Intraductal placement of a fully covered metal stent with a long string for distal malignant biliary obstruction without endoscopic sphincterotomy: Prospective multi‐center feasibility study

Abstract

Background Stent migration and sludge clogging are characteristic problems in biliary covered self‐expandable metal stent (SEMS) placement. Intraductal placement without endoscopic sphincterotomy (ES) may help reduce their occurrence. We examined the feasibility of intraductal placement of a covered SEMS with a long string without ES in patients with unresectable distal malignant biliary obstruction (MBO). Methods This was a prospective multi‐center observational study. Forty patients with distal MBO were enrolled between July 2016 and August 2018. We evaluated recurrent biliary obstruction (RBO), adverse events other than RBO, and reintervention associated with intraductal placement without ES. Results Both technical and functional success rates were 100% (40/40). The rate of adverse events other than RBO was 5% (2/40). The RBO rate was 33% (13/40), and the median time to RBO was 339 days. RBO was mainly caused by overgrowth on the papillary side, occurring in six patients; all such patients had pancreatic cancer and a distance between the papilla and the stricture of ≤20 mm. Other causes were overgrowth at the hepatic side in two patients and sludge in five patients. No instances of stent migration occurred. Success rates of endoscopic transpapillary reintervention and stent removal using the string were 92% (12/13) and 77% (10/13), respectively. Conclusions Intraductal placement without ES using a long‐stringed covered SEMS is a promising option for distal MBO. Since overgrowth on the papillary side is frequent, the procedure should be avoided in patients with short distances between the stricture and the papilla. (Clinical Trial Registry: UMIN000023370)

Feasibility of biliary stenting to distal malignant biliary obstruction using a novel designed metal stent with duckbill‐shaped anti‐reflux valve

“…For this purpose, biliary stenting above the papilla, namely, intraductal stenting, has been developed. [20][21][22] For successful intraductal stenting, biliary obstruction must be apart from the papilla of Vater. The efficacy of intraductal stenting has been reported particularly for hilar MBO.…”

“…The prevention of duodenobiliary reflux is a major concern in the management of biliary stenting. For this purpose, biliary stenting above the papilla, namely, intraductal stenting, has been developed 20–22 . For successful intraductal stenting, biliary obstruction must be apart from the papilla of Vater.…”

Antireflux metal stent for biliary obstruction: Any benefits?

“…2). 20,34–37 Several series suggest that intraductal biliary stent placement without sphincterotomy may reduce the risk of stent dysfunction due to the duodenobiliary reflux and thereby, secure long patency 38,39 . However, in the setting of distal MBO, the distal stent end should often be positioned in the duodenal lumen to fully cover the stricture.…”

“…20,[34][35][36][37] Several series suggest that intraductal biliary stent placement without sphincterotomy may reduce the risk of stent dysfunction due to the duodenobiliary reflux and thereby, secure long patency. 38,39 However, in the setting of distal MBO, the distal stent end should often be positioned in the duodenal lumen to fully cover the stricture. Therefore, investigations of antireflux mechanisms for biliary SEMSs may have substantial impact on quality of life among patients with nonresectable distal MBO.…”

Ways to improve stenting in unresectable malignant distal biliary obstruction: Stent design, intraductal placement, and protective role of an intact papilla?

“…Despite multiple efforts to prolong stent patency and improve the safety, there is still no ideal CSEMS designed with perfect anti‐migration and anti‐duodenobiliary reflux properties, and with reduced risk for pancreatic duct obstruction. In this issue of DEN, Inoue et al , 9 reported a trial in which they placed a CSEMS above the papilla without endoscopic sphincterotomy (ES), with the hypothesis that an intact papilla would prevent migration and duodenobiliary reflux and that an intraductal stent would not block the pancreatic orifice. ES before SEMS placement may reduce obstruction of the pancreatic duct; however, ES was ineffective to prevent pancreatitis in UMDBO from pancreatic cancer, because the main pancreatic duct is obstructed and the pancreatic parenchyma is atrophied in many pancreatic cancer patients.…”