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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02245971
Other study ID # 4-2014-0380
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 26, 2013
Est. completion date August 12, 2014

Study information

Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 12, 2014
Est. primary completion date August 12, 2014
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Sevrance hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other complete resection rate complete resection rate according to the precutting methods. Within 7 days after the procedure
Primary Procedure time Procedure time for the lesion located in the antrum of lesser curvature according to the precutting methods. Within 5 mins after the procedure
Secondary En bloc resection rate En bloc resection rate according to the precutting methods. Within 7 days after the procedure