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Emergency endoscopic needle-knife precut papillotomy in acute severe cholangitis resulting from impacted common bile duct stones at duodenal papilla
Accepted Manuscript Title: Emergency endoscopic needle-knife precut papillotomy in acute severe cholangitis resulting from impacted common bile duct stones at duodenal papilla Authors: Mingwei Zheng, Xufeng Liu, Ning Li, Wei-Zhi Li PII: DOI: Reference:
S1590-8658(17)31311-7 https://doi.org/10.1016/j.dld.2017.11.015 YDLD 3599
To appear in:
Digestive and Liver Disease
Received date: Revised date: Accepted date:
25-12-2016 21-11-2017 21-11-2017
Please cite this article as: Zheng Mingwei, Liu Xufeng, Li Ning, Li Wei-Zhi.Emergency endoscopic needle-knife precut papillotomy in acute severe cholangitis resulting from impacted common bile duct stones at duodenal papilla.Digestive and Liver Disease https://doi.org/10.1016/j.dld.2017.11.015 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title: Emergency endoscopic needle-knife precut papillotomy in acute severe cholangitis resulting from impacted common bile duct stones at duodenal papilla
IP T
Running title: Papillotomy for cholangitis
SC R
Authors: Mingwei Zheng1, 2, M.D., Ph.D.; Xufeng Liu3, Ph.D.; Ning Li1, Ph.D;
U
Wei-Zhi Li 1, Ph.D;.
N
1: Department of Surgery, Tianjin Nankai Hospital, Tianjin, China
A
2: Tianjin Medical University, Tianjin 300100, China
M
3: Department of Surgery, Tianjin Dagang Oilfield General Hospital, Tianjin
TE D
300280, China
AUTHOR FOR CORRESPONDENCE:
EP
Ning Li, Department of Surgery, Tianjin Nankai Hospital
CC
No. 6, Chang Jiang Road, Nankai District Tianjin, 300100
A
CHINA
Ph: +86 139 2051 5154 Fax: +86 22 2743 5266 Email: [email protected]
Abstract AIM: To evaluate the efficacy and safety of emergency endoscopic needle-knife precut papillotomy in acute severe cholangitis resulting from
IP T
impacted common bile duct stones at duodenal papilla. METHODS: Between January 2010 and January 2015, 118 cases of acute
papilla
underwent
SC R
severe cholangitis with impacted common bile duct stones at the native emergency
endoscopic
retrograde
U
cholangiopancreatography (ERCP) and early needle-knife precut papillotomy
N
in a tertiary referral center. Precut techniques were performed according to
A
the different locations of stones in the duodenal papilla. Clinical data about
M
therapy and recovery of the 118 patients were recorded and analyzed.
TE D
RESULTS: One hundred and eighteen patients underwent emergency ERCP within 24 h after hospitalization, with a total success rate of 100%. The mean operating time was 6.4 ± 4.1 min. Postoperative acute physiology and chronic
EP
health evaluation (APACHE) II scores, white blood cell count and liver
CC
function improved significantly. The complication rate was 4.2% (5/118); two with hemorrhage and three with acute pancreatitis. There was no
A
procedure-related mortality. CONCLUSION: Emergency endoscopic needle-knife precut papillotomy is effective and safe for acute severe cholangitis resulting from impacted common bile duct stones at the duodenal papilla.
Keywords: Emergency endoscopic needle-knife precut papillotomy; Acute severe cholangitis; Impacted common bile duct stones; Endoscopic retrograde cholangiopancreatography
IP T
INTRODUCTION Acute cholangitis of severe type (ACST) is a common serious disease that is
SC R
usually caused by bile duct stones. ACST breaks out violently and rapidly
develops into septic shock and multiple organ failure, which have high
procedure
for
ACST.
Recently,
endoscopic
retrograde
N
essential
U
mortality [1]. Successful drainage of the common bile duct (CBD) is an
A
cholangiopancreatography (ERCP) has been used extensively for treatment of
M
pancreaticobiliary diseases, and many studies have reported endoscopic
TE D
biliary cannulation for safe and effective CBD drainage [2-5]. However, when the CBD stones become impacted at the duodenal papilla, the papillary orifice is blocked almost completely and standard biliary cannulation is difficult.
EP
Endoscopic needle-knife precut papillotomy (NKPP) is usually a rescue
CC
technique in difficult biliary cannulation and associated with a high risk of
A
complications including hemorrhage, perforation and pancreatitis [6]. Our retrospective study was designed to evaluate the efficacy and safety
of emergency NKPP in patients with ACST with CBD stones impacted at native papilla. We also summarize the techniques for simplifying endoscopic procedures in NKPP.
MATERIALS AND METHODS Between January 2010 and January 2015, 6847 ERCPs were performed at our center, which included 118 cases of ACST with CBD stones impacted at the
IP T
native papilla that underwent emergency NKPP. All 118 patients underwent ultrasonography and computed tomography
SC R
to identify impacted stones at the papilla preoperatively. Magnetic resonance
cholangiopancreatography was performed in 23 patients. The study was
N
was obtained from all patients before ERCP.
U
approved by the institutional ethical committee and written informed consent
A
The inclusion criteria were as follows: (1) clinical symptoms: typical
M
Charcot’s triad (including right upper abdominal pain, jaundice, fever usually
TE D
with rigor), accompanied by septic shock and/or mental confusion (Reynold’s pentad); (2) native papilla without endoscopic incision; and (3) endoscopic
EP
observation of impacted stones at the papilla. The exclusion criteria were as follows: (1) age < 18 years; (2) surgically
CC
altered anatomy (Roux-en-Y anastomosis, Billroth II gastrectomy); (3) neoplasm in the duodenum, papilla or pancreas; (4) severe multiple organ
A
failure, such as congestive heart failure, respiratory failure, uncontrolled coagulopathy; (5) refusal to approve the study protocols. The excluded patients with ACST underwent percutaneous transhepatic cholangial drainage.
