Early Gastric CancerLGENCT03136354
Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer
A study testing Endoscopic Submucosal Dissection and Laparoscopic assisted Gastrectomy in people with Early Gastric Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- Endoscopic Submucosal Dissection and Laparoscopic assisted Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2009to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Combined Endoscopy Center, Prince of Wales Hospital
Hong Kong, 00000
About this study
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.
- Conditions
- Early Gastric Cancer
- Being tested
- Endoscopic Submucosal Dissection, Laparoscopic assisted Gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Submucosal DissectionProcedure or surgery
Laparoscopic assisted GastrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ESD Group | Active comparator | Endoscopic Submucosal Dissection Receives: Procedure: Endoscopic Submucosal Dissection |
| LAG Group | Active comparator | Laparoscopic Assisted Gastrectomy Receives: Procedure: Laparoscopic assisted Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication
Measured: 30 days after procedure
Secondary outcomes (8)
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
Measured: 30 days
Hospital stay
The number of days that patient stayed in hospital
Measured: through study completion, an average of 1 year
Time (hours) for Operative
The Time measured by hours from start of operation after general anesthesia until end of the operation
Measured: Up to 24 hours
Quality of life assessment by SF36
As measured by SF 36
Measured: From date of operation on every followup appointment until 24 months after operation
Mortality
Measured: 30 days after procedure
Overall Survival
Measured: up to 5 years after operation
Recurrence
Measured: up to 5 years after operation
Disease free survival
Measured: up to 5 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startMay 2009
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Wai Yan Chiu, Chinese University of Hong Kong
- Investigators
- Philip W Chiu, MD, FRCSEd, Principal investigator, Dept of Surgery, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136354
- Sponsor's protocol ID
- CRE-2009.165T
- Acronym
- LGE
- Status last verified
- Jul 2019
- First submitted
- 27 Nov 2016
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer
- ClinicalTrials.gov ID
- NCT03136354
- Acronym / sponsor ID
- LGE / CRE-2009.165T
- Conditions
- Early Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESD Group | Active comparator | Procedure: Endoscopic Submucosal DissectionEndoscopic Submucosal Dissection |
| LAG Group | Active comparator | Procedure: Laparoscopic assisted GastrectomyLaparoscopic Assisted Gastrectomy |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Submucosal Dissection | Procedure or surgery | ESD Group |
| Laparoscopic assisted Gastrectomy | Procedure or surgery | LAG Group |
Primary outcome
Complication
Time frame: 30 days after procedure
8 secondary outcomes
Postop VAS score on pain measurement
Time frame: 30 days
Hospital stay
Time frame: through study completion, an average of 1 year
Time (hours) for Operative
Time frame: Up to 24 hours
Quality of life assessment by SF36
Time frame: From date of operation on every followup appointment until 24 months after operation
Mortality
Time frame: 30 days after procedure
Overall Survival
Time frame: up to 5 years after operation
Recurrence
Time frame: up to 5 years after operation
Disease free survival
Time frame: up to 5 years after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip W Chiu, MD, FRCSEd principal investigator
Dept of Surgery, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Submucosal Dissection and Laparoscopic assisted Gastrectomy in people with Early Gastric Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication (time frame: 30 days after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.