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Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study


N/A
18 Years
85 Years
Open (Enrolling)
Both
Pancreatic Cancer, Periampullary Tumor

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Trial Information

Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study


Inclusion Criteria:



1. Preoperatively

- Patients with stent treated tumor in the pancreatic head or periampullary
planned for pancreaticoduodenectomy

- The patient jaundice should have worn off and there should be no signs of
duodenal obstruction

- The patient has given informed consent after verbal and written information in
accordance with approved ethics application

- The patient has no anatomical conditions making endoscopic therapy impossible
such as previous Billroth II or Gastric Bypass.

2. Intraoperatively

- Peroperative findings of of carcinomatosis, metastases or local irresectability
who oppose radical surgery

- Surgical double bypass should be technically feasible

- The patient has given informed consent after verbal and written information in
accordance with approved ethics application

Exclusion Criteria:

- Peroperative signs of dysfunction on biliary stent

- Peroperative findings of gastric outlet obstruction

- Surgical double bypass not technically feasible

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Morbidity

Outcome Description:

Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.

Outcome Time Frame:

Day 1-30 after randomization

Safety Issue:

No

Principal Investigator

Lars Fändriks, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Göteborg University

Authority:

Sweden: Regional Ethical Review Board

Study ID:

Double bypass vs Stent

NCT ID:

NCT01569282

Start Date:

October 2011

Completion Date:

October 2015

Related Keywords:

  • Pancreatic Cancer
  • Periampullary Tumor
  • Surgical bypass
  • Hepaticojejunostomy
  • Gastrojejunostomy
  • Biliary stent
  • Enteral stent
  • Pancreatic Neoplasms

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