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Gastrointestinal Stromal Tumor of DuodenumGISTNCT04487002

Outcome After Surgical Resection of Gastrointestinal Stromal Tumors (GIST) in the Second Part of Duodenum

A study testing surgical resection in people with Gastrointestinal Stromal Tumor of Duodenum, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
surgical resection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteEgypt
Study dates
Jan 2016to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with second part duodenal GIST

Who cannot join

  • metastatic, irresectible and unfitness for surgery

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medicine

    Alexandria

Other trials in Egypt

About this study

Official title: Outcome After Surgical Treatment of Gastrointestinal Stromal Tumors in the Second Part of Duodenum: Is Localized Resection Appropriate?

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

Read the detailed description

the Medical records of patient with second part duodenal GIST were reviewed retrospectively for symptoms, clinical examination, preoperative workup including standard imaging by multi-slice computed tomography (CT) of abdomen and pelvis with oral and intravenous contrast. Endoscopic ultrasound was routinely perfumed to assess the depth of tumor invasion (T-stage) and to obtain a tissue sample by fine needle aspiration cytology (FNAC). Definitive diagnosis was based on CT images and post-operative pathology report.

Patients were subjected to curative localized resection with free margins by frozen section examination or pancreaticoduodenectomy (PD) if the tumor was invading the major duodenal papilla.

Localized duodenal resection was performed by one of two techniques: The first one was excision of part of the wall (wedge resection). Reconstruction was performed either by primary closure without tension, provided that adequate lumen is preserved, or by side to side roux-en-Y duodenojejunostomy (DJ) if there was tension on the edges of the duodenal defect. The second technique was employed in case of larger size tumors and entailed excision of D2 (segmental duodenectomy) to be followed by anastomosis (side to side roux-en-Y DJ or end-to-end DJ). Great care to avoid tumor rupture was emphasized in all operations. Standard lymph node dissection was not performed.

Pathologic data (tumor location, size, margins, and mitoses per 50 high-power fields [HPF]) and immunohistochemical analysis were collected and tumors classified into very low, low, moderate and high risk based on Miettinen classification that also incorporates tumor size.

All patients (those who underwent localized resection with safety margin and those who underwent PD) were followed up and re-evaluated at one, three, six and twelve months then once per year for a total follow-up period of 3 years. Contrast-enhanced multi-slice CT abdomen/pelvis was performed after 6 months then yearly for detection of recurrence.

Using PASS program version 20, the minimum sample size required was 45 patients with duodenal GIST using 3% local recurrence rate and 5% error at 5% level of significance and 80% power. Data were analyzed using IBM-SPSS software package version 20. Qualitative variables were summarized using numbers and percent. Quantitative variables were summarized using mean and standard deviation (SD) as data was normally distributed by kolmogrov-smirnov test. Survival analysis was done using life tables, log-rank test and Kaplan Meier's curve. All statistical analysis was conducted at 5% level of significance.

Being tested
surgical resection
Keywords
Gastrointestinal stromal tumor of duodenum; localized resection; survival

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surgical resectionProcedure or surgery

    Also called localized resection or pancreaticoduodenectomy

Study groups in NCT04487002
Study groupRoleWhat they receive
group AExperimentalunderwent localized resection
Receives: Procedure: surgical resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. survival

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

    Measured: 3 years

  2. recurrence rate

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

    Measured: 3 years

Secondary outcomes (1)
  1. post-operative complications

    leak, wound infection, chest infection

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study startJan 2016
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04487002
Sponsor's protocol ID
441/11
Acronym
GIST
Status last verified
Jul 2020
First submitted
18 Jul 2020
Last updated
27 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing surgical resection in people with Gastrointestinal Stromal Tumor of Duodenum, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

survival (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.

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