Introduction
Up until approximately the last decade, Billroth II gastectomy was the most common
surgically altered anatomy that resulted in challenging endoscopic retrograde cholangiopancreatography
(ERCP) procedures. ERCP in such patients is usually performed with a duodenoscope
or a standard forward-viewing endoscope. Endoscopic and ERCP challenges in patients
with Billroth II gastrectomy include identification of and access to the afferent
limb, maneuvering through the often long afferent limb to reach the papilla, cannulation
of the native papilla (with or without an elevator), and performing a biliary endoscopic
sphincterotomy (BES) in a reversed direction. As a result, the ERCP success rate is
lower and the complication rate is higher in such patients than it is in those with
a normal gastrointestinal (GI) anatomy. In the literature, the success rate of ERCP
in patients with a prior history of Billroth II gastrectomy varies from 68 % to 92 %
[1]
[2]
[3]
[4]
[5]
[6]. More importantly, the overall perforation rate reaches 18 %, and procedure-related
mortality reaches 3.4 % [1]
[2]
[3]
[4]
[5]
[6].
Double-balloon enteroscopy (DBE) was first introduced in 2001 as a novel endoscopic
technique that allows examination of the entire small bowel [7]. Diagnostic and therapeutic ERCP procedures in which DBE is used have been successfully
applied in patients with surgically altered pancreaticobiliary anatomy (e. g., Billroth
II gastrectomy and Roux-en-Y anastomosis) since 2006 [8]
[9]
[10]
[11]
[12]. Most published series of overtube-assisted enteroscopy ERCP included both patients
with Billroth II gastrectomy and patients with Roux-en-Y anastomosis, but the endoscopic
outcomes and underlying pathologies differed between these two entities [13]. A large series of DBE-assisted ERCP focusing on patients with Billroth II gastrectomy
was therefore needed.
Bile duct stones are routinely removed at the time of ERCP after BES with a standard
balloon or basket extraction technique. However, bile duct stones in patients with
Billroth II gastrectomy are difficult to remove because of the challenging access
to the bile duct and the inverted direction in which BES must be performed. Traditional
techniques for enlarging the biliary orifice to facilitate the removal of such stones
require (1) the use of a reversed-angle biliary sphincterotome or (2) the placement
of a biliary stent followed by needle-knife sphincterotomy over the stent and supplemental
endoscopic papillary balloon dilation (EPBD) of the biliary orifice when large stones
are encountered [14].
The efficacy and safety of endoscopic papillary large-balloon dilation (EPLBD; ≥ 10 – to
12-mm balloon) without preceding BES for the removal of common bile duct stones in
normal GI anatomy have been reported in several retrospective studies [15]
[16]
[17]
[18]. One small prospective randomized controlled study demonstrated comparable rates
of successful stone clearance and complications between EPLBD and BES in patients
with normal GI anatomy [19]. A subsequent meta-analysis confirmed that the efficacy and safety of EPLBD alone
and BES plus EPLBD for the removal of bile duct stones were similar [20]. The feasibility, efficacy, and safety of EPLBD alone for the removal of bile duct
stones by DBE-assisted ERCP in patients with Billroth II gastrectomy have not been
reported.
The primary objective of our study was to evaluate the success of DBE-assisted ERCP
in patients with Billroth II gastrectomy. The secondary objective was to examine the
efficacy and safety of EPLBD alone for the removal of difficult bile duct stones in
Billroth II anatomy.
