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

NCT ID: NCT02245971

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-26
• Study Completion Date: 2014-08-12

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).

Conditions

Gastric Adenoma and Early Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whole precutting group

Group Type: ACTIVE_COMPARATOR

Whole precutting

Intervention Type: PROCEDURE

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

Partial precutting group

Group Type: ACTIVE_COMPARATOR

Partial precutting

Intervention Type: PROCEDURE

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

Interventions

Partial precutting

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

Intervention Type: PROCEDURE

Whole precutting

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Over 19 years old

2. Patients with gastric adenoma or early gastric cancer

Exclusion Criteria

1. Patients who has undergone subtotal gastrectomy

2. Patients who has undergone gastrostomy

3. Patients with local recurred gastric adenoma or early gastric cancer

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sevrance hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2014-0380

Identifier Type: -

Identifier Source: org_study_id