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Endoscopic Full Thickness Resection Without Exposure to Peritoneum

N

National Cancer Center (NCC)

Status and phase

Unknown
Phase 1

Conditions

Submucosal Tumor of Stomach

Treatments

Procedure: simple non-exposure EFTR

Study type

Interventional

Funder types

Other

Identifiers

NCT02764944
NCC2015-0171

Details and patient eligibility

About

This study evaluates the feasibility of endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) in patients with gastric tumor.

Full description

Current endoscopic full-thickness resection (EFTR) methods are limited by their transmural communication and exposure of tumor to peritoneum. Recently, endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) was developed. This new technique includes the steps of laparoscopic seromuscular suturing with a barbed suture thread (V-Loc), which results in inversion of the stomach wall; EFTR of the inverted stomach wall from inside the stomach; and finally, endoscopic mucosal suturing with endoloops and clips.

This study evaluates the feasibility of simple non-exposure EFTR technique in patients with gastric tumor. This study is single arm study and will be performed in single center.

Enrollment

12 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Gastric subepithelial tumor
  • Tumor invades of muscularis propria on endoscopic ultrasonography (EUS) finding
  • Tumor size more than 1.5cm or increasing size during observation

Exclusion criteria

  • Tumor size more than 5cm
  • Refuse to be enrolled to study.
  • Bleeding tendency,
  • Inappropriate condition for surgery with general anesthesia

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Intervention
Experimental group
Description:
simple non-exposure EFTR group (single arm study)
Treatment:
Procedure: simple non-exposure EFTR

Trial contacts and locations

1

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Central trial contact

Chan G Kim, M.D.

Data sourced from clinicaltrials.gov

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