Patients and methods
We reviewed the endoscopic database at Chang Gung Memorial Hospital from April 2006,
when DBE (EN-450 T5 /W, EC-450 BI5; Fujifilm Endoscopy, Omiya, Japan) was first launched
at the institution, to the end of the study period in December of 2013 for patients
with Billroth II gastrectomy undergoing enteroscopy with the intent of performing
ERCP. The long DBE (EN-450 T5 /W) was applied until June 2007, when the short DBE
(EC-450 BI5) became available in our institution. The study was approved by the institutional
review board of Chang Gung Memorial Hospital. Patients underwent DBE-assisted ERCP
after a traditional side-viewing duodenoscope (JF-260; Olympus Optical, Tokyo, Japan)
and a forward-viewing upper endoscope (GIF-Q260; Olympus Optical) had failed to enter
the afferent limb or reach the major papilla. Reports of six patients who participated
in this study were previously published [9]. The database information included patient demographics, symptoms, procedure indications,
surgical anatomy, results of noninvasive imaging, prior ERCP attempts, type of sedation,
ERCP accessories used, intended duct opacification, endoscopic and radiographic findings,
interventions, completion of the intended intervention, reasons for failure, diagnoses,
complications, and follow-up, which included subsequent DBE-assisted ERCP, percutaneous
trans-hepatic cholangiography, surgery, and assessment of clinical response. The DBE
used in the study has a 2.8-mm working channel, which limits the size of devices that
can be used to less than 8.5 Fr. Characteristics of the long and short DBE devices
and the compatible ERCP accessories used in this study are listed in [Table 1].
Table 1
Double-balloon enteroscope characteristics and compatible ERCP devices used in a study
of papillary large-balloon dilation in patients with Billroth II anatomy.
|
Long DBE (EN-450 T5 /W, Fujifilm Endoscopy)
|
Short DBE (EC-450 BI5, Fujifilm Endoscopy)
|
|
Diameter of scope, mm
|
9.4
|
9.4
|
|
Working length, cm
|
200
|
152
|
|
Working channel, mm
|
2.8
|
2.8
|
|
Overtube diameter, mm
|
13.2
|
13.2
|
|
Overtube length, cm
|
145
|
105
|
|
Cannula
|
Glo-Tip catheter, 320 cm (Cook)
|
Glo-Tip catheter, 200 cm (Cook)
|
|
Guidewire
|
Axcess 21 wire, AX-21 – 650E, 650 cm (Cook)
|
Jagwire, 450 cm (Boston Scientific)
|
|
EPBD balloon
|
CRE balloon, multiple sizes (Boston Scientific)
|
CRE balloon, multiple sizes (Boston Scientific)
|
|
Sphincterotome
|
NA
|
Autotome (Boston Scientific)
|
|
Extraction balloon
|
ESCORT II balloon, EBL-18 – 320E, 320 cm (Cook)
|
Extractor Pro Rx Retrieval Balloon (Boston Scientific)
|
|
Retrieval basket
|
NA
|
Dormia basket (Olympus)
|
|
Mechanical lithotriptor
|
NA
|
BML-4Q-1 (Olympus)
|
|
Biliary plastic stent
|
Geenen stent, 7 Fr (Cook)
|
Geenen stent, 7 Fr (Cook)
|
|
Biliary metal stent
|
NA
|
Wallstent (Boston Scientific)
|
|
Pancreatic stent
|
Geenen stent, 7 Fr (Cook)
|
Geenen stent, 7 Fr (Cook)
|
|
Biopsy forceps
|
FTE-Biopsy forceps, 250 cm (Fujifilm Endoscopy)
|
FTE-Biopsy forceps, 250 cm (Fujifilm Endoscopy)
|
DBE, double-balloon enteroscope; EPBD, endoscopic papillary balloon dilation.
Endoscopic papillary large-balloon dilation procedures
After successful selective biliary cannulation, cholangiography was performed to confirm
the existence of common bile duct stones. After a guidewire had been inserted into
the bile duct, a dilation balloon (CRE balloon, 55 mm in length, 8 – 10 mm/10 – 12 mm/12 – 15 mm/15 – 20 mm
in diameter; Boston Scientific, Natick, Massachusetts, USA) was positioned across
the major papilla with the mid-portion of the balloon placed at the biliary orifice.
Under fluoroscopic guidance, the EPBD balloon diameter was selected according to the
size of the stones and bile duct proximal to the tapered segment. Under fluoroscopic
and endoscopic guidance, the balloon was gradually inflated with dilute contrast medium
until the waist of the balloon had disappeared. Thereafter, the pressure for inflating
the balloon was gradually increased until the desired diameter was achieved. Then
the pressure was maintained for 3 to 5 minutes based on a previous study [16]. After removal of the balloon, bile duct stones were extracted with a retrieval
balloon or basket. A mechanical lithotriptor (BML-4Q-1, Olympus) was used to fragment
the stones when standard methods failed to remove them. Those patients in whom stone
clearance was incomplete had a plastic stent placed to ensure biliary drainage, and
a second attempt at stone extraction was performed within 1 month.
