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OpenTrials
Completed

NCT Number: NCT04487002

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with second part duodenal GIST

Exclusion criteria

  • metastatic, irresectible and unfitness for surgery

Treatment and study plan

Surgical resection

Procedure

Other names: localized resection or pancreaticoduodenectomy

Primary outcomes

  1. survival

    Time frame: 3 years

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

  2. recurrence rate

    Time frame: 3 years

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

Secondary outcomes

  1. post-operative complications

    Time frame: one month

    leak, wound infection, chest infection

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: GIST

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2020
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.