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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487851
Recruitment Status : Withdrawn (Withdrawn)
First Posted : June 19, 2007
Last Update Posted : April 12, 2013
Information provided by (Responsible Party):
Farshad Frozanpor, Karolinska Institutet

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

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Biliary Tract Neoplasms Duodenal Neoplasms Procedure: surgery Procedure: endoscopic strategy Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer
Study Start Date : March 2007
Estimated Primary Completion Date : March 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Endoscopic treatment strategy
Procedure: endoscopic strategy
Stent insertion
Active Comparator: 2
Surgical treatment strategy
Procedure: surgery
hepaticojejunostomy and gastroenterostomy

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00487851

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

Responsible Party: Farshad Frozanpor, MD, PhD, Karolinska Institutet Identifier: NCT00487851     History of Changes
Other Study ID Numbers: 2006/2:3
First Posted: June 19, 2007    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: April 2013

Keywords provided by Farshad Frozanpor, Karolinska Institutet:
pancreas cancer
Pancreatic cancer

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