Definitions
The success of DBE-assisted ERCP was defined as in previous studies [21]. DBE success was defined as viewing the papilla. ERCP success was defined as completion
of the intended ERCP intervention. Clinical success was defined as more than a 50 %
reduction in preprocedural abdominal pain, a 50 % reduction in hepatic enzyme levels
if they were elevated, resolution of cholangitis if it was present, and/or complete
extraction of bile duct stones if they existed. EPLBD was defined as 10-mm or greater
biliary orifice balloon dilation. Adverse events were categorized by using ERCP consensus
guidelines [22] and also included other adverse events that could be attributed specifically to
enteroscopy, such as peritoneal perforation, dysphagia, and/or odynophagia requiring
clinical follow-up.
Results
Overall double-balloon enteroscopy-assisted ERCP results
From April 2006 to December 2013, 77 patients (59 men, 18 women; mean age 73.5 ± 9.7,
range 50 – 95) underwent 92 DBE-assisted ERCP sessions. Of these, 24 patients (31 %)
had a past history of 2 or more abdominal surgeries. Procedure indications included
cholangitis (n = 43), bile duct stones (n = 9), malignant bile duct obstruction (n = 11),
pancreatitis (n = 6), abnormal liver enzyme levels associated with either abdominal
pain or dilated bile duct on noninvasive imaging (n = 6), and dilated bile duct alone
on imaging (n = 2). General anesthesia was used in 13 of 92 examinations (14 %), and
conscious sedation with meperidine and midazolam was provided for the rest of the
studies. The median procedure time was 80 minutes (range 60 – 120 minutes).
Long DBE was applied in the first 6 patients (6 ERCP sessions) and short DBE was used
for the remaining 71 patients (86 ERCP sessions). Mixed results of long and short
DBE-assisted ERCP were presented. DBE success was achieved in 73 of the 77 patients
(95 %), and 67 of these 73 patients (92 %) had ERCP success. By intention-to-treat
analysis, 67 of 77 patients (87 %) had DBE-assisted ERCP success. Among the 73 patients
with DBE success, 1 patient had peri-ampullary tumor and biliary cannulation failed.
Of the remaining 72 patients with a native papilla, 69 had successful biliary cannulation
(96 %) and 67 achieved ERCP success (93 %); 5 of the 69 (7 %) required precut needle-knife
papillotomy and 3 of the 69 (4 %) required percutaneous trans-hepatic cholangiography
rendezvous technique to achieve biliary cannulation. DBE-assisted ERCP was repeated
in 15 patients to complete bile duct stone clearance.
Therapeutic interventions were performed in 68 of the 69 patients ([Table 2]). The primary diagnoses in the patients with successful biliary cannulation were
bile duct stone (n = 49), cystic duct stone with Mirrizzi syndrome (n = 1), malignant
biliary stricture (n = 9), and biliary dilation alone (n = 9).
Table 2
Double-balloon enteroscopy-assisted ERCP interventions (n = 171).
|
Intervention
|
n
|
|
Endoscopic papillary balloon dilation
|
76
|
|
Common bile duct stone extraction
|
57
|
|
Biliary stenting (7 with metal stent)
|
19
|
|
Pancreatic stenting
|
1
|
|
Nasobiliary drainage
|
6
|
|
Precut needle-knife papillotomy, freehand
|
5
|
|
Rendezvous cannulation
|
3
|
|
Tumor sampling
|
4
|
|
Total
|
171
|
ERCP, endoscopic retrograde cholangiopancreatography.
The primary reason for DBE-assisted ERCP failure (n = 10) was failure to reach the
papilla (n = 4); 2 of these patients had tumor obstruction within the afferent limb
and the other 2 had peritoneal adhesion. The secondary reasons were failed cannulation
of a native papilla (n = 2) and failure to remove bile duct stone completely (n = 2).
Other reasons included peri-ampullary tumor preventing successful cannulation (n = 1)
and enteroscope-related intestinal perforation (n = 1).
Procedural complications developed in 5 of 77 patients (6.5 %) and included EPBD-related
minor perforation (n = 2), enteroscope/overtube-related intestinal mucosal tear (n = 2),
and enteroscope/overtube-related intestinal perforation (n = 1). No pancreatitis or
bleeding was noted. Most complications were treated nonoperatively (n = 4). Surgical
intervention was required in 1 patient with afferent limb perforation, and severe
adhesions were found during the operation. No mortality related to DBE-assisted ERCP
occurred.
Of the 68 patients who underwent therapeutic ERCP, clinical success per protocol was
achieved in 66 patients (97 %). Operative intervention was required in 2 patients
because of large bile duct stone. Clinical follow-up of more than 3 months was obtained
in the majority of those patients who had clinical success (49/66, 74 %), with a mean
time of 28 months (range 5 – 92 months). During follow-up, recurrence developed in
6 patients (12 %), which included recurrent common bile duct stones (n = 4), acute
calculous cholecystitis (n = 1), and debris obstruction within a biliary metal stent
(n = 1). An additional 4 DBE-assisted ERCPs were performed uneventfully.
The reported success and complicated rates in DBE-assisted ERCP series are summarized
in [Table 3].
Table 3
Comparison of results of double-balloon enteroscopy-assisted ERCP in series of patients
with Billroth II gastrectomy.
|
Study, first author
|
Patients,
n
|
ERCPs,
n
|
Mean age,
y
|
DBE success rate
|
ERCP success rate
|
Overall complication rate
|
DBE-related perforation rate
|
EPBD-related perforation rate
|
|
Shimatani [10]
|
17
|
22
|
NA
|
100 %
|
100 %
|
0 %
|
0 %
|
0 %
|
|
Cho [11]
|
6
|
NA
|
NA
|
100 %
|
NA
|
0 %
|
0 %
|
0 %
|
|
Osoegawa [12]
|
15
|
19
|
NA
|
95 %
(18/19)
|
84 %
(16/19)
|
5.3 %
(1/19)
|
5.3 %
(1/19)
|
0 %
|
|
Present study
|
77
|
92
|
73.5
|
95 %
(73/77)
|
87 %
(67/77)
|
6.5 %
(5/77)
|
1.3 %
(1/77)
|
2.6 %
(2/77)
|
ERCP, endoscopic retrograde cholangiopancreatography; DBE, double-balloon enteroscopy;
EPBD, endoscopic papillary balloon dilation; NA, not available.
Endoscopic papillary large-balloon dilation for the removal of bile duct stones
All patients who had bile duct stones (n = 49) were treated with EPBD alone without
sphincterotomy. EPBD with an 8-mm balloon was performed in 1 patient, who was excluded
from analysis. A total of 48 patients (14 women; mean age 75.5, range 54 – 95) with
bile duct stones who underwent 53 EPLBDs and 60 DBE-assisted ERCPs were identified.
All patients had a native papilla. Needle-knife precut was required in 3 patients
to aid biliary cannulation. Percutaneous trans-hepatic cholangiography rendezvous
technique was applied in another 3 patients to gain biliary access. A prophylactic
pancreatic stent was placed in 1 patient because of difficult cannulation.
The mean maximum transverse diameter of the largest stone was 12.2 mm (range 6 – 35 mm),
and the mean number of bile duct stones was 3 (range 1 – 8). The mean maximum diameter
of distal bile duct was 15.7 mm (range 9 – 35 mm). The mean size of the dilating balloon
was 13.1 mm (range 10 – 18 mm). Complete clearance of the bile duct stones in 1 DBE-assisted
ERCP session was achieved in 36 patients (75 %). In an additional 10 patients (21 %),
stones were successfully extracted in the second session. Mechanical lithotripsy was
used in 1 patient (2 %). Failure of stone clearance occurred in 2 patients (4 %),
both with a very large stone size (30 mm and 35 mm). These 2 patients had a biliary
stent placed to ensure biliary drainage and underwent surgical intervention.
