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This study has been withdrawn prior to enrollment.
(Withdrawn)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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: March 2007
Study Completion Date: December 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Endoscopic treatment strategy
Procedure: endoscopic strategy
Stent insertion
Active Comparator: 2
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00487851

Locations
Sweden
Karolinksa university hospital
Huddinge, Sweden, 14186
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Farshad Frozanpor Karolinska institut Huddinge
  More Information

No publications provided

Responsible Party: Farshad Frozanpor, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00487851     History of Changes
Other Study ID Numbers: 2006/2:3
Study First Received: June 18, 2007
Last Updated: April 11, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Duodenal Neoplasms
Neoplasms
Pancreatic Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Duodenal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014