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

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT04487002

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumor of Duodenum	Procedure: surgical resection	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: group A

underwent localized resection

Procedure: surgical resection

Other Names:

localized resection or pancreaticoduodenectomy

Outcome Measures

Primary Outcome Measures

survival [3 years]
Survival was calculated from the date of surgery to the time of death
recurrence rate [3 years]
. Contrast-enhanced multi-slice CT abdomen/pelvis was performed after 6 months then yearly for detection of recurrence

Secondary Outcome Measures

post-operative complications [one month]
leak, wound infection, chest infection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with second part duodenal GIST

Exclusion Criteria:

metastatic, irresectible and unfitness for surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Alexandria		Egypt

Sponsors and Collaborators

Alexandria University

Investigators

Study Director: Wael N Abdelsalam, doctor, dean of faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hani Alhadad, assistant professor, Alexandria University

ClinicalTrials.gov Identifier:

NCT04487002

Other Study ID Numbers:

441/11

First Posted:

Jul 27, 2020

Last Update Posted:

Jul 27, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hani Alhadad, assistant professor, Alexandria University

Gastrointestinal stromal tumor of duodenum; localized resection; survival

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors

Duodenal Neoplasms

Study Results

No Results Posted as of Jul 27, 2020