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

Sponsor

Michael Bau Mortensen (Other)

Overall Status

Unknown status

CT.gov ID

NCT02209415

Collaborator

Odense University Hospital (Other)

182

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Stomach Cancer Pancreatic Cancer	Behavioral: standard follow-up Procedure: PET/CT and EUS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

182 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Apr 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard outpatient follow-up Outpatient clinic visits 3,6,9,12,18 and 24 mths after surgery	Behavioral: standard follow-up Outpatient clinic visits
Experimental: Intervention PET/CT and EUS PET/CT and EUS at 3,6,9,12,18 and 24 months after surgery	Procedure: PET/CT and EUS PET/CT and EUS

Arm

Intervention/Treatment

Active Comparator: Standard outpatient follow-up

Outpatient clinic visits 3,6,9,12,18 and 24 mths after surgery

Behavioral: standard follow-up

Outpatient clinic visits

Experimental: Intervention PET/CT and EUS

PET/CT and EUS at 3,6,9,12,18 and 24 months after surgery

Procedure: PET/CT and EUS

PET/CT and EUS

Outcome Measures

Primary Outcome Measures

Number of patients eligible for treatment [2 years]
Does early detection of recurrent disease translate in to more patients being eligible for oncologic treatment?

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Surgical Ultrasound, Department of upper surgical gastroenterology	Odense	Region of Southern Denmark	Denmark	5000

Sponsors and Collaborators

Michael Bau Mortensen
Odense University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Bau Mortensen, MD, PhD, Odense University Hospital

ClinicalTrials.gov Identifier:

NCT02209415

Other Study ID Numbers:

2011-41-5702

First Posted:

Aug 5, 2014

Last Update Posted:

Aug 5, 2014

Last Verified:

Aug 1, 2014

Additional relevant MeSH terms:

Pancreatic Neoplasms

Stomach Neoplasms

Study Results

No Results Posted as of Aug 5, 2014