The aim of the investigators' study is to evaluate the mucosa-elevating capacity and clinical safety of Sodium Alginate (SA) mixed with Calcium Lactate in assisting Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection.
The study will evaluate the mucosa-elevating capacity and clinical safety of Gut Guarding Gel (the Sodium Alginate (SA) mixed with Calcium Lactate) in assisting Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection to treat early gastroenterological tumor and polyps. All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel". Determine the rates of the delayed bleeding/perforation, postpolypectomy electrocoagulation syndrome, and the late tissue injury.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".
National Cheng Kung University Hospital
Tainan, Taiwan
Number of Patients With Postpolypectomy Electrocoagulation Syndrome
To evaluate patient's clinical symptoms and patient's complaints about the post-polypectomy electrocoagulation syndrome. The post-polypectomy electrocoagulation syndrome occurs after performing the endoscopy, and its signs and symptoms are similar to the signs and symptoms of perforation, such as severe abdominal pain and fever.
Time frame: 5 days after resection
Number of Patients With Delayed Bleeding/Perforation
Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection.
Time frame: An average of 4 weeks
Number of Patients With Late Tissue Injury
To keep follow up the patient's clinical symptoms to evaluate the delayed of bleeding/perforation after one month of hydrogel injection.
Time frame: One month after endoscopy
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