EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— EUFURO  

Official title:

Endoscopic Ultrasound (EUS) and PET-CT Based Follow-up of Patients Radically Resected for Cancer of the Oesophagus, Stomach or Pancreas.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02209415
• Other study ID #: 2011-41-5702
• Status: Active, not recruiting
• Phase: N/A
• First received: November 28, 2011
• Last updated: August 4, 2014
• Start date: April 2011
• Est. completion date: August 2016

Study information

• Verified date: August 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Datatilsynet
• Study type: Interventional

Clinical Trial Summary

Follow-up after successful operative treatment of cancer in the esophagus, stomach or pancreas in order to detect recurrent disease is a controversial topic.

This is because the methods and the consequence of following these patients is unknown.

Therefore the investigators will randomize these patients in to two groups:

1. One group of patients will be offered visits with a specialist surgeon in a outpatient setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is the current standard at our department.

2. The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same intervals as the first group.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: August 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.

Study Design

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Cancer
• Stomach Neoplasms

Intervention

Behavioral:
• standard follow-up
Outpatient clinic visits

Procedure:
• PET/CT and EUS
PET/CT and EUS

Locations

Country	Name	City	State
Denmark	Center for Surgical Ultrasound, Department of upper surgical gastroenterology	Odense	Region of Southern Denmark

Sponsors (2)

Lead Sponsor	Collaborator
Michael Bau Mortensen	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients eligible for treatment	Does early detection of recurrent disease translate in to more patients being eligible for oncologic treatment?	2 years	No