Minimal Invasive Surgery for Gastric Subepithelial Tumor

Sponsor
Changhua Christian Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05452265
Collaborator
(none)
194
108

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endoscopic resection

Study Design

Study Type:
Observational
Actual Enrollment :
194 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Different Approach of Minimal Invasive Surgery for Gastric Subepithelial Tumor From A Single-Center Experience
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm 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.

    Outcome Measures

    Primary Outcome Measures

    1. Procedure duration [during the procedure/surgery]

      minutes of procedure time

    2. Length of hospital stay [upto one month after surgery]

      days of hospitalization

    3. Rate of postoperative major complications [upto one month after surgery]

      complications required further intervention, clavien dindo classification upto Grade III

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Changhua Christian Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Changhua Christian Hospital
    ClinicalTrials.gov Identifier:
    NCT05452265
    Other Study ID Numbers:
    • 220117
    First Posted:
    Jul 11, 2022
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Changhua Christian Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 11, 2022