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

This study is currently recruiting participants.
Verified by Karolinska Institutet, September 2007

Sponsored by: Karolinska Institutet
Information provided by: Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00487851
  Purpose

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


Condition Intervention Phase
Pancreatic Neoplasms
Biliary Tract Neoplasms
Duodenal Neoplasms
Procedure: surgery
Procedure: endoscopic strategy
Phase II

MedlinePlus related topics:   Cancer    Endoscopy    Intestinal Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Pancrelipase    Ultrase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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. [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   70
Study Start Date:   March 2007
Estimated Study Completion Date:   March 2010

Arms Assigned Interventions
1: Active Comparator
Endoscopic treatment strategy
Procedure: endoscopic strategy
Stent insertion
2: Active Comparator
Surgical treatment strategy
Procedure: surgery
hepaticojejunostomy and gastroenterostomy

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%.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487851

Contacts
Contact: Farshad Frozanpor     farshad.frozanpor@sodersjukhuset.se    

Locations
Sweden
Karolinksa university hospital     Recruiting
      Huddinge, Sweden, 14186
      Contact: Urban Arnelo         Urban.Arnelo@ki.se    

Sponsors and Collaborators
Karolinska Institutet

Investigators
Principal Investigator:     Farshad Frozanpor     Karolinska institut Huddinge    
  More Information


Responsible Party:   CLINTEC, KI Hudinge ( Farshad Frozanpor )
Study ID Numbers:   2006/2:3
First Received:   June 18, 2007
Last Updated:   December 6, 2007
ClinicalTrials.gov Identifier:   NCT00487851
Health Authority:   Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Pancreatic  
cancer  
Periampullay  
Neoplasms  
Biliary  
Duodenal
Jaundice
obstruction
pancreas cancer
Pancreatic cancer

Study placed in the following topic categories:
Biliary Tract Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Endocrine System Diseases
Intestinal Diseases
Pancrelipase
Intestinal Neoplasms
Duodenal Neoplasms
Digestive System Diseases
Biliary Tract Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Jaundice
Duodenal Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 07, 2008




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