Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma

November 16, 2021 updated by: Kristian Kiim Jensen, Bispebjerg Hospital
The aim of this study is to examine the long-term outcomes after curatively intended resection of duodenal adenocarcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Copenhagen NV, Copenhagen, Denmark, DK-2400
        • Kristian Schaumburg Kiim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients subjected to resection of primary duodenal adenocarcinoma

Description

Inclusion Criteria:

  • Patients subjected to resection of primary duodenal adenocarcinoma

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing resection of primary duodenal cancer
Tumors comprised histologically confirmed adenocarcinomas in the duodenum excluding adenocarcinoma of the ampulla of Vater and adenocarcinomas with gastric and pancreato-biliary morphology and immunohistochemistry.
Procedure: Pancreaduodenectomy and possible adjuvant therapy
Adjuvant therapy was generally offered to patients with T4 or lymph node positive disease. As no national Danish guidelines exist, patients were treated based on the oncologists' preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year survival
Time Frame: Three years
Cumulative survival after three years
Three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duodenal cancer recurrence
Time Frame: 5 years
Recurrence found by computed tomography scan
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1999

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 26, 2021

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Duodenal adenocarcinoma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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