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

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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Stromal Tumor of Duodenum
• Intervention / Treatment: Procedure: surgical resection

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with second part duodenal GIST

Exclusion Criteria:

• metastatic, irresectible and unfitness for surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; underwent localized resection	Procedure: surgical resection; Other Names: localized resection or pancreaticoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative complications	leak, wound infection, chest infection	one month

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 18, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Gastrointestinal stromal tumor of duodenum; localized resection; survival
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Duodenal Diseases; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors; Duodenal Neoplasms
• Other Study ID Numbers: 441/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No