Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer
Primary Purpose
Pancreatic Neoplasms, Biliary Tract Neoplasms, Duodenal Neoplasms
Status
Withdrawn
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
surgery
endoscopic strategy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Pancreatic, cancer, Periampullay, Neoplasms, Biliary, Duodenal, Jaundice, obstruction, pancreas cancer, Pancreatic cancer
Eligibility 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.)
Sites / Locations
- Karolinksa university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Endoscopic treatment strategy
Surgical treatment strategy
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00487851
Brief Title
Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer
Official Title
Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms, Biliary Tract Neoplasms, Duodenal Neoplasms
Keywords
Pancreatic, cancer, Periampullay, Neoplasms, Biliary, Duodenal, Jaundice, obstruction, pancreas cancer, Pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Endoscopic treatment strategy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Surgical treatment strategy
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
hepaticojejunostomy and gastroenterostomy
Intervention Type
Procedure
Intervention Name(s)
endoscopic strategy
Intervention Description
Stent insertion
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farshad Frozanpor
Organizational Affiliation
Karolinska institut Huddinge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinksa university hospital
City
Huddinge
ZIP/Postal Code
14186
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer
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