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

Early Gastric Cancer Clinical Trial

— LGE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136354
• Other study ID #: CRE-2009.165T
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Endoscopic Submucosal Dissection

• Laparoscopic assisted Gastrectomy

Locations

Country	Name	City	State
Hong Kong	Combined Endoscopy Center, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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