Short-term complications were documented in 2 patients (4 %), in whom mild papillary
perforation developed after EPLBD with a 12-mm CRE balloon (patient had a maximum
stone size of 16 mm, maximum common bile duct caliber of 15 mm, and distal common
bile duct caliber of 12 mm) and after EPLBD with an 18-mm CRE balloon (patient had
a maximum stone size of 30 mm, maximum common bile duct caliber of 35 mm, and distal
common bile duct caliber of 18 mm). Both complications were identified during ERCP
procedures and treated uneventfully by endoscopic nasobiliary drainage and conservative
management. No procedure-related bleeding or pancreatitis was documented.
Long-term ( ≥ 6-month) follow-up data were available in 35 of 46 patients (76 %) with
complete removal of bile duct stones. The mean follow-up period was 32 months (range
6 – 92 months). During follow-up, 2 patients (5.7 %) developed recurrent bile duct
stones, which were successfully retrieved by DBE-assisted ERCP and EPLBD. Another
patient developed acute calculous cholecystitis 2 years after ERCP and underwent cholecystectomy.
The reported success and complication rates with EPLBD alone for the removal of bile
duct stones are summarized in [Table 4].
Table 4
Reported studies of endoscopic papillary large-balloon dilation alone for the removal
of bile duct stones.
|
Study, first author
|
Cases, n
|
Mean age, y
|
Anatomy
|
Balloon size, mm
|
Mean maximum stone size, mm
|
Rate of success in first treatment
|
Overall success rate
|
Use of lithotripsy
|
Recurrent
CBD stone
|
Overall complication rate
|
Post-ERCP pancreatitis rate
|
Post-EPLBD bleeding rate
|
Post-EPLBD perforation rate
|
|
Jeong [15]
|
38
|
68
|
Normal
|
15 – 18
|
17.7
|
66 %
|
97 %
|
21 %
|
NA
|
2.6 %
|
2.6 %
|
0 %
|
0 %
|
|
Chan [16]
|
247
|
71
|
Normal
|
> 10
|
16.4
|
82 %
|
93 %
|
16 %
|
14.5 % (30 mo)[1]
|
1.2 %
|
0.8 %
|
0 %
|
0 %
|
|
Oh [19]
|
40
|
72
|
Normal
|
10 – 18
|
13.2
|
82 %
|
98 %
|
10 %
|
NA
|
22.5 %
|
5 %
|
10 %
|
2.5 %
|
|
Hwang [17]
|
62
|
70
|
Normal
|
12 – 20
|
15.7
|
89 %
|
97 %
|
16 %
|
NA
|
6.5 %
|
6.5 %
|
0 %
|
0 %
|
|
Kogure [18]
|
28
|
77
|
Normal
|
12 – 18
|
14.0
|
89 %
|
96 %
|
11 %
|
11 % (22 mo)[2]
|
8 %
|
4 %
|
0 %
|
4 %
|
|
Present study
|
48
|
76
|
Billroth II
|
10 – 18
|
12.2
|
75 %
|
96 %
|
2 %
|
6 % (32 mo)[1]
|
4 %
|
0 %
|
0 %
|
4 %
|
CBD, common bile duct; ERCP, endoscopic retrograde cholangiopancreatography; EPLBD,
endoscopic papillary large-balloon dilation; NA, not available.
1 Mean follow-up period.
2 Median follow-up period.
Discussion
Since the first introduction of DBE-assisted ERCP in patients with surgically altered
GI anatomy in 2006 [8], many related studies have been published. However, most of the studies included
patients with Billroth II gastrectomy and a variety of Roux-en-Y altered anatomies.
The indications, procedural difficulties, and treatment outcomes of DBE-assisted ERCP
for Billroth II surgery and those for Roux-en-Y surgery are different. One systematic
review showed that the overall endoscopic and ERCP success rates of overtube-assisted
enteroscopy ERCP were highest in patients with Billroth II anatomy, next-highest in
those with pancreaticoduodenectomy and Roux-en-Y hepaticojejunostomy, and lowest in
patients with Roux-en-Y gastric bypass (endoscopic success rates of 96 % vs. 85 %
vs. 80 %; ERCP success rates of 90 % vs. 76 % vs. 70 %, respectively) [13]. The overall major complication rate of overtube-assisted enteroscopy ERCP was 3.4 %.
