NCT00487851

Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer

Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer

Detailed description

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%.

Conditions

• Pancreatic Neoplasms
• Biliary Tract Neoplasms
• Duodenal Neoplasms

Interventions

Type	Name	Description
PROCEDURE	surgery	hepaticojejunostomy and gastroenterostomy
PROCEDURE	endoscopic strategy	Stent insertion

Timeline

• Start date: 2007-03-01
• Primary completion: 2012-03-01
• Completion: 2012-12-01
• First posted: 2007-06-19
• Last updated: 2013-04-12

Locations

1 site across 1 country: Sweden