Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma

Sponsor

Bispebjerg Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05134961

Collaborator

(none)

113

Enrollment

Location

273

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to examine the long-term outcomes after curatively intended resection of duodenal adenocarcinoma.

Condition or Disease	Intervention/Treatment	Phase
Duodenal Cancer	Procedure: Pancreaduodenectomy and possible adjuvant therapy

Study Design

Study Type:

Observational

Actual Enrollment :

113 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma

Actual Study Start Date :

Jan 1, 1999

Actual Primary Completion Date :

Aug 31, 2020

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

3-year survival [Three years]
Cumulative survival after three years

Secondary Outcome Measures

Duodenal cancer recurrence [5 years]
Recurrence found by computed tomography scan

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients subjected to resection of primary duodenal adenocarcinoma

Exclusion Criteria:

None.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kristian Schaumburg Kiim	Copenhagen NV	Copenhagen	Denmark	DK-2400

Sponsors and Collaborators

Bispebjerg Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kristian Kiim Jensen, MD, Ph.d., DMSc, Bispebjerg Hospital

ClinicalTrials.gov Identifier:

NCT05134961

Other Study ID Numbers:

Duodenal adenocarcinoma

First Posted:

Nov 26, 2021

Last Update Posted:

Nov 26, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma

Duodenal Neoplasms

Study Results

No Results Posted as of Nov 26, 2021