NCT04151394

Brief Summary

Lower partial duodenectomy could be indicated in case of injury, wide neck diverticulum, tumor invasion by other tumors such as retroperitoneal sarcoma and primary tumor of 3rd and 4th portion of the duodenum. Reconstruction after resection is usually performed by a end-to-end or end-to-side anastomosis. The investigators analyze the short and long-term results of a case series with resection for various lesions in the third and fourth duodenal portions and reconstruction of the intestinal transit through side-to-side duodenojejunostomy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

October 31, 2019

Last Update Submit

November 14, 2019

Conditions

Duodenal NeoplasmGastrointestinal DiseaseSurgery--ComplicationsSurvival

Outcome Measures

Primary Outcomes (2)

  • Complication

    Surgical complications rates

    90 days

  • Overall survival

    Patients overall survival after resection

    10 years

Interventions

DuodenojejunostomyPROCEDURE

Resection of duodenal lesions and reconstruction by duodenojejunostomy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who, from January 2010 to December 2018, underwent surgical procedures in our unit for duodenal tumors or other type of primary lesions.

You may qualify if:

  • Patients with primary duodenal lesions who underwent surgery

You may not qualify if:

  • Secondary duodenal infiltration or liver and/or peritoneal metastasis found during intraoperative exploration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerardo Blanco-Fernández

Badajoz, 08080, Spain

Location

MeSH Terms

Conditions

Duodenal NeoplasmsGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesDuodenal DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
12 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Surgery, Clinical Professor

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 5, 2019

Study Start

January 31, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

November 18, 2019

Record last verified: 2019-11

Locations

ES(1)