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Clinical Trial Details — Status: Completed

Administrative data

NCT 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

Study information

Verified date July 2019
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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