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Endoscopic Full Thickness Resection With Laparoscopic Assistance

Endoscopic Full Thickness Resection With Laparoscopic Assistance, Single Center Single Arm Study

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02042079
Acronym
EFTR-LA
Enrollment
15
Registered
2014-01-22
Start date
2012-07-31
Completion date
Unknown
Last updated
2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Subepithelial Tumor

Keywords

Endoscopic full-thickness resection, gastric subepithelial tumor, hybrid-NOTES

Brief summary

The purpose of this study is to evaluate the feasibility of endoscopic full-thickness resection with laparoscopic assistance.

Detailed description

The laparoscopic resection with a linear stapler for subepithelial tumors (SET) can lead to excessive resection of healthy tissue of the gastric wall resulting in deformity or stenosis. Attaining a positive surgical margin is also possible. Endoscopic full-thickness resection (EFTR) can be used for tumor resection by direct visualization of the tumor from inside the stomach lumen leading to a free surgical margin with little resection of healthy tissue. In order to overcome current endoscopic technical limitations, we will combine the conventional laparoscopic approach with EFTR.

Interventions

PROCEDUREEFTR with LA

(Endoscopic full-thickness resection with laparoscopic assistance)

Sponsors

National Cancer Center, Korea
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Gastric subepithelial tumor * Invasion of muscularis propria on Endoscopic ultrasound * Tumor size 1.5cm-5cm or increasing size during follow-up

Exclusion criteria

* Bleeding tendency, * Inappropriate condition for surgery with general anesthesia * Refuse to be enrolled to study

Design outcomes

Primary

MeasureTime frameDescription
En-bloc resection and successful closure3 months after surgerysuccessful En-bloc resection of subepithelial tumor and successful closure of resection site by Endoscopic full-thickness resection with laparoscopic assistance.

Secondary

MeasureTime frame
number of trocheduring surgery

Countries

South Korea

Contacts

Primary ContactChan G Kim, M.D.
glse@chol.com+82-31-920-1620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026