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

Phase 2

Withdrawn

• Conditions: Pancreatic Neoplasms; Biliary Tract Neoplasms; Duodenal Neoplasms
• Interventions: Procedure: surgery; Procedure: endoscopic strategy

• Registration Number: NCT00487851
• Lead Sponsor: Karolinska Institutet

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 Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-06-18
• Study First Submitted QC: 2007-06-18
• Study First Posted: 2007-06-19
• Primary Completion: 2012-03
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-11
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	surgery	Surgical treatment strategy
1	endoscopic strategy	Endoscopic treatment strategy

Primary Outcome Measures

Name	Time	Method
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.	1, 3 and 6 months

Trial Locations

Locations (1)

Karolinksa university hospital; 🇸🇪 Huddinge, Sweden