scopist, with the monitorization of oxygen saturation and

heart rate. Intravenous buscapine and atropine were also

administered. The canulation was performed with 0.025

Figure 1. Multiple and big bile duct stones.

and 0.035 inch guidewire double lumen sphincterotomes

(Olympus®). If direct canulation was not possible, we

used a needle knife (Olympus®) to make a precut. In

performing SP we used progressive 10 - 18 mm diameter

balloons, of the kind commonly used to dilate stenotic

zones in other sections of the gastrointestinal tract (Bos-

ton Scientific®). Dilatation diameter and pressure was

controlled by a manometer and maintained between 20

and 30 seconds for each caliber, and no more than three

different measures were used in each case. Removal of

the stones was carried out with a Fogarty balloon or

Dormia basket. In no case were pancreatic stents used.

The procedures were carried out by two endoscopists

experienced with the technique (Figures 2 and 3).

Data were collected related to the following:

Patients: age and gender.

Technique: need for precut, performance of SP after

Figure 2. Sphincterotomy and sphinteroplasty with large cali-

ber balloon.

Figure 3. Bile duct stones extracción after sphincterotomy plus

sphincteroplasty.

R. Uribarrena-Amezaga et al. / Open Journal of Gastroenterology 3 (2013) 241-248 243

ES, and caliber of the dilatatio n balloons.

Papilla: a difficult or risk papilla in relation to ES was

defined by the presence of dissimilarity between the size

of the papilla and the diameter of the stones, intradiver-

ticular papi l l ae, and pat i e nt s wi t h p revious ES.

Stones: multiple (more than 2) or large (>10 mm in

diameter).

Complications: acute pancreatitis, perforation, signifi-

cant digestive b leeding, cholangitis or acu te cholecystitis

and death. Acute pancreatitis and its severity were de-

fined following the criteria of Cotton [7,8].

We only registered significant bleeding requiring trans-

fusion or endoscopic or surg ical hemostatic maneuvering

after the procedure. Mild or self-limited bleeding requir-

ing no special measures and implying no prolongation of

hospital stay were not considered.

Success was taken to represent complete removal of

the stones, while failure was considered when otherwise.

In the event of failure, we resorted to biliary stent place-

ment consumables or surge ry.

2.2. Statistical Analysis

2.2.1. Descriptive Anal y si s

In the descriptive analysis qualitative variables were ex-

pressed as percentages. In the case of quantitative vari-

ables, we first evalu ated normal distributio n with the Kol-

mogorov-Smirnov and Shapiro-Wilks tests. Those quan-

titative variables exhibiting a normal distribution were

reported as the mean and standard deviation, while vari-

ables with a non-normal distribution were reported as the

mean, median and interquartile range.

2.2.2. Inferential Analysis

The following statistical tests were used for the simple or

bivariate analyses:

 Pearson chi-squared test: This test was used for the

comparison of two categorical variables. As criterion

for using this test, all the expected values in the con-

tingency table were required be greater than 5.

 Fisher exact test: This test was used for the compari-

son of two dichotomic categorical variables when all

the expected values in the contingency table were

over 1 and one or more were under 5.

 Linear association test: This test was used for the

comparison of categorical variables in which one va-

riable was of an ordinal qualitative nature with more

than two categories.

 Student t-test: This test was used for the comparison

of two means corresponding to a quan titative variable

versus a dichotomic variable. As criterion for apply-

ing the Student t-test, the quantitative variable was

required to present a normal distribution for each of

the sample subgroups defined by the values which the

dichotomic variable may present.

 Mann-Whitney U-test: This nonparametric test was

used for the comparison of two means when the crite-

ria required for applying the Student t-test were not

met.

Assessment of the magnitude of the association was

based on calculation of the hazard ratio or relative risk

(RR), while the precision of the estimation of effect was

measured using the 95% confidence interval (CI) of the

RR.

Statistical significance was considered for p < 0.05.

3. RESULTS

A total of 153 patients (77 males and 66 females) be-

tween 18 and 97 years of age (mean 74.23 years, stan-

dard deviation (SD) 13.8) were included in the study.

The mean age of the ES with SP group (75.25 years, SD

12.55) was similar to that of the ES group (73.71 years,

SD 14.44). As reg ards the gender d istribution, males and

females respectively represented 42.31% and 57.69% in

the ES with SP group, and 54.46% and 45.5 4% in the ES

group.

