Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer

NCT ID: NCT03136354

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2019-07-31

Brief Summary

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The investigators compared the perioperative, oncological, functional and immunological outcomes of endoscopic submucosal dissection against laparoscopic assisted gastrectomy for treatment of early gastric cancer. With virtually no abdominal incisions and minimal pain induced, endoscopic submucosal dissection is expected to be less invasive when compared to laparoscopic assisted gastrectomy for treatment of early gastric cancer. This study will show that endoscopic submucosal dissection is associated with a significantly better perioperative recovery and less immunological disturbance. Moreover, it will also induce a better long term outcomes as the stomach can be preserved, hence the digestive function is maintained to prevent long term functional morbidities of the gastrointestinal tract.

This study will be the unique first study in the literature to show that intramucosal early gastric cancer can be adequately treated by endoscopic submucosal dissection with better perioperative, functional and quality of life outcomes when compared to laparoscopic assisted gastrectomy.

Detailed Description

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Conditions

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Early Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ESD Group

Endoscopic Submucosal Dissection

Group Type ACTIVE_COMPARATOR

Endoscopic Submucosal Dissection

Intervention Type PROCEDURE

LAG Group

Laparoscopic Assisted Gastrectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic assisted Gastrectomy

Intervention Type PROCEDURE

Interventions

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Endoscopic Submucosal Dissection

Intervention Type PROCEDURE

Laparoscopic assisted Gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Early gastric cancer with biopsy confirmed high grade dysplasia or adenocarcinoma (intestinal type)
2. Preoperative investigation with magnifying endoscopy and / or EUS predicted to be mucosal lesion
3. Any tumor size if the early gastric cancer has no ulceration
4. Tumor size ≤ 3cm if the early gastric cancer has ulceration

Exclusion Criteria

1. Gastric cancer with preoperative magnifying endoscopy and / or EUS predicted to beyond submucosal invasion
2. Poorly differentiated or signet ring cell adenocarcinoma
3. Age \> 80 or \< 16
4. Pregnancy
5. ASA \> IV
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Philip Wai Yan Chiu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip W Chiu, MD, FRCSEd

Role: PRINCIPAL_INVESTIGATOR

Dept of Surgery, The Chinese University of Hong Kong

Locations

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Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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CRE-2009.165T

Identifier Type: -

Identifier Source: org_study_id

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