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

Primary Purpose

Early Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Endoscopic Submucosal Dissection
Laparoscopic assisted Gastrectomy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Gastric Cancer

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Combined Endoscopy Center, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ESD Group

LAG Group

Arm Description

Endoscopic Submucosal Dissection

Laparoscopic Assisted Gastrectomy

Outcomes

Primary Outcome Measures

Complication

Secondary Outcome Measures

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
Hospital stay
The number of days that patient stayed in hospital
Time (hours) for Operative
The Time measured by hours from start of operation after general anesthesia until end of the operation
Quality of life assessment by SF36
As measured by SF 36
Mortality
Overall Survival
Recurrence
Disease free survival

Full Information

First Posted
November 27, 2016
Last Updated
July 22, 2019
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03136354
Brief Title
Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer
Acronym
LGE
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESD Group
Arm Type
Active Comparator
Arm Description
Endoscopic Submucosal Dissection
Arm Title
LAG Group
Arm Type
Active Comparator
Arm Description
Laparoscopic Assisted Gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Submucosal Dissection
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic assisted Gastrectomy
Primary Outcome Measure Information:
Title
Complication
Time Frame
30 days after procedure
Secondary Outcome Measure Information:
Title
Postop VAS score on pain measurement
Description
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
Time Frame
30 days
Title
Hospital stay
Description
The number of days that patient stayed in hospital
Time Frame
through study completion, an average of 1 year
Title
Time (hours) for Operative
Description
The Time measured by hours from start of operation after general anesthesia until end of the operation
Time Frame
Up to 24 hours
Title
Quality of life assessment by SF36
Description
As measured by SF 36
Time Frame
From date of operation on every followup appointment until 24 months after operation
Title
Mortality
Time Frame
30 days after procedure
Title
Overall Survival
Time Frame
up to 5 years after operation
Title
Recurrence
Time Frame
up to 5 years after operation
Title
Disease free survival
Time Frame
up to 5 years after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip W Chiu, MD, FRCSEd
Organizational Affiliation
Dept of Surgery, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Combined Endoscopy Center, Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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