NCT03136354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

10.2 years

First QC Date

November 27, 2016

Last Update Submit

July 22, 2019

Conditions

Early Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Complication

    30 days after procedure

Secondary Outcomes (8)

  • Postop VAS score on pain measurement

    30 days

  • Hospital stay

    through study completion, an average of 1 year

  • Time (hours) for Operative

    Up to 24 hours

  • Quality of life assessment by SF36

    From date of operation on every followup appointment until 24 months after operation

  • Mortality

    30 days after procedure

  • +3 more secondary outcomes

Study Arms (2)

ESD Group

ACTIVE COMPARATOR

Endoscopic Submucosal Dissection

Procedure: Endoscopic Submucosal Dissection

LAG Group

ACTIVE COMPARATOR

Laparoscopic Assisted Gastrectomy

Procedure: Laparoscopic assisted Gastrectomy

Interventions

Endoscopic Submucosal DissectionPROCEDURE
ESD Group
Laparoscopic assisted GastrectomyPROCEDURE
LAG Group

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Pregnancy
  • ASA \> IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong, 00000, Hong Kong

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Philip W Chiu, MD, FRCSEd

    Dept of Surgery, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 27, 2016

First Posted

May 2, 2017

Study Start

May 1, 2009

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)