Bile duct cannulation was achieved in all patients: di-

rectly in 150 cases (98.08 % in the ES with SP group and

98.02% in the ES group) and using precut in three cases

(1 in the ES with SP group and 2 in the ES group).

We used balloons with calibers between 10 and 18 mm,

depending on the characteristics of the papilla, the size

and number of stones, and the bile duct diameter. The

mean balloon diameter was 12.80 mm (SD 2.28) (De-

scriptive quantitative and qualitative variable are sum-

marized in Tables 1 and 2).

The procedure proved successful in 49 of the 52 pa-

tients in the ES with SP group (94.23%) and in 98 of the

101 patients of the ES group (97.03%). The difference

between the two groups was not statistically significant

(p = 0.409) (Ta ble 3). In the 6 patients in which stone

removal was not possible, we placed between one and

three plastic stents (caliber 10 Fr) in 5 cases. One patient

in the ES w ith SP group required emergency surgery due

to perforation with retro-pneumoperitoneum and stone

impaction in the distal choledochus.

The presence of a difficult or risk papilla for ES was

significantly more frequent in the ES with SP group

(76.92%) than in the ES group (36.63%) (p = 0.000).

Likewise, stones measuring over 1 cm in size were more

common in the ES with SP group than in the ES group

(50% versus 26.73%, respectively; p 0.001), in the same

way as the presence of multiple stones (38.46% versus

14.84%; p 0.0 0 7) .

The global percentage of relevant complications was

3.28% (5 out of 153 cases). The most frequent problem

was acute pancreatitis (3 cases, 1.98%). In no case was

the latter serious, however. There were no deaths related

to the technique.

Analyzed by groups, the patients subjected to ES with

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244

OJGas

Table 1. Descriptive study. Qualitative variables in ES + SP and ES groups.

Case or control

Case (ES + SP group) Control (ES group)

N % N %

Male 22 42.31% 55 54.46%

Gender Female 30 57.69% 46 45.54%

Yes 40 76.92% 37 36.63%

Difficult papilla No 12 23.08% 64 63.37%

Yes 14 26.92% 29 28.71%

Diverticulum No 38 73.08% 72 71.29%

Yes 10 19.23% 2 1.98%

Small size No 42 80.77% 99 98.02%

Yes 17 32.69% 5 4.95%

Previous EE No 35 67.31% 96 95.05%

Yes 26 50.00% 27 26.73%

Large st o ne No 26 50.00% 74 73.27%

Yes 20 38.46% 15 14.85%

Multiple stones No 32 61.54% 86 85.15%

Yes 1 1.92% 0 0.00%

Perforation No 51 98.08% 101 100.00%

Yes 0 0.00% 1 0.99%

Bleeding No 52 100.00% 100 99.01%

Yes 1 1.92% 2 1.98%

Pancreatitis No 51 98.08% 99 98.02%

Yes 0 0.00% 0 0.00%

Death No 52 100.00% 101 100.00%

Direct cannulation 51 98.08% 99 98.02%

Type of access Precut 1 1.92% 2 1.98%

Yes 49 94.23% 98 97.03%

Extraction of stones No 3 5.77% 3 2.97%

Table 2. Descriptive study. Quantitative variables in ES + SP and ES groups.

Total Cases (ES + SP) Controls (ES)

Mean SD Mean SD Mean SD

Age 74.23 13.80 75.25 12.55 73.71 14.44

Balloon diamete r 12.80 2.28 12.80 2.28

SP suffered two major complications (3.8%): pan creatitis

in one case (1.9%) and perforation at papillary leve l dur-

ing extraction maneuvering in another case (1.9%). In

the ES group we recorded three complications (2.7%):

two cases of acute post-ERCP pancreatitis (2%) and one

significant bleeding episode that was resolved by endo-

scopic sclerosis with adrenalin and ethoxysclerol, and

which required red cell concentrate transfusion (0.7%).

All complications were controlled with medical and en-

doscopic treatment, except the perforation with stone

impaction in the distal choledochus, which required

emergency surgery. Globally, the number of complica-

tions was very low and similar in both groups, with no

statistically significan t differences between them (p 0.65)

(Table 4). On grouping by type of complication, only

acute pancreatitis reached a sufficient number to allow

comparisons to be made. The Fisher exact test yielded p

= 1, i.e., in this case there likewise were no significant

differences between the two patient groups (Table 5).

