A Phase 2 interventional study of surgery and endoscopic strategy in Pancreatic Neoplasms, Biliary Tract Neoplasms and Duodenal Neoplasms, sponsored by Karolinska Institutet. Withdrawn at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2013-04-12.
Sponsored by Karolinska Institutet · Phase 2, Interventional, and Treatment
Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable 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%.
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Exclusion Criteria:
Endoscopic treatment strategy
Procedure: endoscopic strategy
Surgical treatment strategy
Procedure: surgery
hepaticojejunostomy and gastroenterostomy
Stent insertion
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.
Time frame: 1, 3 and 6 months
This study is withdrawn, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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