Patients
Form Jan 2017 to Dec 2018, patients received the EUS transluminal cholecystolithotom
(assisted by guidewire or retrievable puncture anchor) in Shengjing Hospital was reviewed.
The including criteria: 1. patients with gallstones and recurrent cholecystitis 2.
Patients refused the cholecystectomy 3. The gallbladder still has the satisfied function.
Exclusion criteria were 1. gallbladder atrophy. 2. coagulopathy and other sever comorbidity.
The protocol to perform retrospective revision of the cases was approved by the Medical
Ethics Committees. All patients gave their informed consent before the use the procedure.
Main coutcome measurement
The main coutcome measures for the EUS-GBD procedure were techniques success, clinical
effectiveness, and adverse events, which were also compared between guided assisted
group and retrievable anchor assisted group. The main outcome measures for the tansmural
cholecystoscopic therapy were the strent indwelling time, clinical success and adverse
events.
The study device
The device used in in this study is a through the scope LAMS with an electrocautery
deliver system (12mm/25mm, 16 mm/35 mm; Micro-Tech/Nan Jing Co, Ltd). The stent is with wide flanges on both ends that provide anchoring within the gallbladder.
The stent is delivered through a 9F-10.5F catheter. In some patients, the retrievable
puncture anchor (Figure 1) (Vedkang Inc., Changzhou, China) was applied to anchor the GB during the ECE-LAMS
puncturing.
The procedure
There are two parts of the treatment for gallbladder stone, which are EUS-guided GBD
at the first time and followed with cholecystolithotomy or polypectomy when the fistula
between the duodenal(stomach) and the GB formed. All the patients were under general
anesthesia and in the lie-down position during operation. After the cholecystolithotomy
procedure, the patients were followed the protocol of Minimally invasive endoscopic
gallbladder preserved cholecystolithotomy guideline in China (2015) and were suggested
periodical US follow-up and regular Ursodeoxycholic acid oral intake.
Gallbladder puncture with needle
A longitudinal echoendoscope (Pentax EG-3870-UT) with a working channel of 3.8 mm was introduced into the duodenal
cavity to scan for the gall bladder and mark the puncture point. The contact zone
(i.e., the region of the duodenal wall representing the shortest distance with gall
bladder walls) was identified. Color Doppler was then used to identify interposing
vessels in order to avoid them during puncture. An EchoTip Ultra endoscopic ultrasound needle (19-gauge, Boston Scientific Corp, Marlborough, Mass, USA) was introduced via the
working channel of the echoendoscope, and the gallbladder was punctured under EUS
guidance. A sample was aspirated to confirm that the punctured structure was gallbladder.
The GB juice was amptied and refilled with saline and the contrast agent for cholecystography.
Guidewire guided stent deployment group
After the needle puncture, several loops of a guidewire (0.035 inch/480 mm; Boston
Scientific, Bloomington, Ind, USA) were inserted into the gallbladder, then the needle
was removed. Under EUS and fluoroscope guidance, the stent was slowly deployed. When
the distal end of the stent contact with the duodenal wall, start the electrocautery
and gently push the stent through the duodenal wall and then gallbladder wall.
Under the fluoroscope surveillance release the stent until the distal flanges was
completely open. Gentle traction was applied to pull the gallbladder wall close to
the gastric wall. Then, under endoscopic surveillance, the remainder of the stent
was deployed (or just release the remainder stent within the endoscope). EUS was used
to confirm the position of the stent and rule out leakage.
Anchor assisted stent deployment group
After the needle puncture, the retrievable anchor is then passed along the needle
into the GB and engaged to anchor the GB. After needle withdrawal, the GB is pulled with the anchor
(Figure 2) when the GB is punctured and drained using ECE-LAMS. After the procedure, the retrieval
cord is pulled with a pair of forceps, so the direction of the anchor is changed and
it can be easily removed (Figure 3).
Per-oral transgastric cholecystoscopic therapy (cholecystolithotomy or cholecyst polyps’ resection)
When the fistula between the GI tract and the GB has formed after the cholecystostomy
with ECE-LAMS, per-oral cholecystoscopy could be performed.
CT or X-ray is used to determine that the stent remained in place. The endoscope is
advanced into the GB via the fistula formed by the stent. A stone basket is inserted
into the gallbladder to retrieve the stones. The basket is withdrawn from the gallbladder,
and the stones are discharged into the GI tract. After several deployments of the
basket to remove stones, an endoscope is introduced into the gallbladder to check
for remaining stones. For the polypus resection, a snare or APC can be used. The stent
could be removed after the procedure or before the stone removing (Figure 4). The normal diet should be resumed 48 hours after the stent removed.
Data analysis
Statistical analyses were carried out with SPSS version 23.0 (SPSS Inc., Chicago,
Ill,USA). Frequencies, percentages, means (±standard deviation) and medians (range)
were used, as appropriate, for descriptive analysis. For categorical variables comparisons
between groups were performed with the Fisher exact test(small sample less than 40).
Continuous variables with normal distribution were analyzed with the Student t test,
whereas for those with abnormal distribution analysis was performed with the Mann-Whitney
U test. All statistical testing was 2-sided.