Background. Up to 1600 Canadians/yr suffer a serious complication due to the diagnostic test ERCP (endoscopic retrograde cholangiopancreatography) used in the management of patients with suspected biliary obstruction. MRCP (magnetic resonance cholangiopancreatography) is a new highly accurate noninvasive alternative that is not associated with any significant complications. / Aims. To assess the real-life effectiveness and costs of MRCP versus ERCP in a planned interim analysis of a randomized clinical trial, in intermediate risk patients. To assist in the decision regarding study continuation versus termination. / Methods. 200 patients with a clinical and/or ultrasonographic (US) suspicion of obstruction were randomized to MRCP or ERCP, using block allocation stratified by level of obstruction. The primary endpoint was the occurrence of a negative outcome attributable to the biliopancreatic disease or procedures within 12 months of randomization. Secondary outcomes included complication-related length of stay (CRLOS), number of procedures, costs, mortality and accuracy. / Results. 102 patients were randomized to MRCP and 98 to ERCP with mean ages of 56.4 +/- 18 (SD) and 51.8 +/- 19 yrs, respectively. Median follow-up was 12 months. According to intention-to-treat analysis, 18 (17.6%) MRCP patients had a complication (CRLOS = 0.80 d/patient (excluding 1 outlier with CRLOS = 157d) versus 14 (14.3%) ERCP patients (CRLOS = 0.68d/patient); difference = 3.3% (95%CI: -7 to 13%). There were 45 fewer ERCPs but 90 extra MRCPs in the MRCP arm. ERCP was "dominant", with both marginally lower complications and lower costs by $1411/person (ITT). There was neither evidence for confounding nor effect modification. / Conclusions. In this interim analysis, it appears that a strategy that involves a screening MRCP in this group of patients is not cost-effective. The results of this primary analysis are unlikely to change with the recruitment of 200 additional patients into the trial.
| Identifer | oai:union.ndltd.org:LACETR/oai:collectionscanada.gc.ca:QMM.33026 |
| Date | January 2001 |
| Creators | Romagnuolo, Joseph. |
| Contributors | Joseph, L. (advisor) |
| Publisher | McGill University |
| Source Sets | Library and Archives Canada ETDs Repository / Centre d'archives des thèses électroniques de Bibliothèque et Archives Canada |
| Language | English |
| Detected Language | English |
| Type | Electronic Thesis or Dissertation |
| Format | application/pdf |
| Coverage | Master of Science (Department of Epidemiology and Biostatistics.) |
| Rights | All items in eScholarship@McGill are protected by copyright with all rights reserved unless otherwise indicated. |
| Relation | alephsysno: 001838100, proquestno: MQ75340, Theses scanned by UMI/ProQuest. |
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