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Clinical Trials/NCT03136354
NCT03136354
Completed
Not Applicable

Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer

Chinese University of Hong Kong1 site in 1 country36 target enrollmentMay 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Early Gastric Cancer
Sponsor
Chinese University of Hong Kong
Enrollment
36
Locations
1
Primary Endpoint
Complication
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
July 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Philip Wai Yan Chiu

Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Early gastric cancer with biopsy confirmed high grade dysplasia or adenocarcinoma (intestinal type)
  • Preoperative investigation with magnifying endoscopy and / or EUS predicted to be mucosal lesion
  • Any tumor size if the early gastric cancer has no ulceration
  • Tumor size ≤ 3cm if the early gastric cancer has ulceration

Exclusion Criteria

  • Gastric cancer with preoperative magnifying endoscopy and / or EUS predicted to beyond submucosal invasion
  • Poorly differentiated or signet ring cell adenocarcinoma
  • Age \> 80 or \< 16

Outcomes

Primary Outcomes

Complication

Time Frame: 30 days after procedure

Secondary Outcomes

  • Postop VAS score on pain measurement(30 days)
  • Mortality(30 days after procedure)
  • Time (hours) for Operative(Up to 24 hours)
  • Recurrence(up to 5 years after operation)
  • Quality of life assessment by SF36(From date of operation on every followup appointment until 24 months after operation)
  • Overall Survival(up to 5 years after operation)
  • Disease free survival(up to 5 years after operation)
  • Hospital stay(through study completion, an average of 1 year)

Study Sites (1)

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