There were no deaths attributable to either technique

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Table 3. Inferential analysis. Comparison of success of stone removal in ES + SP and ES groups. There are no significant differences

between the 2 groups (p = 0.409).

Satisfactory result

Yes No Total

N 49 3 52

Case ES + SP % 94.2% 5.8% 100.0%

N 98 3 101

Case or control

Control ES % 97.0% 3.0% 100.0%

N 147 6 153

Total % 96.1% 3.9% 100.0%

Inferential analysis . Fisher tes t ; p = 0.409; Nonsignificant (p > 0.05 ) .

Tabe 4. Inferential analysis. Comparison of global complications (pancreatitis, bleeding and perforation) in ES + SP and ES groups.

There are no significant differences between the 2 groups (p = 0.65).

Global complications

Yes No Total

N 2 50 52

Case ES+SP % 3.8% 96.2% 100.0%

N 3 98 101

Case or control

Control ES % 2.7% 97.3% 100.0%

N 5 148 153

Total % 3.28% 96.72% 100.0%

Tab le 5. Inferential analysis. Comparison of post-ERCP pancreatitis in ES + SP and ES groups. There are no significant differences

between the 2 groups (p = 1.000).

Pancreatitis

Yes No Total

N 1 51 52

Case ES+SP % 1.9% 98.1% 100.0%

N 2 99 101

Case or control

Control ES % 2.0% 98.0% 100.0%

N 3 150 153

Total % 2.0% 98.0% 100.0%

Inferential analysis . Fisher tes t ; p = 1.000; Nonsignificant (p > 0.05 ) .

(ES with SP or ES alone).

Analysis of the possible influence of patient age or

dilatation balloon diameter upon the appearance of com-

plications showed no relationship between these vari-

ables and morbidity associated with the technique.

4. DISCUSSION

In most cases, biliary duct stones can be removed by

ERCP with ES, using a Dormia basket of Fogarty bal-

loons [9]. Howev er, in the presence of large or numerous

stones, or when the papilla does not allow extensive ES,

the usual technique is proved to be unable to extract the

stones in up to 15% of the cases [3,4,10]. Under these

circumstances, we may use mechanical lithotripsy (in-

volving shock waves, laser or electrohydraulics) or to opt

for surgery [10]. Mechanical lithotripsy devices are not

always easy to handle, and tend to significantly prolong

the procedure. In addition, they are less effective in ap-

plication to large or impacted stones, and have a rela-

tively high complication rate [5,9,10]. More sophisti-

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246

cated intraductal lithotripsy techniques such as electro-

hydraulic or laser lithotripsy, etc., for the fragmentation

of large stones, are expensive and available in very few

centers [11-14]. The placement of plastic biliary stents

may offer a temporary solution prior to surgical removal,

or may represent a definitive treatment option in very

elderly patients or individuals with a very high surgical

risk [14,15]. When we use this technique and have al-

ready performed ES, we usually place more than one

plastic stent in order to ensure improved drainage, and

also to avoid displacements.

ES with SP is a very good alternative that minimizes

the need for lithotripsy and surgery. The technique en-

larges the diameter of the papilla and distal choledochus

quickly and easily, and allows us to remove stones in-

volving greater extraction difficulties. We maintain dila-

tation for approximately 30 seconds with each balloon

caliber, and do not use more than three different diame-

ters. With progressive balloons, the procedu re can be car-

ried out using a single balloon. The minimum diameter

used in our experience was 10 mm, with a maximum of

18 mm. We found no relationship between the size of the

balloon and the appearance of complications. There is no

consensus in the literature on the extent of previous ES,

dilatation time, or maximum balloon size. Shim et al.

recommend a small ES in order to lessen the risk of per-

foration [14], while in contrast Attam and Mayedeo rec-

ommend that ES should be as extensive as possible

[11,16]. We are more in agreement with this latter posi-

tion, and do not modify the extent of ES according to

whether dilatation will be carried out or not. Moreover,

in many cases the decision to dilate is made after con-

firming that the stones cannot be removed with ES alone.

