Twenty-six patients (8 male and 18 Female) received 28 fully covered self-expanding metal stents. The mean age of the patients was 58.5 years. In patients with pancreatic carcinoma, the procedure was performed within 2 d after admission if abdominal ultrasound or computed tomography showed biliary obstruction and/or laboratory tests indicated cholestasis. ERC and sphincterotomy and stent placement were successful at first attempt in all cases of pancreatic carcinoma. In the other six patients who received stents due to benign indications sphincterotomy had already been performed previously, and stent placement was technically feasible in all patients at first attempt. Drainage was achieved as monitored by a rapid decrease or normalization of bilirubin. In two patients, the stent was inserted because of severe bleeding following endoscopic sphincterotomy. This procedure led to an immediate pressure onto the bleeding area and made control of bleeding by injection of saline/epinephrine easy and safe.

No re-stenosis occurred during a follow-up period of 6 mo in two patients with distal bile duct stenosis due to chronic pancreatitis. The third patient underwent surgery as malignancy could not be excluded.

Our report shows that biliary drainage can be achieved using fully covered self-expanding metal stents regardless of the underlying disease, be it benign or malignant. Recent and our data suggest that CSEMS were not associated with a higher rate of complication compared to uncovered self-expanding metal stents or plastic stents. In contrast to the latter a much lower rate of occlusion and subsequent cholangitis was observed. This is in accordance with another recent report, in which the authors recommend fully covered self-expanding stents as the initial intervention for biliary obstruction even if the surgical respectability status is uncertain[ ¹]. The internal diameter of 8 mm to 10 mm of these stents ascertains sufficient bile flow, if bile is very viscous because of previous biliary obstruction. We chose the length of the stent as short as possible to avoid any alteration of the proximal common bile duct. If surgery for the underlying disease was possible, no biliary leaks or complications of the biliary anastomosis were observed. In the patients in whom resection was not intended or could not be performed because of widespread or metastatic disease, stents remained in place on follow-up.

CSEMS intended initially to palliate malignant biliary obstruction, have been used recently in management of various benign biliary conditions and iatrogenic complications, as in post-sphincterotomy bleeding. In a case series including five patients, the use of CSEMS was effective to achieve hemostasis in all patients. However, migration of the stents occurred in two patients[ ²]. In the two patients described in our paper temporary placement of fully CSEMS was effective in controlling severe bleeding following endoscopic sphincterotomy, which could not be managed by other means. No stent dislocation occurred, as we removed the stents 2 wk after implantation. New development, like anchoring flap at the proximal end of the stent may be an option as well to prevent stent migration[ ³].

So far, only plastic stents could be removed safely endoscopically if necessary. The disadvantage of these stents, however, is the small internal diameter which predisposes to occlusion by biliary sludge. On the other hand, self-expanding metal stents resulted in efficient drainage of biliary obstruction with good bile flow due to the large diameter in contrast to plastic stents. The big drawback of self-expanding metal stents, nevertheless, was that they could not be extracted easily, if at all. With the availability of fully covered self-expanding stents this short coming has been overcome.

In a multicenter study, including 37 patients removal attempts of the CSEMS were successful in all cases[ ⁴]. The endoscopic feasibility and safety of stent removal were also documented by other authors[ ⁵]. In our series endoscopic removal of the stents was feasible and safe in all patients, in whom stent explanation was desired.

We observed cholecystitis in two patients. In both patients, the outlet of the cystic duct into the common bile duct was blocked by the stent. Although the numbers are small, we suggest that this complication should be avoided by using a stent length with the upper end distal to the cystic duct outlet. In one study, this complication occurred in 20% of cases if the CSEMS covered the cystic duct. A gallbladder stent (seven French transpapillary pigtail gallbladder stent) was effective in reducing the risk of developing cholecystitis after CSEMS placement[ ⁶].