The patients were divided into three groups according to different stone locations at the duodenal papilla, observed by ERCP: CBD stones impacted at the papillary orifice (Group A), central papilla (Group B), and roof of the
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papilla (Group C).
Endoscopic precut procedure
SC R
Patients were placed in the left-lateral position, and under conscious sedation or general anesthesia, the duodenoscope (Fujinon ED-250XT5, Japan) was
U
inserted into the descending duodenum. The papilla was observed closely by
N
endoscopy. An edematous papilla with obviously high tension usually
A
indicated stone impaction. The position of the impacted stones could be
M
determined approximately according to the bulging notch at the papilla.
TE D
Impacted stones shifted the papilla downward and made deep CBD cannulation difficult to complete. So, under these conditions, standard endoscopic cannulation was not attempted and early NKPP was performed
EP
immediately.
CC
When the impacted stones were at the papillary orifice, the orifice opened widely toward the endoscope and sometimes the stone could be seen
A
ambiguously through the orifice. Early NKPP was performed using a needle-knife sphincterotome with an endocut current mode (ERBE generator, icc200, ERBE Elektromedizin Ltd. Germany), and starting from the anterior wall of the papillary orifice, NKPP proceeded upward to the 11–12 o’clock
position layer by layer. When stones were impacted at the central papilla, the papilla was enlarged and dilated like the symbol “”. The papillary orifice opened toward the distal duodenal lumen and was difficult to be seen by endoscopy.
IP T
In this condition, superior bulging notch was selected as the starting point for NKPP. The papillotomy was performed downward until the orifice was
SC R
reached.
When stones were impacted at the roof of the papilla, NKPP started from
U
the papillary orifice and was oriented toward the papillary root layer by layer.
N
The movement of the needle-knife sphincterotome was similar to a pendulum
A
swing within a small range to avoid excessive precutting. Repeated precut
M
procedures were performed upward until the papillary root was reached.
TE D
Usually, the impacted stones could be pushed into the duodenal lumen by hyperbaric bile when the corresponding NKPP was accomplished. The
EP
biliary duct orifice was exposed sufficiently, and then CBD cannulation could be performed. In our study, an endoscopic nasal biliary drainage (ENBD) tube
CC
was inserted into the CBD along the guide wire and no further stone
A
extraction procedures were performed.
Postoperative management and observation parameters Patients were placed in the prone position under the electrocardiography monitor for > 6 h postoperatively. Broad-spectrum antibiotics were
administered depending on bacterial culture and drug sensitivity testing of blood or bile. Somatostatin was used for prevention of post-ERCP pancreatitis. Clinical data about the operation and recovery were monitored,
IP T
including white blood cell count (WBC), procalcitonin (PCT) level, liver function, including total bilirubin, direct bilirubin, alanine aminotransferase
SC R
and acute physiology and chronic health evaluation (APACHE) II scores. The operating time was defined as the duration between the endoscope entering
U
the mouth to successful CBD cannulation. The postoperative complications
M
Statistical analysis
A
N
were also recorded.
TE D
Continuous variables were described as the mean ± standard deviation and compared using Student’s t test. Fisher’s exact test was used for categorical
EP
variables. Comparisons were considered statistically significant when P
CC
values were < 0.05.
RESULTS
A
One hundred and eighteen patients were included in our study. Emergency ERCP was performed within 24 h after hospitalization. The mean age of the patients was 68.7 ± 24.1 years, and 76 cases were male. The clinical characteristics of the 118 patients are listed in Table 1.
Endoscopic observation found CBD stones impacted at the papillary orifice in 53 cases, at the central papilla in 36 cases, and at the roof of the papilla in 29 cases. The success rate of NKPP and CBD cannulation was 100%. The mean operating time was 6.4 ± 4.1 min. The clearance rate of impacted
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stones in emergency ERCP was 94.9% (112/118). The other six cases all had stones at the papillary roof, and after NKPP revealed the orifice of the CBD,
SC R
cannulation was performed first. No further stone extractions were carried
out. The stones in these six cases were cleared by a second ERCP. Three
U
patients underwent pancreatic duct stent drainage for prevention of acute
N
severe pancreatitis.
A
The total complication rate was 4.2% (5/118); two cases with hemorrhage
M
and three with acute pancreatitis. One case of acute pancreatitis occurred in
TE D
Group A. One case of hemorrhage occurred in Group B. One case of hemorrhage and two of acute pancreatitis occurred in Group C. The
EP
complication rate in each group did not differ significantly. The two cases of hemorrhage were cured by endoscopic hemostasis, and the three cases of
CC
acute pancreatitis were cured conservatively. There was no procedure-related
A
mortality. The outcomes of the three groups are shown in Table 2. The clinical data about the recovery were monitored for 48 h
postoperatively. Compared to preoperative data, postoperative WBC, PCT level, liver function and APACHE II scores improved significantly (Table 3). All patients underwent blood or bile bacterial culture and 87 cases were
positive: Escherichia coli in 66 cases, Staphylococcus epidermidis in 15, Pseudomonas aeruginosa in 37, Bacillus fragilis in 23, Bacillus proteus in nine, and Klebsiella pneumoniae in 17.
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DISCUSSION ACST is a challenge for physicians. Biliary duct obstruction results in
SC R
increased internal pressure and a backflow of bacteria and endotoxins in the CBD, which causes bacterial colonization and severe systemic infection. ACST
U
can develop rapidly into septic shock and multiple organ failure, which are
N
severe complications with high mortality, especially for elderly patients.
A
Surgical biliary duct drainage should be performed as soon as possible
M
[7]. Conventional surgery involves common bile duct exploration, with T tube
TE D
drainage. In elderly patients, especially those with one or more comorbidities, the operation is difficult because of surgical trauma and high risk [8]. In our
EP
study, the mean age of the 118 patients was 68.7 years and 86.4% (102/118) had a history of comorbidity.
