Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Early Gastric Cancer
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Complication
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Philip Wai Yan Chiu
Professor
Chinese University of Hong Kong
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
Outcomes
Primary Outcomes
Complication
Time Frame: 30 days after procedure
Secondary Outcomes
- Postop VAS score on pain measurement(30 days)
- Mortality(30 days after procedure)
- Time (hours) for Operative(Up to 24 hours)
- 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)
- Overall Survival(up to 5 years after operation)
- Disease free survival(up to 5 years after operation)
- Hospital stay(through study completion, an average of 1 year)