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

Study Overview
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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.

Conditions
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Early Gastric Cancer

Intervention / Treatment
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* Procedure: Endoscopic Submucosal Dissection
* Procedure: Laparoscopic assisted Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Early gastric cancer with biopsy confirmed high grade dysplasia or adenocarcinoma (intestinal type) Preoperative investigation with magnifying endoscopy and / or EUS predicted to be mucosal lesion Any tumor size if the early gastric cancer has no ulceration Tumor size ≤ 3cm if the early gastric cancer has ulceration Exclusion Criteria: Gastric cancer with preoperative magnifying endoscopy and / or EUS predicted to beyond submucosal invasion Poorly differentiated or signet ring cell adenocarcinoma Age > 80 or < 16 Pregnancy ASA > IV

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESD Group<br>Endoscopic Submucosal Dissection | Procedure: Endoscopic Submucosal Dissection<br> <br> |
| Active Comparator: LAG Group<br>Laparoscopic Assisted Gastrectomy | Procedure: Laparoscopic assisted Gastrectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication |  | 30 days after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postop VAS score on pain measurement | Measured by VAS pain score daily until the day of discharge by dedicated independent assessor Daily measurement until the day of discharge the type and dose of analgesic requirement is also documented | 30 days | 
| Hospital stay | The number of days that patient stayed in hospital | through study completion, an average of 1 year | 
| Time (hours) for Operative | The Time measured by hours from start of operation after general anesthesia until end of the operation | Up to 24 hours | 
| Quality of life assessment by SF36 | As measured by SF 36 | From date of operation on every followup appointment until 24 months after operation | 
| Mortality |  | 30 days after procedure | 
| Overall Survival |  | up to 5 years after operation | 
| Recurrence |  | up to 5 years after operation | 
| Disease free survival |  | up to 5 years after operation |