CC
As endoscopic techniques have developed rapidly, endoscopic biliary duct drainage has become the optimal management strategy and has been
A
widely accepted. Impacted CBD stone at the papilla is one factor that makes cannulation difficult for conventional ERCP [3]. Under these conditions, duodenal papillae were swollen with edema. The orifice was reduced in size and was blocked completely, so that the standard cannulation of the CBD was
difficult. And repeated cannulations are a risk factor for post-ERCP pancreatitis [9, 10]. Early NKPP was a reasonable choice for the difficult situation. NKPP is used as a rescue technique for difficult biliary cannulation, although it is
IP T
usually associated with a high risk of complications including hemorrhage, perforation and pancreatitis [11-13]. However, many recent studies have
SC R
reported that the complication rate of precut papillotomy is not significantly different compared to that of conventional papillotomy [14-16]. Kaffes et al
U
[15] reported that 70 cases underwent NKPP with a success rate of 93%, and
N
the rate of complications did not differ from that of conventional papillotomy.
A
They proposed early introduction of precut techniques for difficult biliary
M
cannulation.
TE D
Impacted stones at the papilla resulted in bulging of the sphincter of Oddi and the pancreatic duct orifice was walled off from the anterior wall of
EP
the sphincter. So, it is important for NKPP to choose a suitable starting site and corresponding papillotomy after establishing the location of the impacted
CC
stones, which could reduce the risk of perforation and post-ERCP pancreatitis as much as possible. ACST with systemic infection usually results in
A
abnormal coagulation, as well as papillary edema, which increase the risk of hemorrhage. Therefore, NKPP should be performed slowly and steadily, layer by layer, so that the incised margin could stop bleeding reliably [17]. In our study, the success rate of NKPP and CBD cannulation was 100%. The total
complication rate was 4.2% (5/118), with two cases of hemorrhage and three of acute pancreatitis, which did not differ significantly from the literature [14-16, 18, 19]. There was no procedure-related mortality. The mean operating time was 6.4 ± 4.1 min. The operating time was
IP T
shorter in Groups A and B compared with Group C. For Group C (stones impacted at the roof of the papilla), NKPP started from the papillary orifice
SC R
and was oriented toward the papillary root, layer by layer. The movement of
the needle-knife sphincterotome should be small, like a pendulum, when near
U
the roof of the papilla because impacted stones cause overextension of the
N
anterior wall of the Oddi’s sphincter, and the papilla retracts after stone
A
removal. It was necessary to preserve the distance between the roof of the
M
papilla and the extent of the papillotomy to avoid irreversible perforation
TE D
resulting from excessive papillotomy. So, when stones were impacted at the roof of the papilla, the NKPP procedure was more complex and had a higher
EP
risk of perforation, although the complication rate of the three groups did not differ significantly.
CC
For ACST, the endoscopic procedures should be simplified to reduce operating time and complication risk as much as possible [7, 20]. Biliary duct
A
drainage was the main aim and it was not necessary to clear up all the CBD stones during the procedures. After NKPP, most of the impacted stones could be pushed into the duodenal lumen by hyperbaric bile. The clearance rate of impacted stones in emergency ERCP was 94.9% (112/118). The other six cases
all had stones at the papillary roof that were removed by the second ERCP. After successful cannulation, contrast agent should be injected at low pressure and then aspirated out to prevent bacterial backflow and infection. In our study, an ENBD tube was inserted into the CBD along the guide
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wire after successful cannulation. The infected bile was drained from the nasal tube and underwent bacterial culture. The sensitive antibiotic was used.
SC R
The effect of ENBD was not only to drain bile and sustain the papillary orifice, but also to avoid stones or viscous infected bile blocking biliary drainage by
U
antibiotic saline douching [21, 22].
N
Postoperative WBC and PCT level were significantly decreased
A
compared with preoperatively, which indicated that the infection improved
M
gradually. Liver function also improved after NKPP. APACHE II scores were
TE D
widely used to assess the severity and prognosis of patients. Postoperative APACHE II scores significantly decreased from 13.2 ± 7.3 to 7.7 ± 3.2, which
EP
indicated improvement in the patients’ systemic condition. In conclusion, emergency NKPP can be an effective and safe procedure
CC
for ACST resulting from impacted CBD stones at the duodenal papilla. Precut papillotomy procedure is chosen according to the location of the stones at the
A
papilla. Further prospective randomized controlled studies are still needed.
Conflict of interest statement: no commercial relationships that might pose a conflict of interest in connection with the submitted manuscript need be
A
CC
EP
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M
A
N
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disclosed.
REFERENCES [1] Mosler P. Diagnosis and management of acute cholangitis. Curr Gastroenterol Rep 2011; 13:166–72.
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[2] Caddy GR, Tham TC. Gallstone disease: Symptoms, diagnosis and endoscopic management of common bile duct stones. Best Pract Res Clin
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Gastroenterol 2006; 20: 1085-101.
[3] Joo KR, Cha JM, Jung SW, et al. Case review of impacted bile duct stone at
U
duodenal papilla: detection and endoscopic treatment．Yonsei Med J 2010;
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51: 534-9.
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[4]Freeman ML, Guda NM. ERCP cannulation: a review of reported
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techniques. Gastrointest Endosc 2005; 61:112–25.
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[5] Hao F, Zheng M, Qin M. The Effect of Endoscopic Ultrasonography in Treatment of Distal Inflammatory Biliary Stricture: A Retrospective
EP
Analysis of 165 Cases. Hepatogastroenterology 2014 Nov-Dec; 61: 2177-80. [6] Freeman ML, Nelson DB, Sherman S, et al. Complications of endoscopic
CC
biliary sphincterotomy. N Engl J Med 1996; 335:909–18.
