Background
A common bile duct (CBD) stone complicated with cholangitis, obstructive jaundice, or pancreatitis is a common disease of the biliary tract. Gaining access to the CBD is the most importance step for successful therapeutic endoscopic retrograde cholangiopancreatography (ERCP) [
1‐
7]. The cannulation success rate depends on patient selection, the utilization of a specialized catheter, and the skill and experience of the endoscopist [
2,
7]. The overall success rate of cannulation has been reported to be 90–95 % even when performed by experts [
1‐
5]. However, in 5–10 % of cases, the CBD remains inaccessible, necessitating precut sphincterotomy (PS) or fistulotomy (PF), percutaneous transhepatic biliary drainage (PTBD), endoscopic ultrasound (EUS)-guided drainage, or surgery [
1‐
7]. Difficult biliary cannulation is defined as a situation in which an endoscopist, using the regular cannulation technique, fails to cannulate the bile duct within a certain amount of time or after a certain number of attempts [
3,
6]. Some investigators have proposed the definition of difficult biliary cannulation as (1) failed cannulation within 10 min, (2) >5 pancreatic cannulation attempts, or (3) 5–10 attempts at the papilla without a time limit [
1‐
7]. Difficult biliary cannulation leads to prolonged papillary manipulation resulting in not only tissue edema but also repeated attempts at cannulation or contrast injection of the pancreatic duct, and these factors have been reported to cause post-ERCP pancreatitis in 4.3–11.3 % of cases [
1,
3,
5,
6]. Needle-knife PS is the most commonly used procedures in patients with difficult biliary cannulation, and it has been reported to have success rates of 74.5–98.2 % [
1‐
4,
6,
7]. However, PS is associated with post-ERCP complications such as acute pancreatitis, duodenal bleeding and perforation, and is often regarded as a risky procedure, with complication rates of 2–34 % [
1‐
7]. Some published studies have reported that sequential endoscopic papillary balloon dilation (EPBD) after endoscopic sphincterotomy (EST) is safe and effective for the management of CBD stones and could decrease the occurrence of complications, including procedure-related pancreatitis [
8‐
13]. However, reports on the efficacy of limited PS combined with EPBD for CBD stone removal in patients with of difficult biliary cannulation are scarce.
Therefore, the present study aimed to report the efficacy and safety of limited PS combined with EPBD for CBD stone removal in patients with difficult biliary cannulation, and the complications associated with this combined procedure.
Results
This study included 58 patients (28 men and 30 women) with CBD stones who underwent limited PS combined with EPBD. The mean age of the patients was 64.02 years (range, 26–96 years). The characteristics of the patients are presented in Table
1. The procedure findings during limited PS combined with EPBD are presented in Table
2. Complete removal of CBD stones was achieved in 55 patients (94.8 %). Of these 55 patients, 51 patients (87.9 %) required 1 session and 4 patients required 2 sessions for complete removal (Table
2). The mean size of the CBD stones was 1.11 ± 0.40 cm (range, 0.4–2.0 cm) and the mean diameter of CBD was 1.47 ± 0.44 cm (range, 0.7–2.6 cm). Of the 58 patients, 28 patients had one stone, 14 patients had 2 stones, and 16 patients had ≥3 stones. Additionally, among the 58 patients, 41 patients had distal CBD narrowing, 41 patients had jaundice, 28 patients had biliary tract infection (BTI), 19 patients had duodenal periampullary diverticulum, and 13 patients had impacted CBD stones. Removal was successful in 100 % (19/19) of patients with stones ≤1 cm and 92.3 % (36/39) of patients with stones >1 cm (
p = 0.544, Fisher’s exact test). EML was used to crush stones >15 mm in diameter when extraction of these stones was difficult after EPBD in 6 patients (10.3 %). Removal failed in 3 patients because of large stones (1.5–2.0 cm) and CBD segmental strictures, and all the 3 patients underwent surgery for removal of the CBD stones. Among the 58 patients, 2 patients (3.4 %) had procedure-related duodenal bleeding and were successfully treated with endoscopic epinephrine injection. None of the patients with CAD, heart disease or stroke requiring anticoagulant treatment; cirrhosis; or end-stage renal disease (ESRD) had procedure-related duodenal bleeding or perforation. Among the 58 patients, 5 patients (8.6 %) had procedure-related acute pancreatitis (mild pancreatitis). Of the 5 patients, 2 were men (7.1 % of the 28 men) and 3 were women (10 % of the 30 women), and 2 of the 5 patients were under 60 years of age. One patient (1.7 %) had procedure-related BTI, and the pathogen was
Escherichia coli. The overall complication rate was 13.7 % (8/58). The mean follow-up period was 29.0 ± 14.9 months (range, 1–60 months), and no recurrence of symptomatic CBD stones was noted during the follow-up period. The mean procedure time of limited PS combined with EPBD was 41.0 ± 11.5 min (range, 20–72 min).