In this study, we present our experience of DBE-assisted ERCP in a large cohort of
patients with Billroth II gastrectomy. Our patients (n = 77) outnumbered those analyzed
in the review article (n = 57), and the results showed a DBE success rate of 95 %
and an ERCP success rate of 87 %, which were comparable with those of the published
meta-analysis.
The endoscopic management of patients who have undergone Billroth II gastrectomy is
challenging because of the altered anatomical features and postoperative adhesions.
The challenges to successful ERCP include difficulty in inserting an endoscope deeply
into the afferent loop, in inserting a catheter deeply and selectively into the bile
duct, and in performing therapeutic procedures safely. Although patients with Billroth
II gastrectomy can undergo ERCP with a standard duodenoscope or forward-viewing endoscope,
the endoscopic approach to the afferent loop and blind end is difficult in patients
with severe adhesions or a long afferent loop. DBE-assisted ERCP has been shown to
be a minimally invasive alternative to percutaneous trans-hepatic cholangiography
and surgery, with an acceptable risk profile in previous studies [10]
[11]
[12]. The reported success and complication rates of DBE-assisted ERCP in various series
are summarized in [Table 3]. A single-balloon overtube-assisted enteroscopy system has demonstrated similar
results in patients with Billroth II gastrectomy [23].
During Billroth II surgery, the proximal gastric stump is anastomosed in an end-to-side
fashion with a loop of jejunum. The afferent side of the loop is at a variable distance
from the ligament of Treitz and can be as short as 30 cm in a retrocolic anastomosis
but longer than 80 cm in an antecolic configuration. Most of our patients had undergone
antecolic, antiperistaltic reconstruction, and the identification and intubation of
the afferent limb were thus more difficult. In our previous study, ERCP success with
a duodenoscope was accomplished in 70 % of these patients, and the reasons for ERCP
failure included a sharp gastrojejunal anastomosis curve (6 %), a long afferent loop
(19 %), and duodenoscope-related bowel perforation (6 %) [9]. Advancement of the DBE into the afferent limb of a Billroth II anastomosis is easier,
given the short radius of curvature of the tip of the scope. The DBE system has two
balloons at the tip of the enteroscope and overtube, which allow the endoscopist to
hold the intestine and insert the enteroscope deeply while shortening the intestine
simultaneously. The push-and-pull manipulation helps overcome and shorten the tortuous
and long afferent loop. In the current study, the DBE successfully reached the papilla
in 95 % of the patients in whom the journey could not be completed with a standard
method. Instrument-related complications occurred in 3 patients and included 2 intestinal
mucosal tears and 1 perforation. Comparisons between our study and published ERCP
series of patients with Billroth II gastrectomy in whom a standard method was used
are summarized in [Table 5].
Table 5
Comparisons of ERCP studies in patients with Billroth II gastrectomy.
|
Study, first author
|
Cases, n
|
ERCPs, n
|
Endoscopy type
|
Mean/median age, y
|
Endoscopy success rate
|
ERCP success rate
|
Overall complication rate
|
Scope-related perforation rate
|
Treatment-related perforation rate
|
Treatment-related bleeding rate
|
Treatment-related pancreatitis rate
|
ERCP-related mortality rate
|
|
Faylona [2]
|
110
|
185
|
SD, EGD
|
72.1
|
72 % (134/185)
|
66 % (122/185)
|
8.1 % (15/185)
|
4.9 % (9/185)
|
1.1 % (2/185)
|
1.6 % (3/185)
|
0.5 % (1/185)
|
1.8 % (2/110)
|
|
Lin [5]
|
56
|
NA
|
SD, EGD
|
63
|
77 % (43/56)
|
63 % (35/56)
|
5.4 % (3/56)[1]
|
0 %
|
0 %
|
0 %
|
0 %
|
0 %
|
|
Swarnkar [3]
|
41
|
48
|
SD
|
75
|
87.5 % (42 /48)
|
85.4 % (41/48)
|
6.3 % (3 /48)
|
2 % (1 /48)
|
0 %
|
4.2 % (2 /48)
|
0 %
|
0 %
|
|
Ciçek [4]
|
59[2]
|
NA
|
SD
|
65.4 (simple Billroth II)
|
87 % (45/52)
|
83 % (43/52)
|
11.9 % (7/59)
|
10 % (6/59)
|
1.7 % (1/59)
|
0 %
|
1.7 % (1/59)
|
3.4 % (2/59)
|
|
Byun [6]
|
46
|
57
|
EGD
|
71
|
91 % (42/46)
|
91 % (42/46)
|
6.5 % (3/46)
|
0 %
|
2.2 % (1/46)
|
0 %
|
2.2 % (1/46)
|
0 %
|
|
Present study
|
77
|
92
|
DBE
|
73.5
|
95 % (73/77)
|
87 % (67/77)
|
6.5 % (5/77)
|
1.3 % (1/77)
|
2.6 % (2/77)
|
0 %
|
0 %
|
0 %
|
ERCP, endoscopic retrograde cholangiopancreatography; SD, side-viewing duodenoscope;
EGD, esophagogastroduodenoscope; NA, not available.