A
[7] Kimura Y, Takada T, Strasberg SM, et al. TG13 current terminology, etiology, and epidemiology of acute cholangitis and cholecystitis. Journal of Hepato-Biliary-Pancreatic Sciences 2013; 20:8–23. [8]
JOSHI
RM,
SHETTY
TS,
ADHIKARI
DR, Singh
R,
et
Choledocholithiasis: endotherapy versus surgery. Int Surg 2010; 95:95-9.
al.
[9] Freeman ML, DiSario JA, Nelson DB, et al. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc 2001; 54: 425-34. [10] Bailey AA, Bourke MJ, Kaffes AJ, et al. Needle-knife sphincterotomy:
(with video). Gastrointest Endosc 2010; 71: 266–71.
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Factors predicting its use and the relationship with post-ERCP pancreatitis
complications. Curr Gastroenterol 2001; 3: 147-53.
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[11] Larkin CJ, Huibregtse K. Precut sphincterotomy: indications, pitfalls, and
U
[12] Tae Hoon Lee, Byoung Wook Bang, Sang-Heum Park, et al. Precut
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Fistulotomy for Difficult Biliary Cannulation: Is It a Risky Preference in
A
Relation to the Experience of an Endoscopist? Dig Dis Sci 2011; 56:
M
1896–903.
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[13] Foutch PG. A prospective assessment of results for needle-knife papillotomy and standard endoscopic sphincterotomy. Gastrointest
EP
Endosc 1995; 41:25–32.
[14] Robison LS, Varadarajulu S, Wilcox CM. Safety and success of precut
CC
biliary sphincterotomy: Is it linked to experience or expertise? World J Gastroenterol 2007; 13: 2183–6.
A
[15] Kaffes AJ, Sriram PV, Rao GV, et al. Early institution of precutting for difficult biliary cannulation: a prospective study comparing conventional vs. a modified technique. Gastrointest Endosc 2005; 62: 669-74. [16] Lee TH, Hwang SO, Choi HJ, et al. Sequential algorithm analysis to
facilitate selective biliary access for difficult biliary cannulation in ERCP: a prospective clinical study. BMC Gastroenterology 2014; 14(1): 1-8. [17] Artifon EL, Da SE, Aparicio D, et al. Management of common bile duct stones in cirrhotic patients with coagulopathy: a comparison of
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supra-papillary puncture and standard cannulation technique. Dig Dis Sci 2011; 56: 1904-11.
SC R
[18] Kasmin FE, Cohen D, Batra S, et al. Needle-knife sphincterotomy in a tertiary referral center: efficacy and complications. Gastrointest Endosc
U
1996; 44: 48-53.
safe
and
effective
technique
A
a
N
[19] Katsinelos P, Mimidis K, Paroutoglou G, et al. Needle-knife papillotomy: in
experienced
hands.
M
Hepatogastroenterology 2004; 51: 349-52.
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[20] Miura F, Takada T, Strasberg SM, et al. TG13 flowchart for the management of acute cholangitis and cholecystitis. J Hepatobiliary
EP
Pancreat Sci 2013; 20: 47-54.
[21] Lee DW, Chan AC, Lam YH, et al. Biliary decompression by nasobiliary
CC
catheter or biliary stent in acute suppurative cholangitis: a prospective randomized trial. Gastrointest Endosc 2002; 56: 361-5.
A
[22] Park SY, Park CH, Cho SB, et al. The safety and effectiveness of endoscopic biliary decompression by plastic stent placement in acute suppurative cholangitis compared with nasobiliary drainage. Gastrointest Endosc 2008 Dec; 68: 1076-80.
76/42
Age (yr) (mean ± SD)
68.7 ± 24.1
Charcot triad
118
Reynolds and Dargan pentad
53 (44.9%)
Gallstone pancreatitis
27 (22.9%)
Cholecystolithiasis
75 (63.6%)
U
SC R
Gender, M/F
N
Comorbidity history
M
A
Coronary heart disease Hypertension
IP T
Table 1 Clinical characteristics of 118 patients
TE D
Chronic obstructive pulmonary disease
46 52 17 44
Cerebral infarction
31
EP
Diabetes mellitus
13
Hepatic cirrhosis
11
Renal insufficiency
5
A
CC
Cerebral hemorrhage
The median duration of ACST (h)
15.7 (range, 3–48)
ACST, acute cholangitis of severe type; F, female; M, male. Table 2 Outcomes of NKPP for each group Group A
Group B
Group C
P value
Operating
53
36
29
3.4±2.8
4.6±3.7
8.2±5.5
P1 = 0.085 P2 = 0.0025
time (min)
P3 < 0.0001
Success of
100%
100%
100%
100%
100%
79.3%
Disimpaction rate of
IP T
cannulation
P2 < 0.0001
(23/29)
P3 < 0.0001
SC R
impacted stones Complications
1.9%
Acute
(1/53)
P1 = 0.4045
(1/36)
N
P2 = 1.0
0
(1/29)
P3 = 0.3537
6.9%
P1 = 1.0
(2/29)
P2 = 0.1952
TE D
pancreatitis
3.4%
A
Hemorrhage
2.8%
M
0
U
(%)
P3 = 0.2842
EP
P1: comparison between Groups A and B; P2: comparison between Groups B and C; P3: comparison between Groups A and C.
A
CC
Table 3 Comparison of clinical data before and after NKPP
WBC
Before
0.05)
P
11.2 ± 5.1
< 0.0001
4.32 ± 3.11
< 0.0001
NKPP 15.8 ± 4.3
PCT (ng/mL, normal range <
48 h after NKPP
9.38 ± 4.25
TBIL (μmol/L) (normal range,
54.6 ± 22.7
< 0.0001
35.7 ± 18.4
< 0.0001
78.2 ± 35.1
< 0.0001
83.4 ± 37.7
5.1–20.4) DBIL (μmol/L ) (normal range,
61.1 ± 21.8
ALT (U/L) 128.9 ± 46.7
5–40) APACHE II scores
7.7 ± 3.2
13.2 ± 7.3
SC R
(normal range,
IP T
1.7–6.8)
< 0.0001
A
CC
EP
TE D
M
A
N
U
ALT, alanine aminotransferase; APACHE II, acute physiology and chronic health evaluation II; DBIL, direct bilirubin; PCT, procalcitonin; TBIL, total bilirubin; WBC, white blood cell count.
