Conflict of interest of corresponding author: No financial disclosure.
RESULTS OF A JAPANESE MULTICENTER, RANDOMIZED TRIAL OF ENDOSCOPIC STENTING FOR NON-RESECTABLE PANCREATIC HEAD CANCER (JM-TEST): COVERED WALLSTENT VERSUS DOUBLELAYER STENT
Article first published online: 4 APR 2011
© 2011 The Authors. Digestive Endoscopy © 2011 Japan Gastroenterological Endoscopy Society
Volume 23, Issue 4, pages 310–315, October 2011
How to Cite
ISAYAMA, H., YASUDA, I., RYOZAWA, S., MAGUCHI, H., IGARASHI, Y., MATSUYAMA, Y., KATANUMA, A., HASEBE, O., IRISAWA, A., ITOI, T., MUKAI, H., ARISAKA, Y., OKUSHIMA, K., UNO, K., KIDA, M. and TAMADA, K. (2011), RESULTS OF A JAPANESE MULTICENTER, RANDOMIZED TRIAL OF ENDOSCOPIC STENTING FOR NON-RESECTABLE PANCREATIC HEAD CANCER (JM-TEST): COVERED WALLSTENT VERSUS DOUBLELAYER STENT. Digestive Endoscopy, 23: 310–315. doi: 10.1111/j.1443-1661.2011.01124.x
- Issue published online: 26 SEP 2011
- Article first published online: 4 APR 2011
- Received 21 July 2010; accepted 11 January 2011.
- biliary metallic stent;
- covered metallic stent;
- endoscopic treatment;
- obstructive jaundice;
- pancreas cancer
Background: No study has compared covered metallic stents with Tannenbaum stents. We evaluated the efficacy of the DoubleLayer stent (DLS) and Covered Wallstent (CWS) in patients with pancreatic head cancer (PHC).
Patients & Methods: This was a multicenter, prospective randomized study. Between October 2005 and December 2007, we enrolled 113 patients (58 DLS, 55 CWS) with unresectable PHC with distal biliary obstructions and observed them for at least 6 months.
Results: No significant difference in patient survival was found between groups, with a median survival of 231 and 248 days in the DLS and CWS groups, respectively. The cumulative stent patency was significantly higher (P = 0.0072) in the CWS group. The respective mean and median stent patency was 202 and 133 days in the DLS group and 285 and 419 days in the CWS group. The incidence of DLS occlusion (53.5%) was significantly higher than that of CWS (23.6%; P = 0.0019). The respective causes of occlusion were tumor overgrowth (0, 1), ingrowth (0, 2), sludge (24, 2), food impaction (3, 5), kinking bile duct (2, 0), and other (2, 3). Other complications were cholecystitis (0, 4), pancreatitis (0, 1), migration (1, 5), liver abscess (2, 0), and other (1, 2). No significant difference in the incidence of complications between groups was observed.
Conclusion: CWS had significantly longer patency than DLS for the management of PHC with obstructive jaundice. The incidence of complications other than stent occlusion was higher in CWS, but this difference did not reach significance.