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Sponsored by: |
Karolinska Institutet |
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Information provided by: | Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT00487851 |
Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer
Condition | Intervention | Phase |
---|---|---|
Pancreatic Neoplasms Biliary Tract Neoplasms Duodenal Neoplasms |
Procedure: surgery Procedure: endoscopic strategy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer |
Estimated Enrollment: | 70 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2010 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Endoscopic treatment strategy
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Procedure: endoscopic strategy
Stent insertion
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2: Active Comparator
Surgical treatment strategy
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Procedure: surgery
hepaticojejunostomy and gastroenterostomy
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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%.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Farshad Frozanpor | farshad.frozanpor@sodersjukhuset.se |
Sweden | |
Karolinksa university hospital | Recruiting |
Huddinge, Sweden, 14186 | |
Contact: Urban Arnelo Urban.Arnelo@ki.se |
Principal Investigator: | Farshad Frozanpor | Karolinska institut Huddinge |
Responsible Party: | CLINTEC, KI Hudinge ( Farshad Frozanpor ) |
Study ID Numbers: | 2006/2:3 |
Study First Received: | June 18, 2007 |
Last Updated: | December 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00487851 |
Health Authority: | Sweden: Regional Ethical Review Board |
Pancreatic cancer Periampullay Neoplasms Biliary |
Duodenal Jaundice obstruction pancreas cancer Pancreatic cancer |
Biliary Tract Neoplasms Digestive System Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Endocrine System Diseases Intestinal Diseases Pancrelipase Intestinal Neoplasms Duodenal Neoplasms |
Digestive System Diseases Biliary Tract Diseases Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Jaundice Duodenal Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site |