Keywords
Stones - Cholangioscopy
Introduction
Acute cholecystitis is a common abdominal emergency caused by inflammation of the
cystic duct mainly due to obstruction, bacterial invasion, and/or infection [1]. Open cholecystectomy + common bile duct lithotomy was the preferred treatment for
acute cholecystitis secondary to choledocholithiasis for decades [2]. More recently, this was largely replaced by minimally invasive laparoscopic cholecystectomy
+ common bile duct lithotomy and endoscopic retrograde cholangiopancreatography (ERCP)
+ laparoscopic cholecystectomy. This combined approach has become the standard of
care wherever the resources and expertise are available [3]. However, emergency cholecystectomy is complicated by a both a high complication
rate (55%–66%) and mortality rate of between 14% and 30% [4]. Percutaneous transhepatic gallbladder drainage (PTGD) was introduced to reduce
the risk of surgery and associated complications. Typically, emergent minimally invasive
drainage of bile is used to control gallbladder inflammation followed by ERCP to manage
common bile duct stones followed by elective cholecystectomy.
EyeMax (Nanwei Medical Technology Co., Ltd., Nanjing, China) is a single-operator
cholangioscopy system (SOC). It is a novel fiber optic direct vision system designed
for the management of bile duct stones and for the evaluation of biliary stricture
[5]. The EyeMax system provides both imaging for endoscopic procedures of the pancreatobiliary
system as well as working channels for other diagnostic and therapeutic accessories.
Two EyeMax systems are currently available, the CDS11001 model with an instrument
channel diameter ≥ 1.8 mm and Nnewi effective working length of 2200 ± 50 mm. The
maximum insertion outer diameter ≤ 4.2mm and the maximum field of view angle is 120°±18°.
The other model, which was used in this study ( model CDS22001), has an instrument
channel diameter of ≥ 1.0 mm and an effective working length of 2200±50 mm. The maximum
outer diameter of the maximum part is ≤3.2 mm with a maximum field of view angle of
120° ± 18°. The CDS2201 model was used because it can easily pass through the spiral
structure of the gallbladder neck.
Herein, we describe the use of the SOC system to treat acute cholecystitis secondary
to choledocholithiasis. The instrument allowed direct vision of the gallbladder and
biliary ducts, directed irrigation, as well as lithotripsy, if needed. The purpose
of this study was to investigate the safety and efficacy of ERCP+SOC system for the
treatment of acute cholecystitis secondary to choledocholithiasis.
Patients and methods
Study design and protocol
Twenty-five patients with acute cholecystitis secondary to choledocholithiasis admitted
to our hospital between January 2022 and June 2023 were studied. The inclusion criteria
included: 1) patients with acute cholecystitis secondary to choledocholithiasis diagnosed
by abdominal computed tomography (CT) or magnetic resonance cholangiopancreatography
(MRCP); 2) patients with no relevant drug or surgical treatment before the procedure;
3) patients who voluntarily signed informed consent; and 4) patients with no history
of previous ERCP treatment, and no disease or drug history affecting coagulation function.
The exclusion criteria were: 1) patients with other biliary diseases, such as intrahepatic
bile duct stones, bile duct stenosis, etc; 2) patients with upper gastrointestinal
reconstruction; 3) patients with failure of multiple organs such as the heart, brain,
and lungs; and 4) patients with known or suspected duodenal papilla, common bile duct,
or gallbladder tumors.
Description of the technique
The procedure was done under general anesthesia with patients in the left lateral
position. Endoscopic ultrasonography was performed to identify the location, number
and size of common bile duct stones, gallbladder wall thickness, and the presence
of gallbladder stones. The duodenoscope was introduced and advanced to the descending
segment of the duodenum for intubation of the papilla. After intubation, incision
and dilatation of the papilla was performed based on the size of the stone. Stone
extraction was performed using a balloon or biliary extractor. The SOC instrument
was then introduced via the endoscopy channel to identify the opening of the cystic
duct. The guidewire was passed through the cystic duct into the lumen of the gallbladder,
which was irrigated with a metronidazole-containing solution. Irrigation of the gallbladder,
sedimentary stones, and septic bile was performed until the fluid returns were clear
([Fig. 1] and [Fig. 2]). Smaller stones were removed via SOC under direct vision. For larger stones, lithotripsy
was performed followed by irrigation to clear the debris. Finally, a pigtail-type
nasobiliary tube was placed under the guidance of the guidewire for drainage ([Video 1]).
