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

Not Applicable

Completed

• Conditions: Early Gastric Cancer
• Interventions: Procedure: Endoscopic Submucosal Dissection; Procedure: Laparoscopic assisted Gastrectomy

• Registration Number: NCT03136354
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2016-11-27
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-02
• Status Verified: 2019-07
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESD Group	Endoscopic Submucosal Dissection	Endoscopic Submucosal Dissection
LAG Group	Laparoscopic assisted Gastrectomy	Laparoscopic Assisted Gastrectomy

Primary Outcome Measures

Name	Time	Method
Complication	30 days after procedure

Secondary Outcome Measures

Name	Time	Method
Disease free survival	up to 5 years after operation
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
Mortality	30 days after procedure
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
Recurrence	up to 5 years after operation
Quality of life assessment by SF36	From date of operation on every followup appointment until 24 months after operation	As measured by SF 36
Overall Survival	up to 5 years after operation
Hospital stay	through study completion, an average of 1 year	The number of days that patient stayed in hospital

Trial Locations

Locations (1)

Combined Endoscopy Center, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong