search
Back to results

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
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 18, 2020
Last Updated
July 24, 2020
Sponsor
Alexandria University
search

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

We'll reach out to this number within 24 hrs