S1590-8658(17)31311-7 https://doi.org/10.1016/j.dld.2017.11.015 YDLD 3599
To appear in:
Digestive and Liver Disease
Received date: Revised date: Accepted date:
25-12-2016 21-11-2017 21-11-2017
Please cite this article as: Zheng Mingwei, Liu Xufeng, Li Ning, Li Wei-Zhi.Emergency endoscopic needle-knife precut papillotomy in acute severe cholangitis resulting from impacted common bile duct stones at duodenal papilla.Digestive and Liver Disease https://doi.org/10.1016/j.dld.2017.11.015 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title: Emergency endoscopic needle-knife precut papillotomy in acute severe cholangitis resulting from impacted common bile duct stones at duodenal papilla
IP T
Running title: Papillotomy for cholangitis
SC R
Authors: Mingwei Zheng1, 2, M.D., Ph.D.; Xufeng Liu3, Ph.D.; Ning Li1, Ph.D;
U
Wei-Zhi Li 1, Ph.D;.
N
1: Department of Surgery, Tianjin Nankai Hospital, Tianjin, China
A
2: Tianjin Medical University, Tianjin 300100, China
M
3: Department of Surgery, Tianjin Dagang Oilfield General Hospital, Tianjin
TE D
300280, China
AUTHOR FOR CORRESPONDENCE:
EP
Ning Li, Department of Surgery, Tianjin Nankai Hospital
CC
No. 6, Chang Jiang Road, Nankai District Tianjin, 300100
A
CHINA
Ph: +86 139 2051 5154 Fax: +86 22 2743 5266 Email: [email protected]
Abstract AIM: To evaluate the efficacy and safety of emergency endoscopic needle-knife precut papillotomy in acute severe cholangitis resulting from
IP T
impacted common bile duct stones at duodenal papilla. METHODS: Between January 2010 and January 2015, 118 cases of acute
papilla
underwent
SC R
severe cholangitis with impacted common bile duct stones at the native emergency
endoscopic
retrograde
U
cholangiopancreatography (ERCP) and early needle-knife precut papillotomy
N
in a tertiary referral center. Precut techniques were performed according to
A
the different locations of stones in the duodenal papilla. Clinical data about
M
therapy and recovery of the 118 patients were recorded and analyzed.
TE D
RESULTS: One hundred and eighteen patients underwent emergency ERCP within 24 h after hospitalization, with a total success rate of 100%. The mean operating time was 6.4 ± 4.1 min. Postoperative acute physiology and chronic
EP
health evaluation (APACHE) II scores, white blood cell count and liver
CC
function improved significantly. The complication rate was 4.2% (5/118); two with hemorrhage and three with acute pancreatitis. There was no
A
procedure-related mortality. CONCLUSION: Emergency endoscopic needle-knife precut papillotomy is effective and safe for acute severe cholangitis resulting from impacted common bile duct stones at the duodenal papilla.
Keywords: Emergency endoscopic needle-knife precut papillotomy; Acute severe cholangitis; Impacted common bile duct stones; Endoscopic retrograde cholangiopancreatography
IP T
INTRODUCTION Acute cholangitis of severe type (ACST) is a common serious disease that is
SC R
usually caused by bile duct stones. ACST breaks out violently and rapidly
develops into septic shock and multiple organ failure, which have high
procedure
for
ACST.
Recently,
endoscopic
retrograde
N
essential
U
mortality [1]. Successful drainage of the common bile duct (CBD) is an
A
cholangiopancreatography (ERCP) has been used extensively for treatment of
M
pancreaticobiliary diseases, and many studies have reported endoscopic
TE D
biliary cannulation for safe and effective CBD drainage [2-5]. However, when the CBD stones become impacted at the duodenal papilla, the papillary orifice is blocked almost completely and standard biliary cannulation is difficult.
EP
Endoscopic needle-knife precut papillotomy (NKPP) is usually a rescue
CC
technique in difficult biliary cannulation and associated with a high risk of
A
complications including hemorrhage, perforation and pancreatitis [6]. Our retrospective study was designed to evaluate the efficacy and safety
of emergency NKPP in patients with ACST with CBD stones impacted at native papilla. We also summarize the techniques for simplifying endoscopic procedures in NKPP.
MATERIALS AND METHODS Between January 2010 and January 2015, 6847 ERCPs were performed at our center, which included 118 cases of ACST with CBD stones impacted at the
IP T
native papilla that underwent emergency NKPP. All 118 patients underwent ultrasonography and computed tomography
SC R
to identify impacted stones at the papilla preoperatively. Magnetic resonance
cholangiopancreatography was performed in 23 patients. The study was
N
was obtained from all patients before ERCP.
U
approved by the institutional ethical committee and written informed consent
A
The inclusion criteria were as follows: (1) clinical symptoms: typical
M
Charcot’s triad (including right upper abdominal pain, jaundice, fever usually
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with rigor), accompanied by septic shock and/or mental confusion (Reynold’s pentad); (2) native papilla without endoscopic incision; and (3) endoscopic
EP
observation of impacted stones at the papilla. The exclusion criteria were as follows: (1) age < 18 years; (2) surgically
CC
altered anatomy (Roux-en-Y anastomosis, Billroth II gastrectomy); (3) neoplasm in the duodenum, papilla or pancreas; (4) severe multiple organ
A
failure, such as congestive heart failure, respiratory failure, uncontrolled coagulopathy; (5) refusal to approve the study protocols. The excluded patients with ACST underwent percutaneous transhepatic cholangial drainage.