Martín-Arranz maintains insufflation during one min-

ute [9], while other authors limit this time to between 15

- 30 seconds [13,17]. Most studies, including our own,

use balloon diameter s of between 10 and 20 mm [6,9,11,

13,17-20], and in abidance with our own practice, it is

generally advised not to exceed the diameter of the bil-

iary tract [11]. We indistinctly use Fogarty balloons or

Dormia baskets, and sometimes combine both devices.

The risk of trapping within th e papilla is greater with the

basket, but traction force is greater. With the Fogarty

balloon, trapping does not occur, but in some cases this

device proves less effective.

In contrast to Itoi et al. [13], in our study the incidence

of choledocholithiasis with extraction difficulties (multi-

ple stones, large stones, peri-ampullar diverticulum or

previous ES) was significantly greater in the ES with SP

group than in the patients only subjected to ES. This is

logical, considering that patient assignment to one group

or others was not randomized. The addition of SP to ES

was decided by the endoscopist, in tho se cases where re-

moval of the stone or stones was expected to be difficult

with the conventional methods, or when extraction with

simple ES proved unsuccessful. This way of assigning

patients to one group or others distinguishes our series

from most published studies, in which distribution is

made on a random basis. In this context, our study is

more consisten t with routine clin ical practice, where treat-

ment decisions are not taken randomly but depend on the

circumstances of each individual case.

Although a priori removal of the stones proved more

difficult in the ES with SP group, the success rate was

similar in both cases (94% in the ES with SP group ver-

sus 97% in the ES group) and consistent with the find-

ings of other studies [13,14,16,17,19,21,22]. Likewise,

no differences were observed between the two groups in

terms of complications.

In the reviewed literature, the most common compli-

cation of ERCP with ES is acute pancreatitis (observed

in 5% of all cases), followed by significant digestive

bleeding (2%), cholangitis (1%) and perforation (0.3%),

the mean mortality rate being 0.4% [23,24]. A larger

number of complications would be expected on adding

SP to ES, which has its own iatrogenic effects. This is all

the more so when considering the greater complexity of

those cases in which both procedures are combined. In

our series, the global mortality rate was 3.28%, and was

only slightly high er in the ES with SP group (3.8%) than

in the ES group (2.7%)—with no significant differences

between them. Our complication rate was somewhat

lower than in other studies [13,14,16,17,22]. The inci-

dence of acute pancreatitis was practically identical in

both groups (1.9% in the ES with SP group versus 2% in

the ES group), and in no case did we use pancreatic

stents. This appears to confirm the findings in the litera-

ture to the effect that dilatation after ES results in far

lower pancreatitis rates than when only performing SP

[13,17,25,26]. Probably, the inflammatory reaction caused

by SP, which can affect drainage of the pancreatic duct,

is mitigated by the effect of previous ES, which separates

the pancreatic and biliary orifices. Accordingly, to date

SP without prior ES is reserved for situations in which

ES is contraindicated, such as patients with coagulation

disorders or receiving treatment with anticoagulants or

antiplatelet drugs, etc. [25,26]. However, a recently pub-

lished metaanalysis has concluded that SP involving

longer dilatation (up to 5 minutes) and using larger di-

ameter balloons is more effective, with effects similar to

those of ES and involving similar pancreatitis and lower

overall complication rates [27].

Our only case of perforation occurred in a patient with

stenosis of the distal choledochus, and we considered

that this complication was more a consequence of ma-

neuvering during stone removal than a result of dilatation

as such. Perforation was diagnosed from the identifica-

tion of a retro-pneumoperitoneum on the abdominal X-

R. Uribarrena-Amezaga et al. / Open Journal of Gastroenterology 3 (2013) 241-248 247

rays. The isolated presence of a retro-pneumoperitoneum

not associated with pneumoperitoneum usually implies a

small perforation that normally can be managed with

absolute diet, fluid therap y and antibiotics [28]. However,

in our case the stone was impacted due to the lesser cali-

ber of the distal choledochus and despite SP, as a result

of which the decision was made to deal with both prob-

lems surgically.

In conclusion, endoscopic sphincterotomy with sphin-

cteroplasty is a simple, safe and effective procedure for

the management of choledocholithiasis with extraction

difficulties, and reduces the need for other more aggres-

sive, complex or expensive techniques.

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ABBREVIATIONS

ERCP: endoscopic retrograde cholangiopancreatography

ES: endoscopic sphincterotomy

SP: sphincteroplasty

RR: relative risk

CI: confidence interval

SD: standard deviation