Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESD Group | Active Comparator | Endoscopic Submucosal Dissection |
|
| LAG Group | Active Comparator | Laparoscopic Assisted Gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Submucosal Dissection | Procedure |
| ||
| Laparoscopic assisted Gastrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Complication | 30 days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hospital stay |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philip W Chiu, MD, FRCSEd | Dept of Surgery, The Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Endoscopy Center, Prince of Wales Hospital | Hong Kong | 00000 | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
|
The number of days that patient stayed in hospital |
| through study completion, an average of 1 year |
| 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 |
| Quality of life assessment by SF36 | As measured by SF 36 | From date of operation on every followup appointment until 24 months after operation |
| Mortality | 30 days after procedure |
| Overall Survival | up to 5 years after operation |
| Recurrence | up to 5 years after operation |
| Disease free survival | up to 5 years after operation |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided