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

The Chinese University of Hong Kong

Status: Completed

Conditions: Early Gastric Cancer

Treatments: Procedure: Endoscopic Submucosal Dissection; Procedure: Laparoscopic assisted Gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03136354

CRE-2009.165T

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

ESD Group

Active Comparator group

Description:

Endoscopic Submucosal Dissection

Treatment:

Procedure: Endoscopic Submucosal Dissection

LAG Group

Active Comparator group

Description:

Laparoscopic Assisted Gastrectomy

Treatment:

Procedure: Laparoscopic assisted Gastrectomy