Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...
https://pubmed.ncbi.nlm.nih.gov/33538338Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID05323929
The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2022-04-14
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying early gastric cancer to understand how the depth of endoscopic submucosal dissection (ESD) affects scar formation and patient outcomes. This clinical trial aims to provide clear evidence about the impact of different peeling depths during ESD on scar size, gastric function, and prognosis. The goal is to improve treatment guidelines and techniques for early gastric cancer. Participants will undergo ESD treatment with one of two approaches: either including the deepest third of the submucosa layer (SM3) or not including it. Both groups receive the procedure following standard ESD methods. The study compares these two depths to evaluate how they affect healing and scar formation over time. During the trial, researchers will monitor participants for one year, measuring the scar area and observing gastric function to assess healing. Follow-up visits will include examinations and assessments to track outcomes and overall health. This trial is randomized and double-blind, ensuring careful evaluation of the two ESD techniques over the study period.
CONDITIONS
Brief Title
The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 75 years old.
- Diagnosed with early gastric cancer (T1a stage) confirmed by gastroscopy or ultrasonography.
- Tumors are differentiated with no ulcer; or differentiated with ulcer and lesion diameter less than 3 cm; or undifferentiated with no ulcer and lesion diameter less than 2 cm.
- Pathological diagnosis confirms gastric cancer.
- No further treatment is required.
- First diagnosis without other serious gastrointestinal diseases.
You will not qualify if you...
- Failure to comply with study requirements or switching to other protocols during treatment.
- Advanced gastric cancer or undifferentiated gastric cancer lesions larger than 2 cm.
- Differentiated gastric cancer with ulcer lesions larger than 3 cm.
- Coagulation disorders.
- Serious heart, liver, kidney, or other diseases preventing ESD treatment.
- Gastric cancer complications requiring emergency treatment like bleeding or perforation.
- Presence of distant metastasis.
- Having other tumors or history of malignant tumors except early carcinoma in situ.
- Patient requests withdrawal from the trial.
- Investigator judges participant unsuitable for the study.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure with follow-up as per protocol
Participants undergo Endoscopic Submucosal Dissection (ESD) with different peeling depths for early gastric cancer according to their assigned group.
1 treatment visit (in-person)
Post-operative Follow-up
Duration - Up to 1 year
Participants are monitored to assess scar formation and gastric function after ESD treatment.
Multiple follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Second affiliated hospital, school of medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
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Research Team
Y
Yuqi Wang, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Gastric Cancer Etiology and Management in Asia and the West.
Ashley E Russo, Vivian E Strong
https://pubmed.ncbi.nlm.nih.gov/30355265Natural history of early gastric cancer: a non-concurrent, long term, follow up study.
H Tsukuma, A Oshima, H Narahara...
https://pubmed.ncbi.nlm.nih.gov/110345751,635 Endoscopic submucosal dissection cases in the esophagus, stomach, and colorectum: complication rates and long-term outcomes.
Takashi Toyonaga, Mariko Man-i, James E East...
https://pubmed.ncbi.nlm.nih.gov/23052530Guidelines for endoscopic submucosal dissection and endoscopic mucosal resection for early gastric cancer (second edition).
Hiroyuki Ono, Kenshi Yao, Mitsuhiro Fujishiro...
https://pubmed.ncbi.nlm.nih.gov/33107115Therapeutic outcomes in 1000 cases of endoscopic submucosal dissection for early gastric neoplasms: Korean ESD Study Group multicenter study.
Ii-Kwun Chung, Jun Haeng Lee, Suck-Ho Lee...
https://pubmed.ncbi.nlm.nih.gov/19249769