Fig. 1
a SOC view of the common bile duct, which shows slightly hyperemic and edematous mucosa
at the end of the common bile duct. b SOC imaging of the opening of the cystic duct, which shows obviously hyperemic and
edematous mucosa. c Large amount of pus and bile mud attached to the gallbladder wall is seen after entering
into the gallbladder under guidewire guidance. d The yellow soft texture stones in the gallbladder cavity can be seen before the lavage.
e Fluid in the gallbladder cavity is suctioned by negative pressure, and the structure
of the gallbladder wall and the shape of the blood vessels are clearly observed. f X-ray image of indwelling nasobiliary drainage in the gallbladder cavity and indwelling
pigtail-type plastic stent in the bile duct.
Fig. 2
a The wall of the common bile duct is smooth and there is no pus attached after the
procedure (complete irrigation). b The upper left opening is the opening of the cystic duct without any hyperemia, edema,
no pus, the lower right opening is the common hepatic canal. c The cervical canal of the gallbladder and the Heister valve are clearly visible.
d The gallbladder wall is clear, and there is no pus and stone residue compared with
the preoperative view. e The superficial vessels of the mucosa at the base of the gallbladder are multi-trunk
branches. f The superficial blood vessels of the mucosa of the gallbladder body after drainage
are clearly visible and show trunk + network branches.
The description of SOC-assisted drainage of the gallbladder.Video 1
Definitions
Procedure technical success was defined as successful entry into the gallbladder and
placement of double pigtail stent in the gallbladder via SOC. Clinical success was
defined as patient relief from symptoms (fever, abdominal pain) after the treatment
with SOC, without referral to the Surgery Department for cholecystectomy.
Statistical analysis
Statistical analyses were performed using IBM SPSS Statistics 25.0 (Statistical Package
for the Social Sciences, Inc, Chicago, Illinois, United States). Chi - square test
or the Fisher’s exact test was used for comparison of categorical data. P < 0.05 was statistically significant.
Results
Twenty-five patients with acute cholecystitis secondary to choledocholithiasis were
included in this study. The baseline characteristics of all the included patients
are summarized in [Table 1]. The procedure technical success rate was 92% (23/25) and the clinical success rate
was 96% (24/25). The mean procedure time was 36.6 ± 10 minutes (standard deviation).
All the patients had a significant decrease in C-reactive protein (CRP) after the
procedure. The average postoperative hospitalization was 2 ± 0.8 days.
Table 1 Baseline characteristics of patients included in this study.
|
Characteristics
|
ERCP+SOC patients (n=25)
|
|
ERCP, endoscopic retrograde cholangiopancreatography; SOC, standard of care; SD, standard
deviation; IQR, interquartile range; WBC, white blood cell; CRP, C-reactive protein;
CT, computed tomography; EUS, endoscopic ultrasound.
|
|
Age (year), (mean ± SD)
|
73.68 ± 13.82
|
|
Sex, (male/female)
|
10/13
|
|
Symptoms (d), median (IQR)
|
3 (1–7)
|
|
WBC (x109/L), median (IQR)
|
10.40 (8.80–13.60)
|
|
CRP (mg/L), median (IQR)
|
72.00 (34.00–85.60)
|
|
CT/EUS n (%)
|
25 (100%)
|
|
Temperature ≥ 38°C, n(%)
|
9 (36.00%)
|
Technical failure occurred in two patients because SOC failed to traverse the cystic
duct, which was, however, irrigated without entering the gallbladder. Currently, attempts
to traverse the cystic duct are gentle to prevent possible cystic duct laceration
or perforation. However, a cystic duct balloon for dilation is under development.
If successful, it may overcome the bottleneck of the cystic duct and allow smooth
entry of SOC. One of the patients did not achieve clinical success with SOC and subsequently
underwent PTGD treatment with symptom relief.
