Introduction: Cancer of the pancreas, gallbladder and bile ducts is the most common cause of malignant neoplastic obstruction of the biliary tree. In the case of advanced cancer, unresectable by surgery, the prognosis is poor, with a survival rate at 5 years less than 2%. We present preliminary results of an ongoing prospective controlled trial to compare covered (Niti-S Biliary ComVi) with uncovered (Niti-s D type) self-conformable metal stent for palliation of primary malignant extra-hepatic biliary strictures in patients with inoperable extrahepatic malignant biliary obstruction. No RCTs are present in literature comparing the two different type of self-conformable stents. Methods: 47 patients (26 male and 21 female, median age 80 years) with malignant extra-hepatic biliary strictures were randomized for the placement of a covered (N=23) or a uncovered (N= 21) stent. Inclusion criteria were: extra-hepatic malignant biliary CBD obstruction; bilirubin >5 mg/dL; inoperable neoplasia; age ≥ 18 ys; informed consent. Results: Median ERCP time with stent placement was 30 min (range 15-100). Placement was successful in 100% of patients with the uncovered and 96% (22) patients with covered stent. In 1 patient, the covered stent was removed because of release stent failure. After 1 week a decrease of at least 30% was observed in 23 pts (9 covered (60%) and 14 uncovered (78%) stents) for GOT; in 27 (12 covered (71%) and 15 uncovered (83%) stents) for GPT; in 26 pts (11 covered (65%) and 15 uncovered (83%) stents ) for total bilirubin and in 24 pts (10 covered (67%) and 14 (82%) uncovered) for direct bilirubin. Elevation of bilirubin of at least 30% occurred in 2 pts (1 covered and 1 uncovered stent). No other complications were observed. Median overall survival was 89 days (95%CI 9.3-168.7) and 194 days (95%CI 73.-314.1) for covered and uncovered stents, respectively (p=ns). Conclusions: An higher decrease of cholestastic parameters among uncovered stents was observed. No long term adverse events were observed in 6 months follow-up. The study is actually ongoing and a most extensive analysis will be done in the next months.
Self-conformable covered vs self-conformable uncovered metallic stents in the palliative treatment of malignant extra-hepatic biliary stricture: a multicentric randomized study – preliminary results
Mangiavillano B;
2015-01-01
Abstract
Introduction: Cancer of the pancreas, gallbladder and bile ducts is the most common cause of malignant neoplastic obstruction of the biliary tree. In the case of advanced cancer, unresectable by surgery, the prognosis is poor, with a survival rate at 5 years less than 2%. We present preliminary results of an ongoing prospective controlled trial to compare covered (Niti-S Biliary ComVi) with uncovered (Niti-s D type) self-conformable metal stent for palliation of primary malignant extra-hepatic biliary strictures in patients with inoperable extrahepatic malignant biliary obstruction. No RCTs are present in literature comparing the two different type of self-conformable stents. Methods: 47 patients (26 male and 21 female, median age 80 years) with malignant extra-hepatic biliary strictures were randomized for the placement of a covered (N=23) or a uncovered (N= 21) stent. Inclusion criteria were: extra-hepatic malignant biliary CBD obstruction; bilirubin >5 mg/dL; inoperable neoplasia; age ≥ 18 ys; informed consent. Results: Median ERCP time with stent placement was 30 min (range 15-100). Placement was successful in 100% of patients with the uncovered and 96% (22) patients with covered stent. In 1 patient, the covered stent was removed because of release stent failure. After 1 week a decrease of at least 30% was observed in 23 pts (9 covered (60%) and 14 uncovered (78%) stents) for GOT; in 27 (12 covered (71%) and 15 uncovered (83%) stents) for GPT; in 26 pts (11 covered (65%) and 15 uncovered (83%) stents ) for total bilirubin and in 24 pts (10 covered (67%) and 14 (82%) uncovered) for direct bilirubin. Elevation of bilirubin of at least 30% occurred in 2 pts (1 covered and 1 uncovered stent). No other complications were observed. Median overall survival was 89 days (95%CI 9.3-168.7) and 194 days (95%CI 73.-314.1) for covered and uncovered stents, respectively (p=ns). Conclusions: An higher decrease of cholestastic parameters among uncovered stents was observed. No long term adverse events were observed in 6 months follow-up. The study is actually ongoing and a most extensive analysis will be done in the next months.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