Table 1
The characteristics of 58 patients underwent limited PS combined with EPBD
Gender (M:F) | 28:30 |
Mean age (range) yr | 64.02 ± 16.37 (26–96) |
Age (<60 : ≥60 : ≥70) yr | 18:40:23 |
Gallstone | 31 |
Prior cholecystectomy | 14 |
Acute pancreatitis | 8 |
Jaundice | 41 |
Biliary tract infection | 28 |
Liver cirrhosis | 7 |
Hypertension | 22 |
Diabetes mellitus | 11 |
ESRD | 4 |
CAD and heart disease | 8 |
Hyperlipidemia | 15 |
Malignancy | 6 |
Stroke | 3 |
COPD and asthma | 4 |
Table 2
Procedure findings during limited PS combined with EPBD
Complete bile duct stone clearance | 55 |
Number of sessions required to complete bile duct stone clearance (1:2) | 51:4 |
Successful removal of CBD stone (≤1 cm : >1 cm) | 19:36 |
Mean stone size (range) | 1.11 ± 0.40 (0.4–2.0) cm |
Stones size (≤1 cm : >1 cm) | 19:39 |
Stone number (1:2: ≥3) | 28:14:16 |
Mean CBD diameter (range) | 1.47 ± 0.44 (0.7–2.6) cm |
CBD diameter (≤0.8 cm : >0.8 cm) | 4:54 |
Periampullary diverticulum | 19 |
Distal CBD narrowing | 41 |
Impacted CBD stone | 13 |
Mechanical lithotripsy | 6 |
Procedure time | 41 ± 11.48 (20–72) min |
Discussion
Current study achieved a high success rate in CBD stones removal of 94.8 % with a relative shorter mean procedure time needed was 41.0 ± 11.5 min (range, 20–72 min) in patients who underwent limited PS combined with EPBD. Difficult biliary cannulation is one major reason that influences the success rates and procedural times used to remove bile duct stones during ERCP. It is usually decided depending on the length of time, number of selective biliary cannulation attempts, or the number of unwanted pancreatic cannulations, or insertion of a guide-wire into the pancreatic duct [
2]. In approximately 5–10 % of patients, biliary cannulation cannot be achieved, and further complex techniques are needed. Prolonged and repeated attempts of biliary cannulation (more than 1 cannulation attempt or the cannulation time was greater than 10 min) resulted in extensive injury to the papilla and lead to post-ERCP pancreatitis [
16,
17].
The causes of difficult biliary cannulation are related to anatomical and physiological factors, such as a floppy papilla, small papillary orifice, cervical of the papilla, periampullary diverticulum, and surgically altered anatomy, and improper positioning of the duodenoscope [
3,
4,
18]. Additionally, pathological conditions, such as stenosis of Oddi’s sphincter, duodenal inflammation, ampullary and papillary neoplasms, large size or number of stones, impacted stones, bile duct strictures, and a relatively narrow distal CBD compared with the stone size can cause difficult biliary cannulation [
3,
4,
19]. Distal CBD narrowing (41/58) was the major cause of difficult biliary cannulation in our study, and it may be related to chronic cholangitis. A duodenal periampullary diverticulum (19/58) and impacted CBD stone (13/58) were also common causes of difficult biliary cannulation in our study.