1 Submucosal hemorrhage occurred in 3 patients.
2 Including 52 patients with simple Billroth II gastrectomy and 7 patients with Billroth
II gastrectomy and Braun anastomosis.
Once the papilla has been reached, cannulation of the intact papilla with a forward-viewing
enteroscope is associated with two challenges in orientation – namely, working without
an elevator and approaching with a forward rather than a side view. Furthermore, proper
ERCP accessories should be chosen for different versions of the DBE. Standard accessories
can be applied to the short DBE system (EC-450 BI5); however, specialized accessories
are needed for the long DBE (EN-450 T5), as shown in [Table 1]. In our experience, a short DBE system can complete ERCP in all patients with Billroth
II gastrectomy and most patients with Roux-en-Y anastomosis. Given the lack of an
elevator, papillary cannulation is best achieved with a straight catheter and a guidewire.
Manipulation of both the overtube and the enteroscope makes it possible to change
the position of the papilla and to align the axes of a cannula and the bile duct.
Despite the unfavorable factors for cannulation, when the papilla is reached by DBE,
the ERCP technical success rates approached those seen in patients with intact GI
anatomy [10]
[21]. In our study, ERCP success was obtained in 92 % of the patients in whom the major
papilla was accessed by DBE.
Choledocholithiasis was the major final diagnosis in our series, and 49 of 69 patients
(71 %) with successful biliary cannulation underwent stone removal. Traditional BES
in patients with Billroth II gastrectomy is achieved with the use of a reversed-angle
sphincterotome or with placement of a stent followed by needle-knife sphincterotomy
over the stent. However, the size of the sphincterotomy is reduced because of poor
handling of the accessories and poor visualization of the upper margin of the papilla
roof secondary to its inverted location. Therefore, BES may be ineffective for the
removal of large bile duct stones. Furthermore, BES in patients with Billroth II gastrectomy
is associated with an increased risk of bleeding and perforation.
Alternatively, EPLBD after a partial BES is an acceptable option for the removal of
larger stones with minimized risk in patients who have Billroth II gastrectomy. The
safety and efficacy of BES followed by EPLBD have been demonstrated in several ERCP
series of patients with normal anatomy [24]
[25]
[26]. The reported rates of successful stone removal ranged from 89 % to 100 %, rates
of mechanical lithotripsy use from 1 % to 29 %, overall complication rates from 4 %
to 15.5 %, and post-ERCP pancreatitis rates from 0 % to 8 %. Most reported cases of
pancreatitis were mild. In a multicenter U.S. study, Attasaranya et al. reported the
use of BES followed by EPLBD (≥ 12 mm) and the selective use of mechanical lithotripsy
as an effective therapy for the removal of relatively large (≥ 10 mm) bile duct stones
[24]. The authors reported a 95 % complete stone clearance rate in one session with the
use of mechanical lithotripsy in 27 % of procedures. Teoh et al. further confirmed
that combined BES/EPLBD and BES alone cleared bile duct stones with equal efficacy;
however, combined therapy reduced the need for mechanical lithotripsy and the cost
of hospitalization [26]. Combined BES/EPLBD therapy was applied to ERCP in patients with Billroth II gastrectomy
with similar yields. Choi et al. reported a 100 % rate of stone removal and no complications
with combined BES and EPLBD (10 – to 15-mm balloon) in 26 patients with Billroth II
gastrectomy [14]. Mechanical lithotripsy was required in 12 % of these patients.
