Randomised Trial of Coil (EndocoilTM) Stent Versus Plastic Stent in Malignant Biliary Tract Obstruction

Moon, Young Myung; Kang, Jin Kyung; Park, In Suh; Chung, Jae Bock; Song, Si Young; Lee, Don Haeng

Abstract

BACKGROUND AND AIMS
Endoscopic stent placement has become accepted palliative therapy for malignant biliary tract obstruction (MBTO). The main problem of plastic stent are the clogging or migration. The new self expandable super-elastic metallic coil stent (Endo-coilTM, Instent Inc.) is claimed to allow large lumen and prolong biliary-stent patency. In a prospective randomised trial, we compared the efficacy and frequency of stent dysfunction of EndocoilTMand plastic stent (PercuflexR, Microvasive Co.). METHOD: Between Aug. 1994 and Mar. 1995, we assigned 29 patients (21 males and 8 females, mean age 63 years) with unresectable MBTO due to cancer of bile duct (17), pancreas (6) periampullary (3), gallbladder (2) and perichoedochal LN (1). Thirteen of patients under-went EndocoilTMstents (24 Fr) and other 16 patients underwent plastic stents (12 Fr) insertion via transpapillary route. Successful insertion of stents was attained all cases and no serious complication occured.
RESULTS
All patients with EndocoilTM stents and 11 (68%) patients with plastic stents were relieved completely from jaundice (T. bilirubon <3.0 mg/dl). There was no differences in decreasement of bilirubin between two groups after 7 days and 30 days after stents insertion. Median patency of the stents was significantly prolonged in patients with EndocoilTM stents compared with those with plastic stents(205 days vs 92 days). The stent dysfunction was noted 2 cases (15%) in EndocoilTM due to tumor ingrowth. In contrast, stent dysfunction was occured in 10 cases (62%) of plastic stents due to clogging (7 cases) and migration (3 cases). The patients' overall median survival was not different significantly between two groups (EndocoilTM250 days vs plastic 196 days).
CONCLUSIONS
Both ndocoilTMand plastic stents offer effective bile drainage in MBTO. However EndocoilTM stents may be more effective for providing longer periods of drainage due to lower frequency of stent dysfuction than plastic stents.