The solutions for overcoming difficult biliary cannulation in order to increase the success rate in CBD stones removal and shortening the procedure time include changing the catheter or operator, or applying a more aggressive method, keeping in mind the increased risk of complications [
6]. The more aggressive methods include needle-knife PS, papillary roof excision, transpancreatic sphincterotomy, transpancreatic stenting, the double wire technique, persistence, papillectomy, and the use of a special knife [
6]. If endoscopic methods fail, the transhepatic route can be used directly without an endoscopist or the rendezvous technique can be applied, depending on the cause of difficult biliary cannulation [
6]. Needle-knife PS is the most commonly used technique for difficult biliary cannulation, and it has a success rate of 74.5–98.2 % and complication rate has been reported to be 2–34 % such as bleeding (2–9.5 %), pancreatitis (0.5–7.6 %) and perforation (1.4–3 %) [
1‐
4,
6,
7,
18,
20]. Some studies have recommended the used of needle-knife PS in the following situations: (1) stone impacting the papillary orifice, (2) significant eminence of the ampulla or dilation at the end of the CBD, (3) acute obstructive suppurative cholangitis and pancreatitis due to biliary disorder, and (4) Billroth II gastrectomy [
7]. However, needle-knife PS is contraindicated for a small flat papilla, periampullary diverticulum and malignant change of the papilla, because the procedure can potentially make the cannulation approach difficult or unsafe to perform [
7]. The early application of needle-knife PS for difficult biliary cannulation has been reported to be time-saving, safe, and effective, with no increase in the complication rate [
1,
2,
4,
7]. Limited endoscopic sphincterotomy (EST) could minimize the risk of complications that occur after complete EST such as bleeding, bile reflux and biliary tract malignancy [
8]. Among the 55 patients with successful CBD stone removal, the success rate for single-session removal was 87.9 % (51/58) while the other four needed more than once subsequent session removal of stones but were all removed eventually(94.8 % overall). The therapeutic outcome in the present study was as good as that reported previously for patients without difficult biliary cannulation who underwent EST or EPBD (79–100 %), or combination therapy (80–100 %) with an acceptable complication rate (13.7 %) [
9‐
13,
18‐
25] with only mild procedure related pancreatitis (8.6 %) and bleeding (3.4 %).
In the present study, no difference was noted in the removal rate between CBD stones ≤1 cm (100 %, 19/19) and those >1 cm (92.3 %, 36/39) (
p = 0.554, Fisher’s exact test). The proportion of patients who need EML to crush stones when extraction of these stones was difficult after EPBD was 10.3 % in the present study. This did not differ from the proportion of patients without difficult biliary cannulation who underwent EST and EPBD combination therapy and needed EML in previous studies (0–33 %) [
8‐
12,
23]. The procedure time for CBD stone removal was longer in the present study (mean, 41.0 ± 11.5 min; range, 20–72 min) than in previous studies that reported patients without difficult biliary cannulation (EST: mean, 21.9 ± 14.7 min; range, 3–63 min and EST combined with EPBD: mean, 13.1 ± 6.6 min; range, 4–35 min) [
12]. The reason for the longer procedure time in the present study might be the extra time required owing to difficult biliary cannulation. There was no definite recurrence of symptomatic CBD stones during the follow-up period (mean, 29.0 ± 14.9 months; range, 1–60 months) in our study.
The present study had some limitations. First, this was a non-randomized retrospective study. Second, the sample size was small for statistical analysis such as univariate and multivariate analysis to evaluate clinical factors associated to the outcome. A larger sample size is needed to further confirm the results of the present study.
Abbreviations
CBD, common bile duct; CT, computer tomography; EML, endoscopic mechanical lithotripsy; EPBD, endoscopic papillary balloon dilation; ERBD, endoscopic papillary balloon dilation; ERCP, endoscopic retrograde cholangiopancreatography; ESRD, end-stage renal disease; EST, endoscopic sphincterotomy; EUS, endoscopic ultrasound; PF, precut fistulotomy; PS, precut sphincterotomy; PTBD, percutaneous transhepatic biliary drainage
Acknowledgements
The authors wish to thank Ms. Ching-Yi Lin for her assistance during the preparation of the manuscript.