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

Karolinska Institute

Status and phase

Withdrawn

Phase 2

Conditions

Duodenal Neoplasms

Biliary Tract Neoplasms

Pancreatic Neoplasms

Treatments

Procedure: surgery

Procedure: endoscopic strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT00487851

2006/2:3

Details and patient eligibility

About

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

Full 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%.

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction.
The patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as "reasonable" and both treatment strategies are considered "applicable".

Exclusion criteria