Minimal Invasive Surgery for Gastric Subepithelial Tumor

NCT05452265 | Completed

• 1 other identifier: 220117
• Study Type: observational
• Target: 194
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastric Subepithelial Tumor

Keywords

gastric subepithelial tumors; endoscopic resection; laparoscopic resection

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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.

Interventions

Endoscopic resection PROCEDURE

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.

Also known as: Laparoscopic resection

endoscopic resection (ER)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 11, 2022
• Study Start: January 1, 2013
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share