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

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.

Study Overview

• Status: Completed
• Conditions: Early Gastric Cancer
• Intervention / Treatment: Procedure: Endoscopic Submucosal Dissection; Procedure: Laparoscopic assisted Gastrectomy

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • Combined Endoscopy Center, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESD Group; Endoscopic Submucosal Dissection	Procedure: Endoscopic Submucosal Dissection
Active Comparator: LAG Group; Laparoscopic Assisted Gastrectomy	Procedure: Laparoscopic assisted Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Philip W Chiu, MD, FRCSEd, Dept of Surgery, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: November 27, 2016
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: CRE-2009.165T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO