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

January 14, 2019 updated by: Yonsei University

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Whole precutting group
Procedure: Whole precutting
Whole precutting will be performed prior to dissection during the ESD.
Active Comparator: Partial precutting group
Procedure: Partial precutting
Partial precutting will be performed prior to dissection during the ESD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: Within 5 mins after the procedure
Procedure time for the lesion located in the antrum of lesser curvature according to the precutting methods.
Within 5 mins after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
En bloc resection rate
Time Frame: Within 7 days after the procedure
En bloc resection rate according to the precutting methods.
Within 7 days after the procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete resection rate
Time Frame: Within 7 days after the procedure
complete resection rate according to the precutting methods.
Within 7 days after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2013

Primary Completion (Actual)

August 12, 2014

Study Completion (Actual)

August 12, 2014

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0380

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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