No adverse events such as bleeding, perforation, or bile leakage were noted in any
patient. There were three cases of mild cholangitis, and five cases of mild pancreatitis
after the procedure, which are also conventional complications of ERCP. After the
acute event improved, we placed an indwelling double pigtail stent into the gallbladder
for drainage. It is generally recommended that it be drained for 3 months and up to
6 months. After 3 months, telephone follow-up of our patient was performed and clinical
symptoms were observed and discussed. Ultrasound was also performed to observe the
gallbladder and bile ducts, and the double pigtail stent was removed by endoscopic
examination. (That typically is done at between 3 to 6 months, depending on a patient’s
condition.) In our patient, no recurrence of cholecystitis symptoms occurred during
2 to 18 months (12.8 ± 3.9) of follow-up.
Discussion
The treatment of common bile duct stones has gradually transitioned from traditional
open to minimally invasive laparoscopic lithotomy to ERCP [6]. With the rapid development of ultrasound interventional technology, PTGD is becoming
a safe and effective treatment modality for patients with acute cholecystitis [7]. However, surgical intervention is still required for the treatment of common bile
duct stones. The current clinical success rate for PTGD is between 80% and 96%, and
the complication rate after PTGD ranges between 4% and 17% [4]
[5]
[6]
[7]
[8]. The main complications after PTGD include biliary bleeding, pneumothorax, biliary
leakage, intra-abdominal abscess, intestinal perforation, drainage tube detachment,
and duct blockage [8]. In addition, the routine drainage tube placement time after PTGD surgery is about
4 weeks, and the puncture point remains prone to infection, requiring regular dressing
changes, which affects the quality of a patient’s life.
A recent study by Storm et al. suggested ERCP stenting of the gallbladder as the first-line
treatment for patients with acute cholecystitis who are not suitable candidates for
cholecystectomy, with a technical success rate of 96% and a clinical success rate
of 100% [9]. However, a traditional ERCP procedure requires long exposure to x-ray. The novel
SOC system allows direct observation of the biliary tract through a digital visualization
system without x-ray guidance, making it especially useful for pregnant women and
for the specific populations who should not be exposed to x-rays, such as couples
who are planning to conceive in near future.
At present, cholangioscopy has been widely used in the management of biliary diseases.
In this study, we introduce the use of a novel SOC system for acute cholecystitis,
which includes irrigation of the gallbladder under direct visualization. We also explored
the effectiveness and safety of the novel SOC system along with ERCP for the treatment
of acute cholecystitis secondary to choledocholithiasis. This technique is designed
for patients with acute cholecystitis secondary to common bile duct stones because
it can simultaneously solve the problem of the common bile duct stones and acute cholecystitis.
There was an immediate decrease in postoperative CRP and a significant recovery of
inflammatory indexes after the procedure. The traditional treatment option for acute
cholecystitis secondary to common bile duct stones was surgery, in which the gallbladder
was removed and a common bile ductotomy was performed to remove the stones. EyeMax
cholangioscopy is a minimally invasive procedure to treat acute cholecystitis under
direct visualization. It not only quickly relieved the symptoms of acute cholecystitis,
but also allowed examination of the inner wall of the gallbladder. Therefore, the
EyeMax cholangioscope has both diagnostic and therapeutic value similar to the spyglass
cholangioscope used in endoscopic retrograde appendicitis therapy for the management
of acute appendicitis especially caused by obstruction [10].
However, technical difficulties in entering to the gallbladder through the spiral
structure of the cystic duct remain and add to the overall procedure time. However,
with further advances in technology and experience, these technical challenges are
expected to be overcome or reduced.
Conclusions
In conclusion, ERCP+SOC may provide a feasible, safe, and effective alternative treatment
for acute cholecystitis secondary to choledocholithiasis. ERCP + SOC was able to simultaneously
resolve both biliary tract and gallbladder problems via natural orifice endoscopy.
Its advantages include no skin wound, reduced postoperative pain, quick recovery,
limited or no exposure to x-rays, and a short hospital stay.
