Malignant hilar strictures (MHS), type ≥2 according to the Bismuth-Corlette classification of cancers of the human biliary tract [
From April 2009 to August 2012, we prospectively collected data on patients treated with Y-shaped SEMS placement for advanced malignant hilar carcinoma. All patients were diagnosed as having MHS by computer-assisted tomography or magnetic resonance imaging. Histologic and cytologic confirmation of malignancy was made for all the patients. Indication for stent placement was an increase in bilirubin levels with evidence of intrahepatic bile ducts dilatation. Patients were treated within 48 hours from the admittance. All patients were not treated previously. Data were collected in an electronic database and subsequently exported to the statistical software for final analysis.
All patients were hospitalized and complete full blood count, chemistry, and coagulation parameters were obtained. Stent placement was discussed with the surgeon and both tumor characteristics/location and overall clinical condition were taken into account. An informed consent was always obtained before the procedure. All endoscopic procedures were performed with a therapeutic channel video duodenoscope with the patient under deep sedation with propofol. SEMS (Niti-S Biliary Y stent, Taewoong, Seoul, Republic of Korea) were placed during ERCP and according to manufacturer’s instructions, by an experienced endoscopist. The length and the size of SEMS were the same in all treated patients. After common bile duct cannulation, cholangiography, and subsequent sphincterotomy, a guidewire was placed, under fluoroscopic guidance, across the left hepatic duct. Evaluation of the severity of the stricture was made with contrast injection. The first uncovered SEMS, with a wide-open central mesh were placed across the hilar stricture. If needed, balloon dilation was performed before stent placement. The guidewire was then withdrawn slowly and, with the aid of a 5.5 French catheter, inserted under fluoroscopic guidance into the wide-open central mesh of the first stent, identified by radiopaque markers. The second uncovered SEMS were placed through the central crossed mesh of the primary stent (Y-shaped configuration) to drain the right hepatic duct (Figure
(a) Niti-S stent assembled (Y-shaped configuration). (b-c) Images from a patient with hilar cholangiocarcinoma before (b) and after (c) stent placement.
All patients, data on technical success, clinical success, and complications were collected. All patients were followed up in the outpatient clinic or by phone until death.
Technical success was defined as successful bilateral SEMS placement across the stricture, confirmed by radiological markers at fluoroscopy, with outflow of contrast medium and/or bile through the stents. Clinical success was defined as reduction of bilirubin levels of at least 75% of the pretreatment value within the first month. Complications were defined as any event related to SEMS placement (included occlusion). Complications were defined as early if complications occurred within 30 days and late if occurring after 30 days. We also considered any bleeding due to endoscopic sphincterotomy, according to the Cotton criteria [
Data were analyzed using the software package SPSS 15 (SPSS Inc., Chicago, IL, USA). Continuous variables were summarized as mean (±standard deviation [SD]) or median (range) according to their distribution. Categorical variables were summarized as frequency and percentage.
We enrolled 20 patients, 9 males (45%) and 11 female (55%), with a mean age of
One patient (5%) experienced cholangitis as an early complication, which resolved with medical therapy. Among the late complications, 2 patients (10%) were treated with plastic stent placement (10 French) through the metallic stent because of SEMS ingrowths at 3 and 10 months, respectively. The “Y-shape” did not cause trouble to insert the plastic stents but the stents were placed on a wire guide previously inserted in the occluded SEMS. There was no procedure-related mortality.
Endoscopic insertion of plastic endoprosthesis has become widespread in patients with malignant proximal biliary obstruction, limiting surgical intervention to a minority of selected patients in whom the tumor seems to be resectable [
The diffusion of SEMS has modified the palliative approach in unresectable patients. A recent randomized controlled trial [
Drainage of obstructed ductal systems has been strongly advocated as allowing for a significant reduction in morbidity and mortality because of better bile flow [
In order to improve the feasibility of bilateral SEMS placement, and to avoid the parallel placement of two stents, Silverman and Slivka [
Since then, several studies have reported similar experiences in larger number of patients treated with the stent-in-stent technique [
Studies on bilateral self expandable metallic stent placement in malignant hilar strictures.
Study | Number of patients | Type of SEMS | Technical success | Functional success | Tumor ingrowth |
Complications |
SEMS patency |
---|---|---|---|---|---|---|---|
Lee et al. (2007) [ |
10 | Niti-S | 80% | 100% | 25% | 0%/0% | 217 days |
Park et al. (2009) [ |
35 | Bonastent | 94.3% | 100% | 0% | 0%/0% | 150 days |
Kim et al. (2009) [ |
34 | Niti-S | 85.3% | 100% | 31% | 10.3%/37.9% | 186 days |
Chahal and Baron (2010) [ |
21 | Flexxus | 100% | — | 33.3% | — | 189 days |
Kogure et al. (2011) [ |
5 | Niti-S LGD* | 100% | — | 40% | 20%/— | 202 days |
Kanno et al. (2011) [ |
20 | Niti-S | 100% | 95% | 30% | 5%/0% | 250 days |
Hwang et al. (2011) [ |
30 | Niti-S | 86.7% | 100% | 38.5% | 10%/0% | 176 days |
Naitoh et al. (2012) [ |
24 | Niti-S | 100% | 100% | 42% | 4%/8% | 104 days |
Kim et al. (2013) [ |
66 | Niti-S | 87.9% | 100% | 34.2% | 12.1%/55.2% | 152 days |
Current study | 20 | Niti-S | 100% | 100% | 10% | 5%/10% | 210 days |
An interesting historical control study compared 20 patients with unresectable malignant hilar biliary obstruction who had undergone endoscopic bilateral Y-configured biliary drainage with SEMS placement to 37 patients who had undergone bilateral drainage with plastic stents (control group) [
A recent large retrospective study by Kim et al. [
Although, as reported above, Y-shaped SEMS are effective and safe in MHS treatment, some possible problems should be discussed: (1) insufficient opening of the central portion of the first stent which can be solved with balloon dilation, (2) inaccurate release of the central open mesh at the hilar bifurcation which can be improved by closing and repositioning the stent, and (3) stent occlusion which can be treated with balloon extraction (in case of sludge or stones), with biliary drainage through percutaneous transhepatic cholangiography or with new plastic or metallic stent placement, or.
In our study, we had a technical and clinical success rate of 100% using 2 nitinol metallic stents placed with the stent-in-stent technique to obtain the characteristic Y-shaped configuration. A significant biliary drainage was achieved also in all patients with Bismuth IV. The rate of observed complications was low, and this data is in agreement with data from a recent review by Kogure et al. [
In conclusion, endoscopic Y-shaped bilateral stent-in-stent SEMS placement is safe and effective for the palliation of unresectable MHS. This is because the technique more closely resembles the physiological bilateral drainage state than does unilateral drainage. These results should be confirmed by larger prospective series and randomized controlled trials so this technique might gain consensus and become a standard of care.
The authors declare that there is no conflict of interests regarding the publication of this paper.
R. Di Mitri and F. Mocciaro are responsible for conception and drafting the paper; F. Mocciaro performed the statistical analysis.