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

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT03136354
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 122
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Early Gastric Cancer	Procedure: Endoscopic Submucosal Dissection; Procedure: Laparoscopic assisted Gastrectomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Complication [30 days after procedure]

Secondary Outcome Measures

1. Postop VAS score on pain measurement [30 days]

   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

2. Hospital stay [through study completion, an average of 1 year]

   The number of days that patient stayed in hospital

3. Time (hours) for Operative [Up to 24 hours]

   The Time measured by hours from start of operation after general anesthesia until end of the operation

4. Quality of life assessment by SF36 [From date of operation on every followup appointment until 24 months after operation]

   As measured by SF 36

5. Mortality [30 days after procedure]

6. Overall Survival [up to 5 years after operation]

7. Recurrence [up to 5 years after operation]

8. Disease free survival [up to 5 years after operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Combined Endoscopy Center, Prince of Wales Hospital	Hong Kong		Hong Kong	00000

Sponsors and Collaborators

• Chinese University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philip Wai Yan Chiu, Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT03136354
• Other Study ID Numbers: CRE-2009.165T
• First Posted: May 2, 2017
• Last Update Posted: Jul 23, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Stomach Neoplasms

Study Results

No Results Posted as of Jul 23, 2019