Early Gastric Cancer
Conditions
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.
Interventions
PROCEDUREEndoscopic Submucosal Dissection
PROCEDURELaparoscopic assisted Gastrectomy
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complication | 30 days after procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital stay | through study completion, an average of 1 year | The number of days that patient stayed in hospital |
| 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 |
| Quality of life assessment by SF36 | From date of operation on every followup appointment until 24 months after operation | As measured by SF 36 |
| 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 |
| Overall Survival | up to 5 years after operation | — |
| Recurrence | up to 5 years after operation | — |
| Disease free survival | up to 5 years after operation | — |
| Mortality | 30 days after procedure | — |
Countries
Hong Kong
Outcome results
None listed