⁎⁎⁎⁎⁎⁎Selected for presentation at the asge plenary session.4465 Scheduled vs. as required stent exchanges for malignant biliary obstruction. a prospective randomized study.

Autor: Mokhashi, Mahesh S., Rawls, Elaine, Tarnasky, Paul R., Patel, Rig S., Tang, Howard, Yeoh, K.G., Hawes, Robert H., Cotton, Peter B., Cunningham, John T.
Zdroj: Gastrointestinal Endoscopy; April 2000, Vol. 51 Issue: 4 pAB142-AB142, 1p
Abstrakt: Background: The best strategy for stent exchange in malignant biliary obstruction is not known. Some experts advocate routine prophylactic stent exchange every 3-4 months, a strategy which might lead to many unnecessary procedures. Aim: A prospective randomized study comparing 2 commonly practiced strategies: scheduled vs. as required stent exchanges. Methods: Pts. requiring biliary stenting for malignant obstruction were randomized to either (i) scheduled exchanges every 4 months or earlier if stents occluded (SCH) or (ii) exchanges only when stents occluded (PRN). End points were either metal stenting, surgery, death or resolution of stricture not needing stenting. LFTs were monitored monthly in both gps. Occlusion was defined as a doubling of nadir alkaline phosphatase or bilirubin. Results: Of the 69 pts. recruited 5 were excluded (4- benign; 1-immediate surgery). 30 pts. (9 M) were randomized to SCH and 34 pts. (15 M) to the PRN arm. The 2 gps. were comparable in all respects (SCH : PRN) mean ages (69:72); diagnoses (%) pancreatic Ca (73 : 76), cholangioCa (10 : 14), metastases (13 : 9) and ampullary Ca (1 : 0); mean comorbidity indices (0.83 : 0.97); & stent diameters (≥10 Fr). Number of ERCPs per pt. in the 2 gps. was not different, 2.1(SCH) vs 2(PRN). Number of stents per patient [(SCH : PRN): 1 stent (15:15); 2 stents (4:10); 3 stents (5:5); 4 stents (3:2); 5 stents (3:2)] and end points [death (22:26); metal stenting (6:7); surgery (1:0); misc (1:1)] were similar. Indications for metal stenting (SCH:PRN) duodenal stenosis (3:7) and rapid reocclusion (3:1) were similar. 43% pts. (SCH) and 47% pts. (PRN) died with patent stents. The mean stent survival was 90 d (SCH) vs 97 d (PRN), (p=NS). There was no difference in the survival time of each serial stent between the two gps. There was 1 episode of stent related cholangitis leading to death in the PRN arm on day 108 (T=3.82; p>0.05). There was no difference in the number of episodes of cholangitis; 10 in SCH vs 15 in PRN (T=1.29763; p>0.25). Time to death or other endpoints was not different in the two gps. (p=0.99). Conclusion: (1) There is no difference in measured outcomes when plastic stent exchanges are performed electively every 4 months or on an as required basis for biochemical occlusion in malignant biliary obstruction. (2) Using biochemical occlusion rather than clinical occlusion may result in a lower stent related mortality than previously reported. (3) Other factors (e.g. physical proximity, personal preference) should be used when selecting a strategy.
Databáze: Supplemental Index