Contrary to the consistent findings of safety and efficacy with combined BES/EPLBD
therapy, controversy remains regarding EPBD without preceding BES for the removal
of bile duct stones. EPBD alone possesses the advantage of technical ease and less
bleeding. EPBD with a small balloon appears to preserve partial function of the sphincter
of Oddi over the medium term [27]. However, several prospective studies comparing small-diameter EPBD (≤ 8 mm) and
BES for the removal of bile duct stones reported a post-EPBD pancreatitis rate of
7 % to 15 % [28]
[29]
[30]. One prospective randomized multicenter U.S. study showed a significantly higher
overall complication rate in the small-diameter EPBD group than in the BES group (17.9 %
vs. 3.3 %), in addition to a higher acute pancreatitis rate (15.4 % vs. 0.8 %), including
2 deaths from severe pancreatitis in the EPBD group [30]. The authors claimed that the post-ERCP pancreatitis was probably due to edematous
change or trauma after the dilation procedure, resulting in obstruction of the pancreatic
duct. However, recent studies (all from Asia) reported that EPLBD alone (≥ 10 – 12 mm)
can have a high rate of successful stone clearance, with fewer complications (including
pancreatitis), and can minimize the use of mechanical lithotripsy [15]
[16]
[17]
[18]
[19]. The efficacy and safety profile of EPLBD alone in published series, shown in [Table 4], is similar to that of the aforementioned combined BES/EPLBD method.
The discrepancy between the treatment outcomes of small- and large-diameter EPBD is
probably related to the “created size” of the biliary orifice rather than to the dilation
procedure itself. EPBD with a small balloon requires the addition of laborious procedures
that are traumatic to the papilla, such as mechanical lithotripsy, to remove large
stones successfully, which can lead to the development of complications like pancreatitis
and cholangitis. Large-balloon dilation results in the permanent loss of sphincter
function and a large biliary opening, which can prevent accidental cannulation of
the pancreatic duct during the subsequent stone extraction and stone impaction in
the common duct. Consequently, there is less need to apply mechanical lithotripsy
than in small-diameter EPBD. Thus, the main purpose of EPLBD in endotherapy is to
avoid additive therapeutic procedures, simplify the process of stone extraction, and
reduce the complication rate. Simplifying treatment procedures while maintaining the
efficacy of stone removal is especially important in the removal of difficult bile
duct stones, such as those in patients with Billroth II gastrectomy. Itoi et al. reported
that combined BES/EPLBD therapy reduced ERCP procedure time and fluoroscopy time in
comparison with BES alone [25].
A unique feature of our series is that it is the first report of patients with Billroth
II gastrectomy and bile duct stones undergoing both DBE-assisted ERCP and therapy
with EPLBD alone. We found that the success rate of bile duct clearance after EPLBD
was high, although additional sessions may be needed to secure the result. The adverse
events of EPLBD in these patients are acceptable. Although combined BES and EPLBD
therapy is safe and effective in treating patients with Billroth II anatomy and bile
duct stones, we cannot provide such information because of the study design. The other
limitation of our study is the retrospective analysis, which may have contributed
to an underestimation of the complication rate. In addition, many older patients were
included in this study, whose risk of post-ERCP pancreatitis may be small.
In conclusion, our investigation suggests that ERCP is successful in a majority of
patients with Billroth II gastrectomy when an advanced overtube-assisted DBE technique
is performed at a tertiary care center. EPLBD can be performed with equal efficacy
and safety in patients with Billroth II gastrectomy. Given the acceptable risk profile
and long-term follow-up results, DBE-assisted ERCP should be considered as an alternate
therapy when traditional ERCP has failed, and EPLBD as a standard therapy for difficult
bile duct stones in patients with Billroth II gastrectomy.