The patients were divided into three groups according to different stone locations at the duodenal papilla, observed by ERCP: CBD stones impacted at the papillary orifice (Group A), central papilla (Group B), and roof of the
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papilla (Group C).
Endoscopic precut procedure
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Patients were placed in the left-lateral position, and under conscious sedation or general anesthesia, the duodenoscope (Fujinon ED-250XT5, Japan) was
U
inserted into the descending duodenum. The papilla was observed closely by
N
endoscopy. An edematous papilla with obviously high tension usually
A
indicated stone impaction. The position of the impacted stones could be
M
determined approximately according to the bulging notch at the papilla.
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Impacted stones shifted the papilla downward and made deep CBD cannulation difficult to complete. So, under these conditions, standard endoscopic cannulation was not attempted and early NKPP was performed
EP
immediately.
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When the impacted stones were at the papillary orifice, the orifice opened widely toward the endoscope and sometimes the stone could be seen
A
ambiguously through the orifice. Early NKPP was performed using a needle-knife sphincterotome with an endocut current mode (ERBE generator, icc200, ERBE Elektromedizin Ltd. Germany), and starting from the anterior wall of the papillary orifice, NKPP proceeded upward to the 11–12 o’clock
position layer by layer. When stones were impacted at the central papilla, the papilla was enlarged and dilated like the symbol “”. The papillary orifice opened toward the distal duodenal lumen and was difficult to be seen by endoscopy.
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In this condition, superior bulging notch was selected as the starting point for NKPP. The papillotomy was performed downward until the orifice was
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reached.
When stones were impacted at the roof of the papilla, NKPP started from
U
the papillary orifice and was oriented toward the papillary root layer by layer.
N
The movement of the needle-knife sphincterotome was similar to a pendulum
A
swing within a small range to avoid excessive precutting. Repeated precut
M
procedures were performed upward until the papillary root was reached.
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Usually, the impacted stones could be pushed into the duodenal lumen by hyperbaric bile when the corresponding NKPP was accomplished. The
EP
biliary duct orifice was exposed sufficiently, and then CBD cannulation could be performed. In our study, an endoscopic nasal biliary drainage (ENBD) tube
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was inserted into the CBD along the guide wire and no further stone
A
extraction procedures were performed.
Postoperative management and observation parameters Patients were placed in the prone position under the electrocardiography monitor for > 6 h postoperatively. Broad-spectrum antibiotics were
administered depending on bacterial culture and drug sensitivity testing of blood or bile. Somatostatin was used for prevention of post-ERCP pancreatitis. Clinical data about the operation and recovery were monitored,
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including white blood cell count (WBC), procalcitonin (PCT) level, liver function, including total bilirubin, direct bilirubin, alanine aminotransferase
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and acute physiology and chronic health evaluation (APACHE) II scores. The operating time was defined as the duration between the endoscope entering
U
the mouth to successful CBD cannulation. The postoperative complications
M
Statistical analysis
A
N
were also recorded.
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Continuous variables were described as the mean ± standard deviation and compared using Student’s t test. Fisher’s exact test was used for categorical
EP
variables. Comparisons were considered statistically significant when P
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values were < 0.05.
RESULTS
A
One hundred and eighteen patients were included in our study. Emergency ERCP was performed within 24 h after hospitalization. The mean age of the patients was 68.7 ± 24.1 years, and 76 cases were male. The clinical characteristics of the 118 patients are listed in Table 1.
Endoscopic observation found CBD stones impacted at the papillary orifice in 53 cases, at the central papilla in 36 cases, and at the roof of the papilla in 29 cases. The success rate of NKPP and CBD cannulation was 100%. The mean operating time was 6.4 ± 4.1 min. The clearance rate of impacted
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stones in emergency ERCP was 94.9% (112/118). The other six cases all had stones at the papillary roof, and after NKPP revealed the orifice of the CBD,
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cannulation was performed first. No further stone extractions were carried
out. The stones in these six cases were cleared by a second ERCP. Three
U
patients underwent pancreatic duct stent drainage for prevention of acute
N
severe pancreatitis.
A
The total complication rate was 4.2% (5/118); two cases with hemorrhage
M
and three with acute pancreatitis. One case of acute pancreatitis occurred in
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Group A. One case of hemorrhage occurred in Group B. One case of hemorrhage and two of acute pancreatitis occurred in Group C. The
EP
complication rate in each group did not differ significantly. The two cases of hemorrhage were cured by endoscopic hemostasis, and the three cases of
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acute pancreatitis were cured conservatively. There was no procedure-related
A
mortality. The outcomes of the three groups are shown in Table 2. The clinical data about the recovery were monitored for 48 h
postoperatively. Compared to preoperative data, postoperative WBC, PCT level, liver function and APACHE II scores improved significantly (Table 3). All patients underwent blood or bile bacterial culture and 87 cases were
positive: Escherichia coli in 66 cases, Staphylococcus epidermidis in 15, Pseudomonas aeruginosa in 37, Bacillus fragilis in 23, Bacillus proteus in nine, and Klebsiella pneumoniae in 17.
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DISCUSSION ACST is a challenge for physicians. Biliary duct obstruction results in
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increased internal pressure and a backflow of bacteria and endotoxins in the CBD, which causes bacterial colonization and severe systemic infection. ACST
U
can develop rapidly into septic shock and multiple organ failure, which are
N
severe complications with high mortality, especially for elderly patients.
A
Surgical biliary duct drainage should be performed as soon as possible
M
[7]. Conventional surgery involves common bile duct exploration, with T tube
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drainage. In elderly patients, especially those with one or more comorbidities, the operation is difficult because of surgical trauma and high risk [8]. In our
EP
study, the mean age of the 118 patients was 68.7 years and 86.4% (102/118) had a history of comorbidity.
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As endoscopic techniques have developed rapidly, endoscopic biliary duct drainage has become the optimal management strategy and has been
A
widely accepted. Impacted CBD stone at the papilla is one factor that makes cannulation difficult for conventional ERCP [3]. Under these conditions, duodenal papillae were swollen with edema. The orifice was reduced in size and was blocked completely, so that the standard cannulation of the CBD was
difficult. And repeated cannulations are a risk factor for post-ERCP pancreatitis [9, 10]. Early NKPP was a reasonable choice for the difficult situation. NKPP is used as a rescue technique for difficult biliary cannulation, although it is
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usually associated with a high risk of complications including hemorrhage, perforation and pancreatitis [11-13]. However, many recent studies have
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reported that the complication rate of precut papillotomy is not significantly different compared to that of conventional papillotomy [14-16]. Kaffes et al
U
[15] reported that 70 cases underwent NKPP with a success rate of 93%, and
N
the rate of complications did not differ from that of conventional papillotomy.
A
They proposed early introduction of precut techniques for difficult biliary
M
cannulation.
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Impacted stones at the papilla resulted in bulging of the sphincter of Oddi and the pancreatic duct orifice was walled off from the anterior wall of
EP
the sphincter. So, it is important for NKPP to choose a suitable starting site and corresponding papillotomy after establishing the location of the impacted
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stones, which could reduce the risk of perforation and post-ERCP pancreatitis as much as possible. ACST with systemic infection usually results in
A
abnormal coagulation, as well as papillary edema, which increase the risk of hemorrhage. Therefore, NKPP should be performed slowly and steadily, layer by layer, so that the incised margin could stop bleeding reliably [17]. In our study, the success rate of NKPP and CBD cannulation was 100%. The total
complication rate was 4.2% (5/118), with two cases of hemorrhage and three of acute pancreatitis, which did not differ significantly from the literature [14-16, 18, 19]. There was no procedure-related mortality. The mean operating time was 6.4 ± 4.1 min. The operating time was
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shorter in Groups A and B compared with Group C. For Group C (stones impacted at the roof of the papilla), NKPP started from the papillary orifice
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and was oriented toward the papillary root, layer by layer. The movement of
the needle-knife sphincterotome should be small, like a pendulum, when near
U
the roof of the papilla because impacted stones cause overextension of the
N
anterior wall of the Oddi’s sphincter, and the papilla retracts after stone
A
removal. It was necessary to preserve the distance between the roof of the
M
papilla and the extent of the papillotomy to avoid irreversible perforation
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resulting from excessive papillotomy. So, when stones were impacted at the roof of the papilla, the NKPP procedure was more complex and had a higher
EP
risk of perforation, although the complication rate of the three groups did not differ significantly.
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For ACST, the endoscopic procedures should be simplified to reduce operating time and complication risk as much as possible [7, 20]. Biliary duct
A
drainage was the main aim and it was not necessary to clear up all the CBD stones during the procedures. After NKPP, most of the impacted stones could be pushed into the duodenal lumen by hyperbaric bile. The clearance rate of impacted stones in emergency ERCP was 94.9% (112/118). The other six cases
all had stones at the papillary roof that were removed by the second ERCP. After successful cannulation, contrast agent should be injected at low pressure and then aspirated out to prevent bacterial backflow and infection. In our study, an ENBD tube was inserted into the CBD along the guide
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wire after successful cannulation. The infected bile was drained from the nasal tube and underwent bacterial culture. The sensitive antibiotic was used.
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The effect of ENBD was not only to drain bile and sustain the papillary orifice, but also to avoid stones or viscous infected bile blocking biliary drainage by
U
antibiotic saline douching [21, 22].
N
Postoperative WBC and PCT level were significantly decreased
A
compared with preoperatively, which indicated that the infection improved
M
gradually. Liver function also improved after NKPP. APACHE II scores were
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widely used to assess the severity and prognosis of patients. Postoperative APACHE II scores significantly decreased from 13.2 ± 7.3 to 7.7 ± 3.2, which
EP
indicated improvement in the patients’ systemic condition. In conclusion, emergency NKPP can be an effective and safe procedure
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for ACST resulting from impacted CBD stones at the duodenal papilla. Precut papillotomy procedure is chosen according to the location of the stones at the
A
papilla. Further prospective randomized controlled studies are still needed.
Conflict of interest statement: no commercial relationships that might pose a conflict of interest in connection with the submitted manuscript need be
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M
A
N
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disclosed.
REFERENCES [1] Mosler P. Diagnosis and management of acute cholangitis. Curr Gastroenterol Rep 2011; 13:166–72.
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[2] Caddy GR, Tham TC. Gallstone disease: Symptoms, diagnosis and endoscopic management of common bile duct stones. Best Pract Res Clin
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Gastroenterol 2006; 20: 1085-101.
[3] Joo KR, Cha JM, Jung SW, et al. Case review of impacted bile duct stone at
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duodenal papilla: detection and endoscopic treatment．Yonsei Med J 2010;
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51: 534-9.
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[4]Freeman ML, Guda NM. ERCP cannulation: a review of reported
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techniques. Gastrointest Endosc 2005; 61:112–25.
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[5] Hao F, Zheng M, Qin M. The Effect of Endoscopic Ultrasonography in Treatment of Distal Inflammatory Biliary Stricture: A Retrospective
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Analysis of 165 Cases. Hepatogastroenterology 2014 Nov-Dec; 61: 2177-80. [6] Freeman ML, Nelson DB, Sherman S, et al. Complications of endoscopic
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biliary sphincterotomy. N Engl J Med 1996; 335:909–18.
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[7] Kimura Y, Takada T, Strasberg SM, et al. TG13 current terminology, etiology, and epidemiology of acute cholangitis and cholecystitis. Journal of Hepato-Biliary-Pancreatic Sciences 2013; 20:8–23. [8]
JOSHI
RM,
SHETTY
TS,
ADHIKARI
DR, Singh
R,
et
Choledocholithiasis: endotherapy versus surgery. Int Surg 2010; 95:95-9.
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[9] Freeman ML, DiSario JA, Nelson DB, et al. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc 2001; 54: 425-34. [10] Bailey AA, Bourke MJ, Kaffes AJ, et al. Needle-knife sphincterotomy:
(with video). Gastrointest Endosc 2010; 71: 266–71.
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Factors predicting its use and the relationship with post-ERCP pancreatitis
complications. Curr Gastroenterol 2001; 3: 147-53.
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[11] Larkin CJ, Huibregtse K. Precut sphincterotomy: indications, pitfalls, and
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[12] Tae Hoon Lee, Byoung Wook Bang, Sang-Heum Park, et al. Precut
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Fistulotomy for Difficult Biliary Cannulation: Is It a Risky Preference in
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Relation to the Experience of an Endoscopist? Dig Dis Sci 2011; 56:
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1896–903.
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[13] Foutch PG. A prospective assessment of results for needle-knife papillotomy and standard endoscopic sphincterotomy. Gastrointest
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Endosc 1995; 41:25–32.
[14] Robison LS, Varadarajulu S, Wilcox CM. Safety and success of precut
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biliary sphincterotomy: Is it linked to experience or expertise? World J Gastroenterol 2007; 13: 2183–6.
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[15] Kaffes AJ, Sriram PV, Rao GV, et al. Early institution of precutting for difficult biliary cannulation: a prospective study comparing conventional vs. a modified technique. Gastrointest Endosc 2005; 62: 669-74. [16] Lee TH, Hwang SO, Choi HJ, et al. Sequential algorithm analysis to
facilitate selective biliary access for difficult biliary cannulation in ERCP: a prospective clinical study. BMC Gastroenterology 2014; 14(1): 1-8. [17] Artifon EL, Da SE, Aparicio D, et al. Management of common bile duct stones in cirrhotic patients with coagulopathy: a comparison of
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supra-papillary puncture and standard cannulation technique. Dig Dis Sci 2011; 56: 1904-11.
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[18] Kasmin FE, Cohen D, Batra S, et al. Needle-knife sphincterotomy in a tertiary referral center: efficacy and complications. Gastrointest Endosc
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1996; 44: 48-53.
safe
and
effective
technique
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a
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[19] Katsinelos P, Mimidis K, Paroutoglou G, et al. Needle-knife papillotomy: in
experienced
hands.
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Hepatogastroenterology 2004; 51: 349-52.
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[20] Miura F, Takada T, Strasberg SM, et al. TG13 flowchart for the management of acute cholangitis and cholecystitis. J Hepatobiliary
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Pancreat Sci 2013; 20: 47-54.
[21] Lee DW, Chan AC, Lam YH, et al. Biliary decompression by nasobiliary
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catheter or biliary stent in acute suppurative cholangitis: a prospective randomized trial. Gastrointest Endosc 2002; 56: 361-5.
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[22] Park SY, Park CH, Cho SB, et al. The safety and effectiveness of endoscopic biliary decompression by plastic stent placement in acute suppurative cholangitis compared with nasobiliary drainage. Gastrointest Endosc 2008 Dec; 68: 1076-80.
76/42
Age (yr) (mean ± SD)
68.7 ± 24.1
Charcot triad
118
Reynolds and Dargan pentad
53 (44.9%)
Gallstone pancreatitis
27 (22.9%)
Cholecystolithiasis
75 (63.6%)
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Gender, M/F
N
Comorbidity history
M
A
Coronary heart disease Hypertension
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Table 1 Clinical characteristics of 118 patients
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Chronic obstructive pulmonary disease
46 52 17 44
Cerebral infarction
31
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Diabetes mellitus
13
Hepatic cirrhosis
11
Renal insufficiency
5
A
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Cerebral hemorrhage
The median duration of ACST (h)
15.7 (range, 3–48)
ACST, acute cholangitis of severe type; F, female; M, male. Table 2 Outcomes of NKPP for each group Group A
Group B
Group C
P value
Operating
53
36
29
3.4±2.8
4.6±3.7
8.2±5.5
P1 = 0.085 P2 = 0.0025
time (min)
P3 < 0.0001
Success of
100%
100%
100%
100%
100%
79.3%
Disimpaction rate of
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cannulation
P2 < 0.0001
(23/29)
P3 < 0.0001
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impacted stones Complications
1.9%
Acute
(1/53)
P1 = 0.4045
(1/36)
N
P2 = 1.0
0
(1/29)
P3 = 0.3537
6.9%
P1 = 1.0
(2/29)
P2 = 0.1952
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pancreatitis
3.4%
A
Hemorrhage
2.8%
M
0
U
(%)
P3 = 0.2842
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P1: comparison between Groups A and B; P2: comparison between Groups B and C; P3: comparison between Groups A and C.
A
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Table 3 Comparison of clinical data before and after NKPP
WBC
Before
0.05)
P
11.2 ± 5.1
< 0.0001
4.32 ± 3.11
< 0.0001
NKPP 15.8 ± 4.3
PCT (ng/mL, normal range <
48 h after NKPP
9.38 ± 4.25
TBIL (μmol/L) (normal range,
54.6 ± 22.7
< 0.0001
35.7 ± 18.4
< 0.0001
78.2 ± 35.1
< 0.0001
83.4 ± 37.7
5.1–20.4) DBIL (μmol/L ) (normal range,
61.1 ± 21.8
ALT (U/L) 128.9 ± 46.7
5–40) APACHE II scores
7.7 ± 3.2
13.2 ± 7.3
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(normal range,
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1.7–6.8)
< 0.0001
A
CC
EP
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M
A
N
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ALT, alanine aminotransferase; APACHE II, acute physiology and chronic health evaluation II; DBIL, direct bilirubin; PCT, procalcitonin; TBIL, total bilirubin; WBC, white blood cell count.