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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer

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

Detailed Summary: 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%.
Sponsor: Karolinska Institutet

Current Primary Outcome: 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 ]

Original Primary Outcome: The number of hospitalization. Obstruction of respective GI-segment and other specific complications related to allocated treatment strategies. Quality of life protocol. Health economy. [ Time Frame: 1, 3 and 6 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Karolinska Institutet

Dates:
Date Received: June 18, 2007
Date Started: March 2007
Date Completion:
Last Updated: April 11, 2013
Last Verified: April 2013