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Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer

Phase 2
Not Enrolling
Pancreatic Neoplasms, Biliary Tract Neoplasms, Duodenal Neoplasms

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Trial Information

Endoscopic Strategy Versus Surgical by Pass in Nonresectable 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%.

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.)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

1, 3 and 6 months

Safety Issue:


Principal Investigator

Farshad Frozanpor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinska institut Huddinge


Sweden: Regional Ethical Review Board

Study ID:




Start Date:

March 2007

Completion Date:

December 2012

Related Keywords:

  • Pancreatic Neoplasms
  • Biliary Tract Neoplasms
  • Duodenal Neoplasms
  • Pancreatic
  • cancer
  • Periampullay
  • Neoplasms
  • Biliary
  • Duodenal
  • Jaundice
  • obstruction
  • pancreas cancer
  • Pancreatic cancer
  • Biliary Tract Neoplasms
  • Neoplasms
  • Duodenal Neoplasms
  • Pancreatic Neoplasms