Hydrogel Injection to Assist Endoscopic Submucosal Dissection
कीवर्ड
सार
विवरण
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.
खजूर
| अंतिम सत्यापित: | 10/31/2019 |
| पहले प्रस्तुत किया गया: | 09/19/2017 |
| अनुमानित नामांकन प्रस्तुत किया गया: | 10/21/2017 |
| पहले पोस्ट किया गया: | 10/24/2017 |
| अंतिम अद्यतन प्रस्तुत किया: | 11/18/2019 |
| अंतिम अद्यतन पोस्ट: | 11/26/2019 |
| पहले सबमिट किए गए परिणामों की तारीख: | 08/20/2019 |
| पहले सबमिट किए गए QC परिणामों की तारीख: | 10/07/2019 |
| पहले पोस्ट किए गए परिणामों की तारीख: | 10/30/2019 |
| वास्तविक अध्ययन प्रारंभ दिनांक: | 08/31/2017 |
| अनुमानित प्राथमिक समापन तिथि: | 08/19/2018 |
| अनुमानित अध्ययन पूर्णता तिथि: | 08/19/2018 |
स्थिति या रोग
हस्तक्षेप / उपचार
Device: Endoscopic submucosal dissection
चरण
शाखा समूह
| बांह | हस्तक्षेप / उपचार |
|---|---|
| Experimental: Endoscopic submucosal dissection All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection. | Device: Endoscopic submucosal dissection 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". |
पात्रता मापदंड
| युग अध्ययन के लिए पात्र | 20 Years सेवा 20 Years |
| सेक्स अध्ययन के लिए पात्र | All |
| स्वस्थ स्वयंसेवकों को स्वीकार करता है | हाँ |
| मानदंड | 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). |
परिणाम
प्राथमिक परिणाम उपाय
1. Number of Patients With Postpolypectomy Electrocoagulation Syndrome [5 days after resection]
माध्यमिक परिणाम उपाय
1. Number of Patients With Delayed Bleeding/Perforation [An average of 4 weeks]
2. Number of Patients With Late Tissue Injury [One month after endoscopy]
