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

NCT ID: NCT00487851

Last Updated: 2013-04-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2012-12-31

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%.

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms; Duodenal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Endoscopic treatment strategy

Group Type: ACTIVE_COMPARATOR

endoscopic strategy

Intervention Type: PROCEDURE

Stent insertion

2

Surgical treatment strategy

Group Type: ACTIVE_COMPARATOR

surgery

Intervention Type: PROCEDURE

hepaticojejunostomy and gastroenterostomy

Interventions

surgery

hepaticojejunostomy and gastroenterostomy

Intervention Type: PROCEDURE

endoscopic strategy

Stent insertion

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Non consent.
• The patients' general condition will not tolerate either treatment (strategy).
• Previous laparotomy or laparoscopy.
• Life expectancy < 3 months.
• Inability to participate (language, social, etc.)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Farshad Frozanpor

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Farshad Frozanpor

Role: PRINCIPAL_INVESTIGATOR

Karolinska institut Huddinge

Locations

Karolinksa university hospital

Huddinge, , Sweden

Countries

Sweden

Other Identifiers

2006/2:3

Identifier Type: -

Identifier Source: org_study_id