NCT04487002

Brief Summary

it is hypothesized that long term outcomes of localized resection of GIST tumors located in the second part of the duodenum are comparable to those of the traditional treatment by radical resection of the head o pancreas and the entire duodenum

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

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 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

3.9 years

First QC Date

July 18, 2020

Last Update Submit

July 24, 2020

Conditions

Gastrointestinal Stromal Tumor of Duodenum

Keywords

Gastrointestinal stromal tumor of duodenum; localized resection; survival

Outcome Measures

Primary Outcomes (2)

  • survival

    Survival was calculated from the date of surgery to the time of death

    3 years

  • recurrence rate

    . Contrast-enhanced multi-slice CT abdomen/pelvis was performed after 6 months then yearly for detection of recurrence

    3 years

Secondary Outcomes (1)

  • post-operative complications

    one month

Study Arms (1)

group A

EXPERIMENTAL

underwent localized resection

Procedure: surgical resection

Interventions

surgical resectionPROCEDURE
Also known as: localized resection or pancreaticoduodenectomy
group A

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with second part duodenal GIST

You may not qualify if:

  • metastatic, irresectible and unfitness for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Alexandria, Egypt

Location

MeSH Terms

Interventions

Pancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Wael N Abdelsalam, doctor

    dean of faculty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 18, 2020

First Posted

July 27, 2020

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations

EG(1)