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A Prospective Multi-centre Randomized Trial Comparing Endoscopic Submucosal Dissection(ESD) and Laparotomy for Early Stage Gastric Cancer

A Prospective Multi-centre Randomized Trial Comparing Survival between Endoscopic Submucosal Dissection(ESD) and Laparotomy for Early Stage Gastric Cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000754246
Enrollment
80
Registered
2009-08-31
Start date
2009-07-16
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Many articles have suggested that ESD is a safe and effective alternative treatment for early gastric cancer. But there is still no one,which is prospective randomised controlled , to compare ESD and laparotomy for early gastric cancer . So our purpose is to compare esd and laparotomy for early gastric cancer in a prospective randomised controlled way.

Interventions

Endoscopic submucosal dissection (ESD) is an advanced technique of therapeutic endoscopy for superficial gastrointestinal neoplasms. Three steps characterize it:injecting fluid (several fluids such as saline, glycerol and hyaluronic acid are usually combined with diluted epinephrine) into the submucosa to elevate the lesion,cutting the surrounding mucosa of the lesion, and dissecting the submucosa beneath the lesion. The amout of fluid varies according to the size of cancer and the amount is

Endoscopic submucosal dissection (ESD) is an advanced technique of therapeutic endoscopy for superficial gastrointestinal neoplasms. Three steps characterize it:injecting fluid (several fluids such as saline, glycerol and hyaluronic acid are usually combined with diluted epinephrine) into the submucosa to elevate the lesion,cutting the surrounding mucosa of the lesion, and dissecting the submucosa beneath the lesion. The amout of fluid varies according to the size of cancer and the amount is appropriate when the fluid injected can make the cancer safe enough for endoscopists to cut it off. This is a one-off treatment and the duration of ESD itself often varies from one hour to 3 hours.

Sponsors

Linghu Enqiang
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

1.early gastric cancer diagnosed by both gastroscopy and pathological examination. 2.lesion to be mucosal or submucosal by endoscopic ultrasound( EUS).

Exclusion criteria

1.remote metastasis by computed tomography(CT),magnetic resonance imaging(MRI) or positron emission tomography (PET). 2.undifferentiated carcinoma,signet-ring cell carcinoma 3.after treatment of endoscopic electrocoagulation,laser,Argon gas,microwave,endoscopic mucosal resection(EMR) or repeated biopsy in the same lesion.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026