Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT00487851
Brief 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%.
Study:
NCT00487851
Study Brief:
Protocol Section:
NCT00487851