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A Study on Precutting Methods of Endoscopic Submucosal Dissection for Gastric Neoplasms Located at Lesser Curvature Side of Antrum

Primary Purpose

Gastric Adenoma and Early Gastric Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Partial precutting

Whole precutting

About this trial

This is an interventional treatment trial for Gastric Adenoma and Early Gastric Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Over 19 years old
Patients with gastric adenoma or early gastric cancer

Exclusion Criteria:

Patients who has undergone subtotal gastrectomy
Patients who has undergone gastrostomy
Patients with local recurred gastric adenoma or early gastric cancer

Sites / Locations

Sevrance hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Whole precutting group

Partial precutting group

Arm Description

Outcomes

Primary Outcome Measures

Procedure time

Procedure time for the lesion located in the antrum of lesser curvature according to the precutting methods.

Secondary Outcome Measures

En bloc resection rate

En bloc resection rate according to the precutting methods.

Full Information

NCT ID

NCT02245971

First Posted

September 15, 2014

Last Updated

January 14, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02245971

Brief Title

A Study on Precutting Methods of Endoscopic Submucosal Dissection for Gastric Neoplasms Located at Lesser Curvature Side of Antrum

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Withdrawn

Why Stopped

The investigators decided to terminate the study early because there were no patient candidates available for registration in the center.

Study Start Date

July 26, 2013 (Actual)

Primary Completion Date

August 12, 2014 (Actual)

Study Completion Date

August 12, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum of lesser curvature side is difficult. Because the antrum of lesser curvature side is dependent position, irrigated water and blood may prevent visual field of ESD. Generally, whole precutting around the lesion during the ESD is performed prior to dissection. However, it is expected that partial precutting method for the lesion located in the antrum of the lesser curvature may improve the visibility of ESD because it can help us the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time of ESD for the lesion located in the antrum of the lesser curvature according to the precutting methods (whole precutting vs. partial precutting).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Adenoma and Early Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Whole precutting group

Arm Type

Active Comparator

Arm Title

Partial precutting group

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Partial precutting

Intervention Description

Partial precutting will be performed prior to dissection during the ESD.

Intervention Type

Procedure

Intervention Name(s)

Whole precutting

Intervention Description

Whole precutting will be performed prior to dissection during the ESD.

Primary Outcome Measure Information:

Title

Procedure time

Description

Procedure time for the lesion located in the antrum of lesser curvature according to the precutting methods.

Time Frame

Within 5 mins after the procedure

Secondary Outcome Measure Information:

Title

En bloc resection rate

Description

En bloc resection rate according to the precutting methods.

Time Frame

Within 7 days after the procedure

Other Pre-specified Outcome Measures:

Title

complete resection rate

Description

complete resection rate according to the precutting methods.

Time Frame

Within 7 days after the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Over 19 years old Patients with gastric adenoma or early gastric cancer Exclusion Criteria: Patients who has undergone subtotal gastrectomy Patients who has undergone gastrostomy Patients with local recurred gastric adenoma or early gastric cancer

Facility Information:

Facility Name

Sevrance hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

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A Study on Precutting Methods of Endoscopic Submucosal Dissection for Gastric Neoplasms Located at Lesser Curvature Side of Antrum

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