Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer
Experience shows that patients with advanced periampullary cancer suffer not only from
jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and
nutritional difficulties. Ten years ago, the only palliative treatment for these patients
was a bypass operation for bile flow and intestinal passage. This operation was often
associated with a high morbidity. Developments in endoscopic treatments allow palliation
with lower morbidity. However, stent treatment is not free of problems like stent
dysfunction. During the last ten years, anesthesia and surgical techniques have developed
which allow lower postoperative morbidity compared to earlier treatments. A total of 70
patients were randomized to surgery with hepaticojejunostomy on Roux loop and
gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile
duct and so-called duodenal stent. Based on the inclusion of 70 patients, we expected a 20%
difference in some of the primary variables with a power of 80%.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome consist of a composite score (i.e. number of hospitalizations, episodes of cholangitis, degree of jaundice, other complications requiring therapeutic interventions). Secondary outcome are QoL,hospital stay and health economic burden.
1, 3 and 6 months
No
Farshad Frozanpor
Principal Investigator
Karolinska institut Huddinge
Sweden: Regional Ethical Review Board
2006/2:3
NCT00487851
March 2007
December 2012
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