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

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ClinicalTrials.gov Identifier: NCT00487851
Recruitment Status : Withdrawn (Withdrawn)
First Posted : June 19, 2007
Last Update Posted : April 12, 2013
Sponsor:
Information provided by (Responsible Party):
Farshad Frozanpor, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE June 18, 2007
First Posted Date  ICMJE June 19, 2007
Last Update Posted Date April 12, 2013
Study Start Date  ICMJE March 2007
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2007)
The number of hospitalization. Obstruction of respective GI-segment and other specific complications related to allocated treatment strategies. Quality of life protocol. Health economy. [ Time Frame: 1, 3 and 6 months ]
Change History Complete list of historical versions of study NCT00487851 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer
Official Title  ICMJE Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Neoplasms
  • Biliary Tract Neoplasms
  • Duodenal Neoplasms
Intervention  ICMJE
  • Procedure: surgery
    hepaticojejunostomy and gastroenterostomy
  • Procedure: endoscopic strategy
    Stent insertion
Study Arms  ICMJE
  • Active Comparator: 1
    Endoscopic treatment strategy
    Intervention: Procedure: endoscopic strategy
  • Active Comparator: 2
    Surgical treatment strategy
    Intervention: Procedure: surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 11, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2007)
50
Actual Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00487851
Other Study ID Numbers  ICMJE 2006/2:3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Farshad Frozanpor, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Farshad Frozanpor Karolinska institut Huddinge
PRS Account Karolinska Institutet
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP