Early Gastric Cancer Clinical Trial
— LGENCT number | NCT03136354 |
Other study ID # | CRE-2009.165T |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2009 |
Est. completion date | July 2019 |
Verified date | July 2019 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Combined Endoscopy Center, Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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 |
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