Minimal Invasive Surgery for Gastric Subepithelial Tumor

Different Approach of Minimal Invasive Surgery for Gastric Subepithelial Tumor From A Single-Center Experience

The investigators conducted a retrospective study of those patients with gastric SETs receiving ER or LR at the operative theater in the single institution from January 2013 to December 2021. Medical records were retrospectively reviewed to define patient/tumor characteristics and operative outcomes.

Study Overview

• Status: Completed
• Conditions: Gastric Subepithelial Tumor
• Intervention / Treatment: Procedure: Endoscopic resection

• Study Type: Observational
• Enrollment (Actual): 194

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with gastric SETs who underwent ER or LR at the operative theater in our institution

Description

Inclusion Criteria:

• patients with gastric subepithelial tumors
• patients received minimal invasive surgery (endoscopy or laparoscopy) for tumor resection

Exclusion Criteria:

• patients had gastric anatomic changes due to previous surgery
• patients converted open surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
endoscopic resection (ER); ER with backup surgery was indicated for patients with endoscopic intent, and a small tumor size tolerated endoscopic retrieval.	Procedure: Endoscopic resection; Complete resection of gastric SETs was recommended if the tumor size was >2 cm, presence of malignant features, or if the patient was symptomatic, declined periodical surveillance, and preferred to undergo diagnostic and therapeutic resection.; Other Names: Laparoscopic resection
laparoscopic resection (LR); LR was indicated for patients with surgical intent, and those with the following conditions, which were not suitable for ER: (1) large tumor size with difficult endoscopic retrieval ; (2) symptoms of gastrointestinal tract bleeding with difficulty in endoscopic visualization; (3) suspicion of tumor rupture that required intra-abdominal exploration; and (4) histologic diagnosis of GIST with initial treatment of target therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure duration	minutes of procedure time	during the procedure/surgery
Length of hospital stay	days of hospitalization	upto one month after surgery
Rate of postoperative major complications	complications required further intervention, clavien dindo classification upto Grade III	upto one month after surgery

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2013
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (ACTUAL): July 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: laparoscopic resection; gastric subepithelial tumors; endoscopic resection
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 220117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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