Outcome After Surgical Resection of Gastrointestinal Stromal Tumors (GIST) in the Second Part of Duodenum (GIST)
Primary Purpose
Gastrointestinal Stromal Tumor of Duodenum
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
surgical resection
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumor of Duodenum focused on measuring Gastrointestinal stromal tumor of duodenum; localized resection; survival
Eligibility Criteria
Inclusion Criteria:
- patients with second part duodenal GIST
Exclusion Criteria:
- metastatic, irresectible and unfitness for surgery
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
group A
Arm Description
underwent localized resection
Outcomes
Primary Outcome Measures
survival
Survival was calculated from the date of surgery to the time of death
recurrence rate
. Contrast-enhanced multi-slice CT abdomen/pelvis was performed after 6 months then yearly for detection of recurrence
Secondary Outcome Measures
post-operative complications
leak, wound infection, chest infection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04487002
Brief Title
Outcome After Surgical Resection of Gastrointestinal Stromal Tumors (GIST) in the Second Part of Duodenum
Acronym
GIST
Official Title
Outcome After Surgical Treatment of Gastrointestinal Stromal Tumors in the Second Part of Duodenum: Is Localized Resection Appropriate?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor of Duodenum
Keywords
Gastrointestinal stromal tumor of duodenum; localized resection; survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
underwent localized resection
Intervention Type
Procedure
Intervention Name(s)
surgical resection
Other Intervention Name(s)
localized resection or pancreaticoduodenectomy
Primary Outcome Measure Information:
Title
survival
Description
Survival was calculated from the date of surgery to the time of death
Time Frame
3 years
Title
recurrence rate
Description
. Contrast-enhanced multi-slice CT abdomen/pelvis was performed after 6 months then yearly for detection of recurrence
Time Frame
3 years
Secondary Outcome Measure Information:
Title
post-operative complications
Description
leak, wound infection, chest infection
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with second part duodenal GIST
Exclusion Criteria:
metastatic, irresectible and unfitness for surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael N Abdelsalam, doctor
Organizational Affiliation
dean of faculty
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Outcome After Surgical Resection of Gastrointestinal Stromal Tumors (GIST) in the Second Part of Duodenum
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