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

Pancreatic Neoplasms Clinical Trial

Official title:

Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00487851
• Other study ID #: 2006/2:3
• Status: Withdrawn
• Phase: Phase 2
• First received: June 18, 2007
• Last updated: April 11, 2013
• Start date: March 2007
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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%.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Duodenal Neoplasms
• Neoplasms
• Pancreatic Neoplasms

Intervention

Procedure:
• surgery
hepaticojejunostomy and gastroenterostomy
• endoscopic strategy
Stent insertion

Locations

Country	Name	City	State
Sweden	Karolinksa university hospital	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No