partially covered metal stents efficacy in biliary drainage of malignant extra-hepatic biliary obstruction

Conditions: Biliary Obstruction

Summary: malignant obstructions of the bile duct are not rare. the most common and accepted method for biliary drainage is endoscopic stent placement. there are three types of metal stents: fully covered (fc), partially covered (pc) and uncovered (u). pc-sems have been recently introduced and compared to fc-sems they seem to have a lower risk of migration, although data in the literature are discordant. therefore the investigators will randomize the participants with biliary obstruction in 2 groups according to the type of stent used: pc-sems or u-sems. after metallic biliary stent insertion, enrolled patients will be followed for 12 months.

malignant obstructions of the bile duct are generally caused by: adenocarcinoma of the vater ampulla, pancreas head cancer, cholangiocarcinoma and external compression secondary to lymph node (ln) metastasis. the management of jaundice and cholangitis, as a result of bile stenosis, is crucial in this group of patients. the most common and accepted method for biliary drainage is endoscopic stent placement with plastic stents or self-expandable metal stents (sems). in recent times, the use of sems has become more common as it provides longer times of patency and a reduced risk of adverse events such as cholangitic episodes. there are three types of metal stents: fully covered (fc), partially covered (pc) and uncovered (u). pc-sems have been recently introduced and compared to fc-sems they seem to have a lower risk of migration, however different randomized and non-randomized studies have compared the outcome of u-sems vs fc-sems with between uncovered and covered stents have produced different results regarding the cumulative patency of stents and endoscopic re-intervention rates. to date, there are few and discordant prospective data on the outcomes of pc-sems use in malignant biliary obstructions. therefore, the investigators will randomize the participants with biliary obstruction in 2 groups according to the type of stent used: pc-sems or u-sems (t0 timing). then the participants will be followed for total period of 12 months. 2 different timings of follow-up will be considered: - t1: it will start after stent insertion. the biliary drainage will be considered effective, according to the european guidelines, when the bilirubin values will be \< or = 2 mg/dl for a period of at least 6 weeks if the initial bilirubin values were higher than 10 mg/dl or 3 weeks if at the beginning were lower than 10 mg/dl; after this first phase, all the enrolled patients will be divided in 2 groups according to their "fitness" for chemiotherapy: fit and unfit group. fit group: blood test (including total bilirubin, gamma-gt) will be done for follow-up study once every three months. unfit group: blood test (including total bilirubin, gamma-gt) will be done for follow-up study after 3, 9 and 12 months.

Eligibility criteria:
inclusion criteria: •the patients who had malignant biliary obstruction with a estimated survival \>4 months exclusion criteria: * the patients who had resectable biliary malignancy * the patients who had hilar obstruction * the patients who had duodenal obstruction * the patients who had international normalized ratio (inr)\>1.5 * the patients who did not give informed consent * the patients who had technically difficult structure for endoscopic retrograde cholangiopancreatography (ercp)

Keywords: malignant biliary obstruction