The ballooning time in endoscopic papillary large balloon dilation (EPLBD) remains controversial. The aim of this study was to evaluate the significance of the ballooning time comparing an immediate balloon deflation method with a conventional ballooning time of > 45 seconds.
Between January 2010 and December 2010, 126 patients with bile duct stones treated with EPLBD and endoscopic sphincterotomy were divided according to the ballooning time: the immediate deflation group (n=56) and the conventional inflation group (ballooning time 45s to < 60s) (n=70).
The overall success rate and the success rate of the first attempt of ERCP (endoscopic retrograde cholangio-pancreatography) were 96.4% (54/56) and 80.4% (45/56) in the immediate group and 97.1% (68/70) and 77.1% (54/70) in the conventional inflation group. There were no statistically significant differences in the overall success and the first attempt of ERCP success rate (
The ballooning time in EPLBD does not affect the outcomes of the treatment for bile duct stones. And the feasibility of the immediate deflation method in EPLBD is acceptable.
Endoscopic retrograde cholangiopancreatography (ERCP) has been widely accepted as a standard therapy for choledocholithiasis for decades. To facilitate stone removal, destruction or dilation of the bile duct orifice is necessary. Endoscopic sphincterotomy (EST) and endoscopic papillary balloon dilation (EPBD) are well established procedures in the treatment of bile duct stones. However, failure to extract the stones occurs in approximately 10-15% of patients [
In 2003, Ersoz et al.[
Between January 2010 and December 2010, 126 consecutive patients with difficult bile duct stones treated with EPLBD and a limited EST were enrolled in the study. The demographic and clinical data were retrospectively collected by reviewing medical records. In this study, difficult bile duct stone was defined as a stone greater than 12 mm in diameter (if multiple stones were present, the diameter of the largest one was documented) irrespective of the presence of periampullary diverticulum (PAD). All enrolled patients were ≥ 18 years of age and informed consent was obtained prior to ERCP. Exclusion criteria included: concomitant pancreatic or biliary malignant disorders, benign biliary stricture, combined with choledochoduodenal fistula, hepatolithiasis, clinically proven acute pancreatitis, and hemostatic disorders. Bile duct stones that were documented on initial imaging studies (ultrasonography, computed tomography or MRCP) but could not be identified during ERCP were excluded. Incomplete dilation, defined as when the waist of a balloon had not completely disappeared, even when the maximum pressure for the balloon was applied, was also excluded.
ERCP was performed using a side-viewing duodenoscope (TJF-240; Olympus Optical Co, Ltd, Tokyo, Japan). Two experienced endoscopists (Kim YS, Ku YS) who have performed more than 300 ERCP procedures annually for over 10 years performed all the ERCP procedures. Selective bile duct cannulation was achieved using the pull-type papillotome preloaded with a 0.035-inch guidewire or 0.035-inch cannula. Minimal pancreatography was employed only when a guidewire-assisted selective bile duct cannulation could not be obtained. Once the selective bile duct cannulation was achieved, an initial cholangiogram was obtained. Common bile duct (CBD) diameter, stone diameter (the largest one if multiple stones were present) the length of the distal CBD arm and CBD angulations were measured on the initial cholangiogram. A limited sphincterotomy, defined an incision limited to less than one-third of the length of the papillary roof, was performed and a balloon catheter (CRE Esophageal/Pyloric, maximum diameter 12, 15, 18, or 20 mm; length 5 cm, Boston Scientific, Natick, MA) was introduced and gradually inflated under endoscopic and fluoroscopic guidance; the dilation of the balloon catheter was chosen according to the diameters of the CBD and the stones. The ballooning time was left to endoscopist’s discretion. For the conventional inflation group, the balloon remained inflated for longer than 45 seconds but less than 60 seconds after the waist in the balloon had disappeared completely on fluoroscopic guided imaging. Ballooning time was defined as the period between the disappearance of waist of the balloon and deflation of the balloon. In the immediate deflation group, the balloon was deflated immediately after the waist of the balloon had disappeared and was not inflated again.
After balloon deflation, stone extraction was attempted using a retrieval balloon catheter to avoid impaction. If the stone extraction failed after 4 attempts with a retrieval balloon catheter, mechanical lithotripsy was attempted. Complete stone removal was documented using a final cholangiogram. If a residual stone was detected or suspected, a plastic stent (7Fr single- or double-pigtail) was inserted and a second ERCP was attempted within 3 or 4 days. Routine pancreatic stenting was not an intended part of the study protocol. Efficacy was evaluated by assessing the overall success rate for complete stone removal, the stone clearance rate of the first attempt of ERCP session and the frequency of mechanical lithotripsy. Safety was evaluated by assessing the incidence of major post-procedure complications (post- ERCP pancreatitis, bleeding and perforation). Complications were evaluated according to the consensus criteria published by Cotton et al.[
Continuous variables are expressed as the mean ± standard deviation (SD) or the median with a range when the variable did not show a normal distribution. Student’s
Of the 126 patients who enrolled in this study, 70 were assigned to the conventional inflation group and 56 were assigned to the immediate deflation group (
The overall success rate, the success rate of the first attempt of ERCP session, and the use of mechanical lithotripsy were evaluated to assess the efficacy of the procedures (
Major complications occurred in 4 patients (5.7%) in the conventional inflation group and 2 patients (3.6%) in the immediate deflation group (
Although EST has been widely accepted as the standard therapy for the treatment of bile duct stones for several decades, the treatment of difficult bile duct stones remains challenging. EPLBD creates a large orifice that facilitates the removal of large or multiple stones, and reduces the risk of stone impaction in the distal bile duct [
One area that remains controversial in EPLBD and EPBD is the ballooning time. In one EPBD study longer ballooning durations resulted in better outcomes and fewer complications [
Although similar results including overall success rates, stone clearance rate of first ERCP and the use of mechanical lithotripsy were noted in the two groups, the number of ERCP sessions for complete stone clearance was statistically higher in the conventional inflation group. However, it would be premature to conclude that the immediate deflation method is more effective than the conventional inflation method since the sample size in this study was small. Based on the results of this study, the overall efficacy of immediate balloon deflation in EPLBD for bile duct stone clearance was not inferior to the procedure using the conventional ballooning time.
