Hydrogel Injection to Assist Endoscopic Submucosal Dissection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Gut Guarding Gel for Endoscopic Resection to Treat Early Gastroenterological Tumor and Polyps (Evaluation of the Safety of Sodium Alginate Mixed With Calcium Lactate on Endoscopic Mucosal Resection / Endoscopic Submucosal Dissection)

Conditions
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Submucosal Tumor of Gastrointestinal Tract

Intervention / Treatment
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* Device: sodium alginate mixed with calcium lactate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all of the following inclusion criteria in order to be entered into the study: A. Both genders of patients age 20 or older. B. Superficial tumors or polyps found either in esophagus, stomach, or large intestine via endoscopic diagnosis. C. Tumor or polyps ≧ 20 millimeters. D. Superficial tumor or polyps found either in esophagus, stomach, or large intestine have never received any kind of endoscopic treatment. E. No evidence of depth of submucosal invasion or metastasis via endoscopy. Exclusion Criteria: If patients meet any of the following criteria they may not be entered into the study: A. Patients suffering from other advanced malignant tumors. B. White Blood Cell< 2000 μL or Severe thrombocytopenia（Platelet count < 50,000 μL)，or blood coagulation abnormalities uncorrectable . C. Patients taking anti- thrombocytopenia or anti-coagulation medicine, and medication cannot be stopped under physicians' consideration. D. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration. E. Evidence of depth of submucosal invasion or metastasis via endoscopy. F. Unable to follow-up by endoscopy. G. Unwilling to sign informed consent. H. Allergic to pharmaceutical excipients related to this medical device (Calcium Lactate or Sodium Alginate).

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic submucosal dissection<br>All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. | Device: sodium alginate mixed with calcium lactate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 days after resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Delayed Bleeding/Perforation | Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection. | 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. | One month after endoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sodium Alginate, Calcium Lactate, Gel