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

This study has been withdrawn prior to enrollment.
(Withdrawn)
Sponsor:
Information provided by (Responsible Party):
Farshad Frozanpor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00487851
First received: June 18, 2007
Last updated: April 11, 2013
Last verified: April 2013

June 18, 2007
April 11, 2013
March 2007
March 2012   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00487851 on ClinicalTrials.gov Archive Site
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Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer
Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer

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

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%.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Neoplasms
  • Biliary Tract Neoplasms
  • Duodenal Neoplasms
  • Procedure: surgery
    hepaticojejunostomy and gastroenterostomy
  • Procedure: endoscopic strategy
    Stent insertion
  • Active Comparator: 1
    Endoscopic treatment strategy
    Intervention: Procedure: endoscopic strategy
  • Active Comparator: 2
    Surgical treatment strategy
    Intervention: Procedure: surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
March 2012   (final data collection date for primary outcome measure)

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.)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00487851
2006/2:3
Yes
Farshad Frozanpor, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Farshad Frozanpor Karolinska institut Huddinge
Karolinska Institutet
April 2013

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