The major complication rates did not differ between two groups (3.6% vs. 5.7%,
There are several limitations to our study. This study included a small number of cases and is retrospective in design. Also, the enrolled cases were heterogeneous and included those who had undergone a precut procedure for biliary access and patients who had undergone prior EST. Despite the limitations, the efficacy and safety of EPLBD with immediate balloon deflation were very favorable and balloon inflation during EPLBD does not affect the outcomes of the treatment for bile duct stones as suggested in a meta-analysis [
In conclusion, balloon inflation in EPLBD does not affect the outcomes of the treatment of bile duct stones. Moreover, the efficacy and safety of the immediate balloon deflation method in EPLBD were comparable with the conventional ballooning method. EPLBD with immediate balloon deflation can be considered for routine use. In the near future, a large, prospective study will be required to confirm the present findings.
The author has no conflicts to disclose.
Baseline characteristics in both groups
Immediate Group (n=56) | Conventional Group (n=70) | ||
---|---|---|---|
Age, yrs | 70.3 ± 10.2 |
70.8 ± 12.9 | 0.833 |
Gender | 0.748 | ||
Male | 24 (42.9) | 32 (45.7) | |
Female | 32 (57.1) | 38 (54.3) | |
Balloon size (mm) | 0.42 | ||
12 | 11 (19.6) | 11 (15.7) | |
15 | 27 (48.2) | 28 (40.0) | |
18 | 14 (25.0) | 20 (28.6) | |
20 | 4 (7.1) | 11 (15.7) | |
CBD stone (mm) Median with range | 14 (12-26) | 14 (12-32) | 0.42 |
CBD diameter (mm) | 19.8 ± 6.1 | 19.1 ± 6.0 | 0.512 |
PAD |
26 (46.4) | 41 (58.6) | 0.589 |
Length of the distal CBD arm (mm) | 35.2 ± 12.2 | 32.3 ± 9.3 | 0.151 |
CBD |
145.7 ± 17.5 | 144.7 ± 20.2 | 0.772 |
Precut | 3 (5.4) | 1 (1.4) | 0.322 |
Previous EST |
10 (17.9) | 18 (25.7) | 0.292 |
Past cholecystectomy | 15 (26.8) | 27 (38.6) | 0.393 |
Initial lab. Finding | |||
Total bilirubin (mg/dL) | 2.9 ± 2.4 | 3.4 ± 3.2 | 0.363 |
AST (U/L) | 194.2 ± 248.7 | 181.3 ± 247.3 | 0.773 |
ALT (U/L) | 187.1 ± 193.8 | 160.1 ± 184.5 | 0.438 |
sAP |
253.6 ± 218.9 | 198.6 ± 156.0 | 0.116 |
PAD: periampullary diverticulum.
sAP: serum alkaline phosphatase.
CBD: commo bile duct.
EST: endoscopic sphincterotomy.
Data are presented as mean±SD or number (%).
Comparison of efficacy between immediate deflation and conventional methods.
Immediate group (n=56) | Conventional group (n=70) | ||
---|---|---|---|
Overall success rate | 54 (96.4) |
68 (97.1) | 0.99 |
Success at first ERCP | 45 (80.4) | 54 (77.1) | 0.662 |
Number of ERCP sessions | 0.001 | ||
1 | 44 (78.6) | 32 (45.7) | |
2 | 12 (21.4) | 35 (50.0) | |
3 | 0 (0) | 3 (4.3) | |
Multiple sessions (≥2) | 12 (21.4) | 38 (54.3) | <0.001 |
Mechanical lithotripsy | 0 (0) | 5 (7.1) | 0.065 |
Data are presented as number (%).
Comparison of safety between immediate deflation and conventional groups.
Immediate group (n=56) | Conventional group (n=70) | ||
---|---|---|---|
EPLBD |
2 (3.6) |
4 (5.7) | 0.692 |
Post-ERCP pancreatitis | 1 (1.8) | 3 (4.3) | 0.628 |
Mild | 0 (0) | 2 (2.9) | |
Moderate | 1 (1.8) | 0 (0) | |
Severe | 0 (0) | 1 (1.4) |
|
Bleeding | 1 (1.8) | 0 (0) | 0.444 |
Perforation | 0 (0) | 1 (1.4) | 0.99 |
EPLBD: endoscopic papillary large balloon dilation.
Major complications include pancreatitis, bleeding and perforation.
The patient died from severe pancreatitis.
Data are presented as number (%).