Clinical trial NCT03136354: Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Gastric Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complication
timeFrame: 30 days after procedure
Secondary outcomes:
measure: Postop VAS score on pain measurement
timeFrame: 30 days
measure: Hospital stay
timeFrame: through study completion, an average of 1 year
measure: Time (hours) for Operative
timeFrame: Up to 24 hours
measure: Quality of life assessment by SF36
timeFrame: From date of operation on every followup appointment until 24 months after operation
measure: Mortality
timeFrame: 30 days after procedure
measure: Overall Survival
timeFrame: up to 5 years after operation
measure: Recurrence
timeFrame: up to 5 years after operation
measure: Disease free survival
timeFrame: up to 5 years after operation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Combined Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: Dept of Surgery, The Chinese University of Hong Kong
name: Philip W Chiu, MD, FRCSEd
role: PRINCIPAL_INVESTIGATOR
References: