NCT02764944

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

April 8, 2016

Last Update Submit

May 4, 2016

Conditions

Submucosal Tumor of Stomach

Outcome Measures

Primary Outcomes (1)

  • En bloc resection

    rate of en bloc resection (%)

    During operation

Secondary Outcomes (3)

  • procedure time

    During operation

  • complication

    3 months

  • successful closure of resection site

    1 week

Study Arms (1)

Intervention

EXPERIMENTAL

simple non-exposure EFTR group (single arm study)

Procedure: simple non-exposure EFTR

Interventions

simple non-exposure EFTRPROCEDURE

This intervention 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.

Intervention

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

Study Officials

  • Chan G Kim, M.D.

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan G Kim, M.D.

CONTACT

+82-31-920-1620glse@chol.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

April 8, 2016

First Posted

May 6, 2016

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

May 6, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)