醫(yī)學(xué)交流課件：Irradiationstent–new hope toptswithunresectableMBO

1、Irradiation stent newhopeto pts with unresectable MBO,Malignant Biliary Tract Obstruction (MBO),Caused by various carcinomas Silent and insidious clinical process 1020% of pts can undergo surgery once obstructive jaundice occurred High recurrence rate Dismal long-term survival after resection 3-year

2、 survival rates: 18-52% 5-year survival rates: 5-31%,CA Cancer J Clin, 2009. 59: 225-49; 2011. 61(2): 69-90; 2012. 62(1): 10-29 Transplant Proc, 2009. 41: 4023-35; Lancet, 2005. 366: 1303-14 N Engl J Med,1999.341:1368-1378; Oncologist,2004.9:43-57; J Surg Oncol,1997. 64:242-245,Pancreatic carcinoma

3、(59-82 %) Cholangiocarcinoma (17-24%) Metastatic nodes (8-17 %) Gallbladder carcinoma (5-18%) Ampullary carcinoma (3-15%),Am J Gastroenterol. 2013 ;108(11):1713-22 Gastrointest Endosc. 2010;72(5):915-23 Cardiovasc Intervent Radiol. 2012;35(1):127-38 Clin Gastroenterol Hepatol. 2013;11(1):27-37,Commo

4、n Diseases of MBO,Studies published 1960 - 2010 20/83 studies,6712 pts A nonsignificant improvement in OS AT vs. surgery alone No difference in OS Gallbladder vs. other bile duct tumors Greater benefit in OS Chemotherapy/chemoradiotherapy vs. RT alone In pts with LN-positive and R1 disease,J Clin On

5、col, 2012. 30(16):1934-40.,Adjuvant therapy (AT) to MBO,Results from a systematic review and meta-analysis,Gemcitabine + Cisplatin（vs. Gemcitabine） Gemcitabine + Oxaliplatin (vs. Best supportive care/ Fluorouracil + Folic acid）,Chemotherapy to MBO,N Engl J Med, 2010. 362(14): 1273-81. J Clin Oncol,

6、2010. 28(30): p. 4581-6.,Results from two RCTs,Lancet, 1987. 2(8550): 57-62 Am J Gastroenterol, 2008. 103(2): 458-73 Endoscopy, 2012. 44(3): 277-98,Stenting- ESGE clinical guideline,Palliative drainage of MBO should be first attempted -Recommendation grade A Insertion of a plastic stent -Recommendat

7、ion grade C Unestablished diagnosis of malignancy Expected survival is 4 mos,A main palliative therapy of unresectable MBO in relief of jaundice and improvement of QOL No benefits in controlling the growth of cancer and prolonging survival directly,Restenosis-a pitfall of stent placement,Stenting- N

8、CCN guideline,kill two birds with one stone,+,=,Stenting + Brachytherapy,125I seeds loaded stent,125I seeds loaded biliary stent,Procedure,Irradiation stent,Control stent,Inclusion Criteria MBO with histologically or cytologically confirmation Symptoms related to BO Unresectability or refuse surgery

9、 Exclusion criteria Suspected benign BO Be contraindicated to be dilated enough Perforation of any ducts Presence of metallic biliary stent or bile duct surgery Be contraindicated to PTC Active hepatitis Intrahepatic metastases that extensively involves both lobes of the liver,Randomization,Primary

10、Endpoints Technical success Jaundice relief Radiation safety Complications Secondary endpoint Overall survival,n=24,n=12,n=11,One withdrew from the trial,Unicentric phase 2 rial,Stent patency,Overall survival,Median Survival 7.4 vs. 2.5 mos, Mean survival 8.03 vs. 3.36 mos,Conclusions,Treatment with

11、 the biliary irradiation stent in pts with MBO appears safe and technically feasible, has benefits in relieving jaundice, and seems to extend survival when compared to a conventional uncovered biliary stent.,Gastroenterol Res Pract.2016;2016:3296801,Evidence for practice,Limitations of the phase 2 t

12、rial,Interim conclusion Small sample size (n=23) Unicentric Unsatisfied analysis to stent patency,Irradiation stent,Control stent,Inclusion Criteria MBO with histologically or cytologically confirmation Symptoms related to BO Unresectability or refuse surgery Exclusion criteria Suspected benign BO B

13、e contraindicated to be dilated enough Perforation of any ducts Presence of metallic biliary stent or bile duct surgery Be contraindicated to PTC Active hepatitis Intrahepatic metastases that extensively involves both lobes of the liver,Randomization,Primary Endpoints Stent patency Secondary endpoin

14、t Overall survival Safety Clinical success QOL,n=328,n=164,n=164,Multicentric phase 3 RCT,Nov. 2013 Sep. 2016 20 center, China,To further assess the efficacy of irradiation stent compared to uncovered SEMS in pts with unresectable MBO,Trial profile,Technical success rate: 9938 % (ISG) vs 9873 % (CG)

15、 (p=0.618) Relief of jaundice within 1wk: 85.53 % (ISG) vs 82.58 %(CG) (p=0.474),328 pts 164 in ISG vs. 164 in CG 161 (IRS) vs. 164 (SEMS) Lost to F/U: 10 vs. 7 ITT analysis: 164 vs. 164,Stent patency,Cumulative stent restenosis rate (ISG vs CG, p=0.010): 9.53 % vs 1667% 90 days 1795% vs 26.28% 180

16、days 20.34% vs 34.01% 360 days,Overall survival,Median Survival : 201 days vs 140 days (p=0.037),Complications,As compared with an uncovered SEMS, insertion of an irradiation stent provides longer patency and improves the overall survival in pts with unresectable MBO.,Conclusion of the phase 3 trial,Irradiation biliary stent Kill two birds in one stone Feasible in technique and safe in treating MBO Beneficial in prolonging the patency and survival in pts with unresectable MBO, versus uncovered biliary SEMS (based on an unicentric phase 2 trial and