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| Sponsor: | Karolinska Institutet |
|---|---|
| Information provided by: | Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT00487851 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer |
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Endoscopic treatment strategy
|
Procedure: endoscopic strategy
Stent insertion
|
|
Active Comparator: 2
Surgical treatment strategy
|
Procedure: surgery
hepaticojejunostomy and gastroenterostomy
|
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%.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Farshad Frozanpor, CLINTEC, KI Hudinge |
| ClinicalTrials.gov Identifier: | NCT00487851 History of Changes |
| Other Study ID Numbers: | 2006/2:3 |
| Study First Received: | June 18, 2007 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Sweden: Regional Ethical Review Board |
|
Pancreatic cancer Periampullay Neoplasms Biliary |
Duodenal Jaundice obstruction pancreas cancer Pancreatic cancer |
|
Biliary Tract Neoplasms Neoplasms Duodenal Neoplasms Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Biliary Tract Diseases Digestive System Diseases |
Intestinal Neoplasms Gastrointestinal Neoplasms Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |